CITR Annual Islet
Report Exhibits
Collaborative
Transplant
Registry (CITR)
2009 Annual Report
Exhibits
Prepared by:
CITR Coordinating Center
The EMMES Corporation
Rockville, MD
Sponsored by:
National Institute of Diabetes & Digestive & Kidney Diseases
National Institutes of Health
Juvenile Diabetes Research Foundation
Datafile Closure: April 1, 2009
Insulin Dependent
46.5
Insulin Independent
17.6
No Graft Function
20.8
No Data
15.0
Insulin Dependent
37.9
Insulin Independent
25.9
No Graft Function
21.6
No Data
14.5
Collaborative Islet Transplant Registry 2009.
Follow-up time after initial infusion for each recipient. Top: islet after kidney (N=65), bottom: islet alone (N=347).
Yellow: insulin independence; green: insulin-using with graft function (70% average reduction in daily insulin use
from baseline); black: no islet function; gray: missing data. Red marks indicate reinfusions.
Pie charts show percent of all follow-up time with insulin independence.
Table of Contents
Chapter 1: Islet Transplant Activity
Chapter 2: Recipient and Donor Characteristics
Chapter 3: Pancreas Procurement, Islet Processing, and Infusion
Characteristics
Chapter 4: Immunosuppression and Other Medications
Chapter 5: Graft Function
Chapter 6: Liver, Kidney, Lipid, and PRA Effects
Chapter 7: Adverse Events
Chapter 8: Registry Data Quality Review
CITR Coordinating Center
CITR Committees
Chapter 1: Islet Transplant Activity
Islet Transplant Centers Reporting Data to CITR:
Participating North American Centers 1999-2008
A - CITR Centers with at least one islet allograft infusion procedure conducted in 2008
C - CITR Centers with no islet allograft infusions in 2008
D - CITR Coordinating Center
Islet Transplant Centers Reporting Data to CITR
Participating European Centers 1999-2008
A - CITR Centers with at least one islet allograft infusion procedure conducted in 2008
B - CITR Centers with data reports pending
Islet Transplant Centers Reporting Data to CITR
Participating Australian Centers 1999-2008
A - CITR Centers with at least one islet allograft infusion procedure conducted in 2008
C - CITR Centers with no islet allograft infusions in 2008
Number of Islet Transplantation Centers Performing Islet Allografts per Year
and Number with Data Entered in CITR Database
All North American Islet Transplant Centers 1999-2008
Number of Centers
25
23
20
20
16
20
16
15
16
14
11
15
11
10
9
10
6
15
14
9
6
5
2
0 1999-2000
2001
2002
2003
2004
2005
2006
2007
All North American Centers Performing Islet Allografts (N=32)
CITR-Participating Centers with Data Entered (N=27)
2008
Total Number of Islet Allograft Recipients, Recipients at CITR-Participating Centers, and
Recipients with Detailed Data Reported to CITR by Year of First Islet Allograft Infusion
All North American Islet Transplant Centers 1999-2008
90
82
Number of Recipients
80
75
71
70
65
58
60
53
50
45 44
40
30
20
45
45
38 37
36
55
41
36
32
31 30
30 30
28
25
20 19 19
15
10
0
1999-2000
2001
2002
2003
2004
2005
2006
2007
2008
All North American Recipients (N=408)
All North American CITR Recipients (N=368)
Recipients with Detailed Data Reported to CITR (N=329)
The Islet Transplant Summary (ITS) questionnaire is completed by all North American Islet Transplant
Programs regardless of their participation in the Registry. Of 46 North American islet transplant
programs polled, all have provided this information through 2007.
Total Number of Islet Allograft Recipients and Recipients with Detailed Data
Reported to CITR by Year of First Islet Allograft Infusion
CITR-Participating European and Australian JDRF Centers 1999-2008
40
Number of Procedures
36
35
30
25
25
23
22
21
20
16
15
13
12
13
12
10
10
5
17
16
7
11
7
4
1
0
1999-2000
2001
2002
2003
2004
2005
2006
All European and Australian CITR Recipients (N=183)
Recipients with Detailed Data Reported to CITR (N=83)
2007
2008
Total Number of Islet Allograft Infusion Procedures Performed and
Number with Data Reported to CITR
CITR-Participating North American Islet Transplant Centers 1999-2008
Number of Procedures
160
142
132
125
140
120
110
106
100
125
113109
91 88
95
87
78
80
60
40
50 50
66
65 65
64 63
49
51 49
42
34 34
31
20
0
1999-2000
2001
2002
2003
2004
2005
2006
All Infusions for North American Recipients (N=783)
All Infusions for North American CITR Recipients (N=694)
Infusions with Data Reported to CITR (N=637)
2007
2008
Total Number of Islet Allograft Infusion Procedures Performed and
Number with Data Reported to CITR
CITR-Participating European and Australian JDRF Centers 1999-2008
Number of Procedures
60
50
52
50
43
42
38
40
34
30
32
29
27
28
24
27
22
23
20
12
10
12
9
4
0
1999-2000
2001
2002
2003
2004
2005
2006
2007
All Infusions for European and Australian CITR Recipients (N=326)
Infusions with Data Reported to CITR (N=182)
2008
Total Number (N=828) of Islet Allograft Infusion Procedures Conducted and
Entered in CITR Database, by Year and Infusion Procedure Number
CITR-Participating North American and JDRF Centers, 1999-2008
Number of Islet Infusions
150
141
137
135
115
120
111
105
94
90
72
75
60
45
56
53
40
30
9
15
0 1999-2000 2001
2002
2003
2004
2005
First infusion
Second Infusion
Third Infusion
Fourth Infusion
2006
2007
2008
2009
Number (N=828) of Islet Allograft Infusion Procedures Per Recipient:
CITR-Participating North American and JDRF Centers, 1999-2008
Number of Recipients
220
202
200
180
160
140
120
107
95
100
80
60
40
20
8
0
1
2
3
4
Total Number of Infusions Received
Islet Alone Recipients
Islet After Kidney Recipients
Number of Islet Allograft Infusions
Total Number (N=905) of Deceased Donors per Islet Allograft Infusion Procedure
CITR-Participating North American and JDRF Centers, 1999-2008
800
750
700
650
600
550
500
450
400
350
300
250
200
150
100
50
0
754
71
3
1
2
3
Total Number of Donors Received
Islet Alone and Islet After Kidney Recipients
CITR-Participating North American and JDRF Centers, 1999-2008
Islet Alone
347
Islet After Kidney
65
Chapter 2: Recipient and Donor
Characteristics
Recipient Demographics
Transplant Recipient Primary Funding Information
CITR-Participating US Centers
Recipient Characteristics at First Infusion
Recipient Diabetes Characteristics at First Infusion
Recipient Autoantibodies at First Infusion
Recipient Infectious Disease Testing at First Infusion
Recipient Characteristics at First Infusion by
Total Number of Infusions Received
Recipient Demographics and Characteristics at First Infusion
by Total Number of Infusions Received
Recipient Laboratory Values at First Infusion
Donor Demographics
All Allograft Donors
Donor Characteristics
All Allograft Donors
Donor Characteristics
All Allograft Donors (continued)
Characteristics of Organ Procurement and Donor Cause of Death
All Allograft Donors
Treatments Given to Donor During Hospitalization
All Allograft Donors
Treatments Given to Donor During Hospitalization
All Allograft Donors (continued)
Donor Serology
All Allograft Donors
Donor Laboratory Data
All Allograft Donors
Organ Crossmatch Results
All Allograft Donors
Chapter 3: Pancreas Procurement, Islet
processing and Infusion Characteristics
Pancreas Procurement and Islet Processing
Pancreas Procurement and Islet Processing (continued)
Cold Ischemia Information
Islet Equivalents and Timing of Count
Islet Product Characterization
Islet Product and Infusion Characteristics by Infusion Sequence
Univariate Analysis of Islet Characteristics
by Pancreas Preservation Method
Significant Relationships (p<0.05) between Islet Outcomes and Categorical Predictors
Univariate Analysis
Significant Relationships (p<0.05) between Islet Outcomes and Categorical Predictors
Univariate Analysis (continued)
Significant Relationships (p<0.05) between Islet Outcomes and Categorical Predictors
Univariate Analysis (continued)
Significant Relationships (p<0.05) between Islet Outcomes and Categorical Predictors
Univariate Analysis (continued)
Univariate Correlation of Islet Characteristics
with Donor, Recovery, and Processing Characteristics
Univariate Correlation of Islet Characteristics
with Donor, Recovery, and Processing Characteristics (continued)
Univariate Correlation of Islet Characteristics
with Donor, Recovery, and Processing Characteristics (continued)
Univariate Correlation of Islet Characteristics
with Donor, Recovery, and Processing Characteristics (continued)
Pre Infusion Portal Pressure by Infusion Sequence
30
25
mmHg
20
15
10
5
0
348
248
77
1
2
3
Infusion Sequence
Peak Portal Pressure by Infusion Sequence
40
mmHg
30
20
10
0
328
239
75
1
2
3
Infusion Sequence
Values greater than 40 mmHg are not displayed
(One at infusion 1)
Closure Portal Pressure by Infusion Sequence
40
mmHg
30
20
10
0
343
246
1
76
2
Infusion Sequence
3
Change from Pre Infusion to Closure Portal Pressure by Infusion Sequence
20
15
mmHg
10
5
0
-5
340
245
1
2
75
-10
Infusion Sequence
Values greater than 20 mmHg are not displayed
(One at infusion 1)
3
Change from Pre Infusion to Peak Portal Pressure by Infusion Sequence
20
15
mmHg
10
5
0
327
237
1
2
72
-5
-10
Infusion Sequence
Values greater than 20 mmHg are not displayed
(One at infusion 1)
3
Cell Volume Infused per Infusion by Infusion Year
16.0
Cell Volume (mL)
14.0
12.0
10.0
8.0
6.0
4.0
2.0
0.0
15
1999
24
2000
49
2001
121
2002
95
91
120
83
2003
2004
2005
2006
Infusion Year
This graph represents either settled or packed cell volumes depending on center procedure. Higher volumes
typically represent unpacked cells.
46
2007
50
2008
IEQs Infused per Infusion by Infusion Year
1250000
1000000
IEQs
750000
500000
250000
0
15
24
50
123
106
1999
2000
2001
2002
2003
104
134
93
55
65
2004
2005
2006
2007
2008
Infusion Year
Values greater than 1250000 are not displayed
(One at 2005)
Chapter 4: Immunosuppression and other
Medications
Immunosuppression Regimen at Time of First Infusion
Immunosuppression Regimen at Time of First Infusion (continued)
Biologic Agents Used Peri First Infusion for Induction Therapy
Biologic Agents Used Peri First Infusion for Induction Therapy
Year of 1s t I nf us i on
07- 08
67
41
16
05- 06
111
88
30
03- 04
100
86
36
01- 02
115
62
9
99- 00
19
1
13
2
I nf us i on Sequenc e
Ant i CD3*
Ant i I L2Al one
Ant i I L2+DSG
Ant i I L2+TNFB
MonoTCDAl one
4
3
MonoTCD+Ant i I L2/ TNFB
Pol y TCD al one
Pol y TCD+TNFB
Pol y TCD+AI L2( +/ - TNFB)
Unr epor t ed
Induction immunosuppression combinations given to allograft recipients, according to infusion sequence (horizontal axis), and
transplantation era (1999-2000, 01-02. etc, perspective axis). Substantial shifts away from Anti-IL2 alone (blue) to other
combinations is evident in recent time periods.
Immunosuppression Therapy Use at Specified Times Post Last Infusion
Allograft Recipients without Reported Graft Failure at the Time of Follow-Up
Immunosuppression Therapy Use at Specified Times Post Last Infusion
Allograft Recipients without Reported Graft Failure at the Time of Follow-Up
(continued)
Maintenance Immunosuppression Therapy Use Post Initial Infusion
by Transplantation Era
Year of 1st I nf usi on
07- 08
67
50
39
5
05- 06
111
111
111
111
75
6
03- 04
100
100
100
100
100
91
46
01- 02
115
115
115
115
115
115
113
99- 00
19
0
19
6
Cal ci
Cal ci
Cal ci
mTOR
19
19
19
12
24
36
48
Mont hs Post Fi r st I nf usi on
neur i nI nh+mTOR
neur i nI nh+I nosi neI nh
ner i nI nh+mTOR+I nosi neI nh
Al one/ +I nosi neI nh/ +St er oi d
19
19
60
Al l Ot her Combi nat i ons
Gr af t Fai l ur e
No Dat a
Maintenance immunosuppression combinations given to allograft recipients, according to time (months from initial infusion,
horizontal axis), and transplantation era (1999-2000, 01-02. etc, perspective axis). The total number expected at each follow-up time
point is accounted for. Complete graft loss trumps any immunosuppression. Substantial shifts away from the Calcineurin+mTOR
combination (yellow) to other combinations is evident from the start in recent time periods )2007-2008), as well as among those
infused in earlier eras (e.g., 2001-2006) and still on immunosuppression at long-term follow-up (2-5 years).
Sirolimus Trough (ng/mL)
Sirolimus Recipient Trough Level (ng/mL) Post Last Infusion
All Allograft Recipients
50.00
40.00
30.00
20.00
10.00
0.00
292
Inf 1
218
Inf 2
66
225
178
113
71
37
Inf 3 Month 6Year 1 Year 2 Year 3 Year 4
Day 30 Day 30 Day 30
Follow-Up
Values greater than 60 ng/mL are not displayed
(One at inf 1 day 30 and one at inf 3 day 30)
Tacrolimus Trough (ng/mL)
Tacrolimus Recipient Trough Level (ng/mL) Post Last Infusion
All Allograft Recipients
20.00
15.00
10.00
5.00
0.00
301
Inf 1
222
Inf 2
69
238
206
142
87
57
Inf 3 Month 6Year 1 Year 2 Year 3 Year 4
Day 30 Day 30 Day 30
Follow-Up
Anti-Hypertensive Medications Pre Infusion and Post Last Infusion
All Allograft Recipients
Total Number of Anti-Hypertensive Medications
Pre Infusion and Post Last Infusion
All Allograft Recipients
Percent of Recipients
80
70
60
50
40
30
20
10
0
Pre Infusion 1
Month 6
Year 1
Total Number of Medications
Year 2
Year 3
4
3
2
1
Year 4
Lipid Lowering Medications Pre Infusion and Post Last Infusion
All Allograft Recipients
Total Number of Lipid Lowering Medications
Pre Infusion and Post Last Infusion
All Allograft Recipients
Percent of Recipients
80
70
60
50
40
30
20
10
0 Pre Infusion 1
Month 6
Year 1
Year 2
Total Number of Medications
Year 3
2
1
Visit Year 4
Adjunctive Therapy Used at Time of First Infusion
All Allograft Recipients
Antibiotics
Antifungals
Antivirals
Aspirin
Enoxaparin
Iron Supplements
Metformin
Nicotinamide
Ondansetron Hydrochloride
Pantoprazole
Pentoxifylline
Pioglitazone
Rosiglitizone
Vitamins
0
10
20
30
40
50
60
Percent of Recipients
70
80
90
100
Adjunctive Therapy Post Last Infusion
All Allograft Recipients
Chapter 5: Graft Function
Insulin Independence, Insulin Dependence,
Absence of Fasting C-peptide, or Re-Infusion
Post First Infusion
A. Islet Alone Recipients
80
Percent of Recipients
70
60
50
40
30
20
10
0
Day 30
N=347
Recipient Status
Day 75
N=346
Month 6
N=328
Year 1
N=318
Year 3*
N=257
Re-Infused Prior to Follow-Up
Insulin Independent
Insulin Dependent with Detectable Fasting C-peptide
No Detectable Fasting C-peptide or Known Graft Loss
Missing Data
*Year 3 status regardless of re-infusion
Insulin Independence, Insulin Dependence,
Absence of Fasting C-peptide, or Re-Infusion
Post First Infusion
B. Islet After Kidney Recipients
80
Percent of Recipients
70
60
50
40
30
20
10
0
Day 30
N=65
Recipient Status
Day 75
N=65
Month 6
N=65
Year 1
N=61
Year 3*
N=47
Re-Infused Prior to Follow-Up
Insulin Independent
Insulin Dependent with Detectable Fasting C-peptide
No Detectable Fasting C-peptide or Known Graft Loss
Missing Data
*Year 3 status regardless of re-infusion
Insulin Independence, Insulin Dependence
or Absence of Fasting C-peptide
Post Last Infusion
A. Islet Alone Recipients
70
Percent of Recipients
60
50
40
30
20
10
0
Month 6
N=314
Recipient Status
Year 1
N=298
Year 2
N=266
Year 3
N=216
Year 4
N=155
Insulin Independent
Insulin Dependent with Detectable Fasting C-peptide
No Detectable Fasting C-peptide or Known Graft Loss
Missing Data
Insulin Independence, Insulin Dependence or
Absence of Fasting C-peptide
Post Last Infusion
B. Islet After Kidney Recipients
70
Percent of Recipients
60
50
40
30
20
10
0
Month 6
N=63
Recipient Status
Year 1
N=59
Year 2
N=49
Year 3
N=42
Year 4
N=35
Insulin Independent
Insulin Dependent with Detectable Fasting C-peptide
No Detectable Fasting C-peptide or Known Graft Loss
Missing Data
Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptide
Post Last Infusion by Total Number of Infusions Received
Islet Alone Recipients
A. Recipients of 1 Infusion
70
Percent of Recipients
60
50
40
30
20
10
0
Month 6
N=81
Recipient Status
Year 1
N=77
Year 2
N=63
Year 3
N=48
Year 4
N=37
Insulin Independent
Insulin Dependent with Detectable Fasting C-peptide
No Detectable Fasting C-peptide or Known Graft Loss
Missing Data
Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptide
Post Last Infusion by Total Number of Infusions Received
Islet Alone Recipients
B. Recipients of 2 Infusions
70
Percent of Recipients
60
50
40
30
20
10
0
Month 6
N=155
Recipient Status
Year 1
N=147
Year 2
N=133
Year 3
N=112
Year 4
N=77
Insulin Independent
Insulin Dependent with Detectable Fasting C-peptide
No Detectable Fasting C-peptide or Known Graft Loss
Missing Data
Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptide
Post Last Infusion by Total Number of Infusions Received
Islet Alone Recipients
C. Recipients of 3 Infusions
70
Percent of Recipients
60
50
40
30
20
10
0
Month 6
N=78
Recipient Status
Year 1
N=74
Year 2
N=70
Year 3
N=56
Year 4
N=41
Insulin Independent
Insulin Dependent with Detectable Fasting C-peptide
No Detectable Fasting C-peptide or Known Graft Loss
Missing Data
Prevalence of Insulin Independence Post Last Infusion
Islet Alone Recipients
70
Percent Insulin Independent
60
50
40
30
20
10
0
0
3
6
9 12 15 18 21 24 27 30 33 36 39 42 45 48
Months Post Last Infusion
Best Case
Reported
Worst Case
Prevalence of Insulin Independence Post Last Infusion
By Total Number of Infusions Received
Islet Alone Recipients
70
Percent Insulin Independent
60
50
40
30
20
10
0
0
3
6
9 12 15 18 21 24 27 30 33 36 39 42 45 48
Months Post Last Infusion
Total Number of Infusions Received
One
Two
Three+
Achievement of Insulin Independence
Persistence of Insulin Independence
Allograft Recipients Achieving Insulin Independence
Average Daily Insulin (Units)
Baseline and Post Last Infusion
A. Islet Alone Recipients
Average Daily Insulin Use (Units)
100
80
60
40
20
0
330
279
Pre Infusion 1 Month 6
258
221
171
114
Year 1
Year 2
Year 3
Year 4
Follow-Up
Average Daily Insulin (Units) Taken By
Recipients on Insulin
Baseline and Post Last Infusion
B. Islet After Kidney Recipients
Average Daily Insulin Use (Units)
100
80
60
40
20
0
62
51
Pre Infusion 1 Month 6
48
Year 1
38
Year 2
Follow-Up
32
23
Year 3
Year 4
Average Daily Insulin (Units/Kg)
Baseline and Post Last Infusion
A. Islet Alone Recipients
Average Daily Insulin Use (Units/kg)
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0
326
279
Pre Infusion 1 Month 6
258
221
170
114
Year 1
Year 2
Year 3
Year 4
Follow-Up
Average Daily Insulin (Units/Kg)
Baseline and Post Last Infusion
B. Islet After Kidney Recipients
Average Daily Insulin Use (Units/kg)
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0
60
51
Pre Infusion 1 Month 6
48
38
32
23
Year 1
Year 2
Year 3
Year 4
Follow-Up
Percent of Baseline Insulin
Follow-Up Post Last Infusion
A. Islet Alone Recipients
Percent of Recipients
100
80
60
40
20
0
Month 6
Year 1
Year 2
Year 3
Year 4
N=314
N=298
N=266
N=216
N=155
0%
<25%
25-49%
50-74%
>=75%
Missing Data
Percent of Baseline Insulin
Follow-Up Post Last Infusion
B. Islet After Kidney Recipients
Percent of Recipients
100
80
60
40
20
0
Month 6
Year 1
Year 2
Year 3
Year 4
N=63
N=59
N=49
N=42
N=35
0%
<25%
25-49%
50-74%
>=75%
Missing Data
Complete Islet Graft Failure Post Last Infusion
A. Islet Alone Recipients
100
90
Percent of Recipients
80
70
60
50
40
30
20
10
0
Day 30 Month 6 Year 1 Year 2 Year 3
N=347 N=314 N=298 N=266 N=216
Complete Graft Failure
Missing Data
Graft Function
Year 4
N=155
Complete Islet Graft Failure Post Last Infusion
B. Islet After Kidney Recipients
100
90
Percent of Recipients
80
70
60
50
40
30
20
10
0
Day 30 Month 6 Year 1
N=65
N=63
N=59
Year 2
N=49
Year 3
N=42
Complete Graft Failure
Missing Data
Graft Function
Year 4
N=35
Persistence of Graft Function
All Allograft Recipients
Outcomes Post First Infusion
Outcomes Post Second Infusion
Outcomes Post Third Infusion
Primary Outcomes Post First Infusion Up to Re-Infusion,
Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet Characteristics
Islet Alone Recipients
Primary Outcomes Post First Infusion Up to Re-Infusion,
Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet Characteristics
Islet Alone Recipients (continued)
Primary Outcomes Post First Infusion Up to Re-Infusion,
Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet Characteristics
Islet Alone Recipients (continued)
Primary Outcomes Post First Infusion Up to Re-Infusion,
Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet Characteristics
Islet Alone Recipients (continued)
Primary Outcomes Post First Infusion Up to Re-Infusion,
Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet Characteristics
Islet Alone Recipients (continued)
Primary Outcomes Post First Infusion Up to Re-Infusion,
Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet Characteristics
Islet Alone Recipients (continued)
Primary Outcomes Post First Infusion Up to Re-Infusion,
Complete Islet Failure, or Last Follow-Up According to Pre-Infusion Recipient,
Donor, Procurement, and Islet Characteristics
Islet Alone Recipients (continued)
Achievement of Insulin Independence Post First Infusion
Forest Plot (Hazard Ratio ± 95% Confidence Interval)
Of Factors Univariately Significant p < 0.10
Factors
-1
Recipient gender (0=M 1=F)
Baseline daily insulin use (Units)
Baseline weight (10-kg)
Baseline BMI
Baseline number of daily insulin injections
Baseline HbA1c (%)
Baseline fasting glucose (mg/dL)
Donor race (0=W 1=Non-white)
Donor(s) blood type (1=A,B,AB 2=O)
Donor(s) given vasopressors (0=N 1=Y)
Donor(s) given steroids (0=N 1=Y)
Donor(s) weight (10-kg)
Donor(s) BSA
Donor(s) BMI
Procurement/infusion teams (0-Unrelated 1-Related)
Gradient type
Donor(s)-recipient age difference (x10-yrs)
Donor(s)-recipient BMI difference (x10)
Donor(s) CMV+ / Recipient CMV- (0=N 1=Y)
Death to pancreas recovery (hrs)
Cold ischemia time (hrs)
Islet Viability (%)
Viability > 87% (0=N 1=Y)
T otal IEQs at time of islet count (1000s)
T otal volume infused over all infusions (ml)
Cumulative IEQs infused (1000s)
Cumulative IEQs infused/kg recipient (100s)
Anti-CD3
Etanercept
0.125
0.25
0.5
1
Hazard ratio (95% CI)
2
4
8
Loss of Insulin Independence Post First Infusion
Forest Plot (Hazard Ratio ± 95% Confidence Interval)
Of Factors Univariately Significant p < 0.10
Factors
-1
Cohort 1999-2004/05-08
Diabetes Duration (years)
Baseline HbA1c (%)
Baseline C-peptide (ng/mL)
Donor(s) Hispanic (0=N 1=Y)
Donor(s) ET OH (0=N 1=Y)
Donor(s) given vasopressors (0=N 1=Y)
Donor(s) insulin (0=N 1=Y)
Donor(s) AST
Donor(s) ALT
Procurement/infusion teams (0-Unrelated 1-Related)
Processing/infusion center (0-Unrelated 1-Related)
Cultured >6 hrs (0=N 1=Y)
Culture time (hrs)
Genders match (0=N 1=Y)
Cold ischemia time (hrs)
Stimulation index
Stimulation index <2/2-3.5/>=3.5
T otal beta cells/kg donor
T otal insulin content of islets
T otal endotoxin infused
T otal endotoxin infused/kg donor
T otal volume infused over all infusions (ml)
Anti-Il2
Daclizumab
Sirolimus
Poly or mono T -cell AB + calc inh + (mtor OR inosine)
Monoclonal anti-IL2R + calc inh + (mtor OR inosine)
0.125
0.25
0.5
1
Hazard ratio (95% CI)
2
4
8
Complete Islet Failure Post First Infusion
Forest Plot (Hazard Ratio ± 95% Confidence Interval)
Of Factors Univariately Significant p < 0.10
Factors
-1
Recipient age (years)
Diabetes Duration (years)
Baseline BMI
Years intensive therapy
Intensive therapy <10/10-25/>=25 yrs
Baseline HbA1c (%)
Baseline GAD 65 AABs (0,1)
Baseline IA-2 AABs (0,1)
Baseline insulin AABs (0,1)
Baseline total positive AABs (0,1,2,3)
Donor race (0=W 1=Non-white)
Donor(s) insulin (0=N 1=Y)
Processing/infusion ctr (0-Unrelated 1-Related)
Cultured >6 hrs (0=N 1=Y)
Culture time (hrs)
Donor(s)-recipient age difference (x10-yrs)
T otal beta cells/kg donor
IEQ/islet particle ratio
Isletsize (0-small 1-large)
T NF blocker
Etanercept
Calcineurin inhibitor
T acrolimus
MonoAntiIL2R+T NFa+CalcInh+mT OR/inosine
0.125
0.25
0.5
1
Hazard ratio (95% CI)
2
4
8
Reinfusion Post First Infusion
Forest Plot (Hazard Ratio ± 95% Confidence Interval)
Of Factors Univariately Significant p < 0.10
Factors
-1
Cohort 1999-2004/05-08
Recipient gender (0=M 1=F)
Baseline daily insulin use (Units)
Baseline weight (10-kg)
Baseline use of insulin pump (0=N 1=Y)
Baseline HbA1c (%)
Donor age (x10 yrs)
Donor(s) blood type (1=A,B,AB 2=O)
Donor(s) ET OH (0=N 1=Y)
Donor(s) insulin (0=N 1=Y)
Donor(s) weight (10-kg)
Donor(s) BSA
Donor(s) BMI
Donor(s) serum lipase
Any positive crossmatch (0=N 1=Y)
Collagenase (1=Liberase alone 2=Other)
Donor(s)-recipient age difference (x10-yrs)
Donor(s)-recipient BMI difference (x10)
Recipient insulin day 0 (0=N 1=Y)
Death to pancreas recovery (hrs)
Recovery to transplant (hrs)
Death to cross-clamp (hrs)
Death to transplant (hrs)
Islet Viability (%)
Viability > 87% (0=N 1=Y)
T otal beta cells (1000s)
T otal beta cells/kg donor
Endotoxin/kg <0.6/.06-3.0/>=3.0
T otal IEQs at time of islet count (1000s)
T otal volume infused over all infusions (ml)
Cumulative IEQs infused (1000s)
Cumulative IEQs infused/kg recipient (100s)
IEQ/islet particle ratio
Poly T -cell depleting
Rabbit thymoglobulin
Anti-Il2
Daclizumab
Anti-CD3
T NF blocker
Infliximab
Etanercept
Calcineurin inhibitor
T acrolimus
Sirolimus or Everolimus
Sirolimus
Inosine: MMF or mycophenolic acid
MMF
Prednisone, Methylprednisolone, or other steroid
Poly/mono T -cell AB + CalcInh + mT OR/nosine)
Poly/mono T -cell AB + T NF-a + CalcInh + mT OR/Inosine
Monoclonal anti-IL2R + calc inh + (mtor OR inosine)
0.125
0.25
0.5
1
Hazard ratio (95% CI)
2
4
8
Primary Outcomes Post Last Infusion
According to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
Primary Outcomes Post Last Infusion
According to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
(continued)
Primary Outcomes Post Last Infusion
According to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
(continued)
Primary Outcomes Post Last Infusion
According to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
(continued)
Primary Outcomes Post Last Infusion
According to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
(continued)
Primary Outcomes Post Last Infusion
According to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
(continued)
Achievement of Insulin Independence Post Last Infusion
Forest Plot (Hazard Ratio ± 95% Confidence Interval)
of Factors Univariately Significant p < 0.10
Factors
Baseline HbA1c (%)
Donor(s) Hispanic (0=N 1=Y)
Donor race (0=W 1=Non-white)
Donor(s) ET OH (0=N 1=Y)
Donor(s) given steroids (0=N 1=Y)
Donor(s) height (cm)
Donor(s) creatinine
Donor(s) BUN
Procurement/infusion teams (0-Unrelated 1-Related)
Processing/infusion center (0-Unrelated 1-Related)
Gradient type
Recipient insulin day 0 (0=N 1=Y)
T ime from admission to death (hrs)
Recovery to transplant (hrs)
Viability > 87% (0=N 1=Y)
Poly T -cell depleting
Rabbit thymoglobulin
Anti-Il2
Daclizumab
Calcineurin inhibitor
T acrolimus
Inosine: MMF or mycophenolic acid
MMF
Poly/MonoT -cellAB + T NF-aAnt + CalcInh + mT OR/Inosine
MonoAntiIL2R + CalcInh + mT OR/Inosine
Number of A locus mismatches
Number of B locus mismatches
Number of Class I locus mismatches
Number of A/B/DR locus mismatches
Number of A/B/DR/DQ locus mismatches
Reexposed to B locus mismatch
0.125
0.25
0.5
1
Hazard ratio (95% CI)
2
4
8
Loss of Insulin Independence Post Last Infusion
Forest Plot (Hazard Ratio ± 95% Confidence Interval)
of Factors Univariately Significant p < 0.10
Factors
Diabetes Duration (years)
Baseline daily insulin use (Units)
Baseline use of insulin pump or >=3 insulin inject
Baseline C-peptide (ng/mL)
Baseline GAD 65 autoantibodies (0,1)
Donor age (x10 yrs)
Donor(s) given vasopressors (0=N 1=Y)
Donor(s) insulin (0=N 1=Y)
Donor(s) bilirubin
Processing/infusion center (0-Unrelated 1-Related)
Donor(s)-recipient age difference (x10-yrs)
Isletsize (0-small 1-large)
Rabbit thymoglobulin
Anti-Il2
Daclizumab
Infliximab
Sirolimus
Inosine: MMF or mycophenolic acid
MMF
Prednisone, Methylprednisolone, or other steroid
MonoAnti-IL2R + CalcInh + mT OR/Inosine
0.125
0.25
0.5
1
Hazard ratio (95% CI)
2
4
8
Complete Islet Failure Post Last Infusion
Forest Plot (Hazard Ratio ± 95% Confidence Interval)
of Factors Univariately Significant p < 0.10
Factors
Recipient age (years)
Employment impacted by dx
Diabetes Duration (years)
Baseline use of insulin pump (0=N 1=Y)
Years prior to first inf using ins pump or >= 3 in
Intensive therapy <10/10-25/>=25 yrs
Baseline HbA1c (%)
Baseline C-peptide (ng/mL)
Baseline IA-2 autoantibodies (0,1)
Baseline total positive autoantobodies (0,1,2,3)
T otal donors
Donor race (0=W 1=Non-white)
Donor(s) BMI
Procurement/infusion teams (0-Unrelated 1-Related)
Processing/infusion center (0-Unrelated 1-Related)
Cultured >6 hrs (0=N 1=Y)
Culture time (hrs)
Donor(s)-recipient age difference (x10-yrs)
Recovery to transplant (hrs)
Death to transplant (hrs)
Stimulation index
Islet Viability (%)
Viability > 87% (0=N 1=Y)
T otal beta cells/kg donor
Horse thymoglobulin
Anti-Il2
Daclizumab
T NF blocker
Etanercept
Calcineurin inhibitor
T acrolimus
MMF
MonoAnti-IL2R + T NF-aAnta + CalcInh + mT OR/Inosine
Reexposed to A locus mismatch
0.125
0.25
0.5
1
Hazard ratio (95% CI)
2
4
8
C-peptide  0.5 ng/mL
A. Post First Infusion (Censored at Re-Infusion before Visit)
Islet Alone Recipients
90
80
Percent of Recipients
70
60
50
40
30
20
10
0
Pre Inf 1
N=347
Month 6
152
C-peptide < 0.5 ng/mL or Known Graft Loss
C-peptide >= 0.5 ng/mL
Missing data
Year 1
112
C-peptide  0.5 ng/mL
A. Post First Infusion (Censored at Re-Infusion before Visit)
Islet After Kidney Recipients
90
80
Percent of Recipients
70
60
50
40
30
20
10
0
Pre Inf 1
N=65
Month 6
24
C-peptide < 0.5 ng/mL or Known Graft Loss
C-peptide >= 0.5 ng/mL
Missing data
Year 1
16
C-peptide  0.5 ng/mL
B. Post Last Infusion
Islet Alone Recipients
90
80
Percent of Recipients
70
60
50
40
30
20
10
0
Pre Inf 1
N=347
Month 6
314
Year 1
298
Year 2
266
Year 3
216
C-peptide < 0.5 ng/mL or Known Graft Loss
C-peptide >= 0.5 ng/mL
Missing data
Year 4
155
C-peptide  0.5 ng/mL
B. Post Last Infusion
Islet After Kidney Recipients
90
80
Percent of Recipients
70
60
50
40
30
20
10
0
Pre Inf 1
N=65
Month 6
63
Year 1
59
Year 2
49
Year 3
42
C-peptide < 0.5 ng/mL or Known Graft Loss
C-peptide >= 0.5 ng/mL
Missing data
Year 4
N35
C-peptide  0.3 ng/mL
C. Post Last Infusion
With or Without Missing Data
Basal Plasma C-Peptide (ng/mL)
Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
6
6
5
5
4
4
ng/mL
ng/mL
A. Islet Alone Recipients
3
3
2
2
1
1
0
325
229
78
Pre Inf 1 Pre Inf 2 Pre Inf 3
291
276
239
Month 6
Year 1
Year 2
182
Year 3
120
Year 4
Follow-Up
Values greater than 6 ng/ml are not displayed or used in boxplot values
(One at pre-inf 2, three at month 6, one at year 1, and one at year 3)
0
57
46
11
Pre Inf 1 Pre Inf 2 Pre Inf 3
56
53
39
32
22
Month 6
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 6 ng/ml are not displayed or used in boxplot values
(One at year 2)
Association of Islet Graft Function with Insulin Independence:
Percent Insulin Independent by C-peptide Level Post Last Infusion
Basal Plasma C-Peptide (ng/mL)
Pre and Post First Infusion
Insulin Independent Recipients
B. Islet After Kidney Recipients
6
6
5
5
4
4
ng/mL
ng/mL
A. Islet Alone Recipients
3
3
2
2
1
1
0
325
14
36
150
154
Pre Inf 1
Day 7
Day 30
Month 6
Year 1
Follow-Up
Values greater than 6 ng/mL are not displayed or used in boxplot values
(One at month 6 and one at year 1)
0
57
1
Pre Inf 1
Day 7
6
25
19
Day 30
Month 6
Year 1
Follow-Up
Basal Plasma C-Peptide (ng/mL)
Pre and Post First Infusion
Insulin Dependent Recipients
B. Islet After Kidney Recipients
6
6
5
5
4
4
ng/mL
ng/mL
A. Islet Alone Recipients
3
3
2
2
1
1
0
325
266
280
141
135
Pre Inf 1
Day 7
Day 30
Month 6
Year 1
Follow-Up
Values greater than 6 ng/mL are not displayed or used in boxplot values
(One at day 7)
0
57
40
46
28
30
Pre Inf 1
Day 7
Day 30
Month 6
Year 1
Follow-Up
Values greater than 6 ng/mL are not displayed or used in boxplot values
(One at day 30)
Percent of Insulin Dependent Recipients with Basal C-Peptide  0.5 ng/mL
Post Last Infusion
B. Islet After Kidney Recipients
70
70
60
60
50
50
Percent of Recipients
Percent of Recipients
A. Islet Alone Recipients
40
30
40
30
20
20
10
10
0
Pre Inf 1 Month 6 Year 1
N=347
131
147
Year 2
148
Year 3
122
Year 4
96
0
Pre Inf 1 Month 6 Year 1
N=65
22
30
Year 2
30
Year 3
33
Year 4
23
Fasting Plasma Glucose (mg/dL)
Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
400
400
300
300
mg/dL
mg/dL
A. Islet Alone Recipients
200
100
0
200
100
320
242
84
300
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
281
237
179
116
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 400 mg/dL are not displayed or used in boxplot values
(Five at pre-inf 1, one at month 6, one at year 1, tw o at year 2, one at year 3 and tw o at year 4)
0
56
48
13
57
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
54
42
37
23
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 400 mg/dL are not displayed or used in boxplot values
(Tw o at pre-inf 1, one at year 2 and one at year 4)
Fasting Plasma Glucose (mg/dL)
Pre and Post First Infusion
Insulin Independent Recipients
B. Islet After Kidney Recipients
400
400
300
300
mg/dL
mg/dL
A. Islet Alone Recipients
200
100
0
200
100
320
18
38
144
145
Pre Inf 1
Day 7
Day 30
Month 6
Year 1
Follow-Up
Values greater than 400 mg/dL are not displayed or used in boxplot values
(Five at pre-inf 1)
0
56
2
7
24
18
Pre Inf 1
Day 7
Day 30
Month 6
Year 1
Follow-Up
Values greater than 400 mg/dL are not displayed or used in boxplot values
(Tw o at pre-inf 1)
Fasting Plasma Glucose (mg/dL)
Pre and Post First Infusion
Insulin Dependent Recipients
B. Islet After Kidney Recipients
400
400
300
300
mg/dL
mg/dL
A. Islet Alone Recipients
200
100
0
200
100
320
284
285
153
142
Pre Inf 1
Day 7
Day 30
Month 6
Year 1
Follow-Up
Values greater than 400 mg/dL are not displayed or used in boxplot values
(Five at pre-inf 1)
0
56
47
47
32
34
Pre Inf 1
Day 7
Day 30
Month 6
Year 1
Follow-Up
Values greater than 400 mg/dL are not displayed or used in boxplot values
(Tw o at pre-inf 1)
Percent of Recipients with Fasting Blood Glucose  126 mg/dL
Post Last Infusion by Insulin Status
B. Islet After Kidney Recipients
100
100
90
90
80
80
70
70
Percent of Recipients
Percent of Recipients
A. Islet Alone Recipients
60
50
40
30
60
50
40
30
20
20
10
10
0
Pre Infusion 1
N=0:320
Insulin Status
Month 6
N=171:126
Year 1
N=137:142
Year 2
N=90:139
Independent
Year 3
N=54:119
Year 4
N=23:91
Dependent
0
Pre Infusion 1
N=0:56
Insulin Status
Month 6
N=33:22
Year 1
N=23:30
Year 2
N=12:29
Independent
Year 3
N=4:31
Year 4
N=3:19
Dependent
Composite Outcome (Hypoglycemia and HbA1C) Post Last Infusion
A. Islet Alone Recipients
80
70
Percent of Recipients
60
50
40
30
20
10
0
Pre Infusion 1
N=347
Day 30
347
Month 6
314
Year 1
298
Year 2
266
Year 3
216
No severe hypoglycemic episodes and HbA1c < 6.5%
No severe hypoglycemic episodes and 6.5% <= HbA1c < 7.0%
Severe hypoglycemic episode or HbA1c >= 7.0% with detectable fasting c-peptide
Severe hypoglycemic episode or HbA1c >= 7.0% without detectable fasting c-peptide
Missing data for recipient with islet graft failure
Other missing data
Year 4
155
Composite Outcome (Hypoglycemia and HbA1C) Post Last Infusion
B. Islet After Kidney Recipients
80
70
Percent of Recipients
60
50
40
30
20
10
0
Pre Infusion 1
N=65
Day 30
65
Month 6
63
Year 1
59
Year 2
49
Year 3
42
No severe hypoglycemic episodes and HbA1c < 6.5%
No severe hypoglycemic episodes and 6.5% <= HbA1c < 7.0%
Severe hypoglycemic episode or HbA1c >= 7.0% with detectable fasting c-peptide
Severe hypoglycemic episode or HbA1c >= 7.0% without detectable fasting c-peptide
Missing data for recipient with islet graft failure
Other missing data
Year 4
35
Severe Hypoglycemia
A. Post First Infusion (Censored at Re-Infusion before Visit)
Islet Alone Recipients
100
90
Percent of Recipients
80
70
60
50
40
30
20
10
0
Pre Inf 1
N=347
Month 6
N=152
No severe hypoglycemic episodes
Severe hypoglycemic episode
Missing data for recipient with islet graft failure
Other missing data
Year 1
N=112
Severe Hypoglycemia
B. Post First Infusion (Censored at Re-Infusion before Visit)
Islet After Kidney Recipients
100
90
Percent of Recipients
80
70
60
50
40
30
20
10
0
Pre Inf 1
N=65
Month 6
N=24
No severe hypoglycemic episodes
Severe hypoglycemic episode
Missing data for recipient with islet graft failure
Other missing data
Year 1
N=16
Severe Hypoglycemia
C. Post Last Infusion
Islet Alone Recipients
100
90
Percent of Recipients
80
70
60
50
40
30
20
10
0
Pre Inf 1
N=347
Day 30
N=347
Month 6
N=314
Year 1
N=298
Year 2
N=266
No severe hypoglycemic episodes
Severe hypoglycemic episode
Missing data for recipient with islet graft failure
Other missing data
Year 3
N=216
Year 4
N=155
Severe Hypoglycemia
D. Post Last Infusion
Islet After Kidney Recipients
100
90
Percent of Recipients
80
70
60
50
40
30
20
10
0
Pre Inf 1
N=65
Day 30
N=65
Month 6
N=63
Year 1
N=59
Year 2
N=49
No severe hypoglycemic episodes
Severe hypoglycemic episode
Missing data for recipient with islet graft failure
Other missing data
Year 3
N=42
Year 4
N=35
Severe Hypoglycemia
E. Post Last Infusion
Islet Alone Recipients with Detectable Fasting C-peptide
100
90
Percent of Recipients
80
70
60
50
40
30
20
10
0
Pre Inf 1
N=65
Day 30
N=325
Month 6
N=278
Year 1
N=237
Year 2
N=170
Severe hypoglycemic episode
Missing data
Year 3
N=114
Year 4
N=68
Severe Hypoglycemia
F2.(Subset of F1): Islet Alone Recipients with
No Detectable Fasting C-peptide or Known Graft Loss and
Known Information on Occurrence of Severe Hypoglycemic Episodes
Post Last Infusion
100
100
90
90
80
80
70
70
Percent of Recipients
Percent of Recipients
F1. All Islet Alone Recipients with
No Detectable Fasting C-peptide or Known Graft Loss
Post Last Infusion
60
50
40
30
60
50
40
30
20
20
10
10
0
Pre Inf 1
N=260
Day 30
N=22
Month 6
N=39
Year 1
N=54
Year 2
N=81
Severe hypoglycemic episode
Missing data
No severe hypoglycemic episode
Year 3
N=76
Year 4
N=67
0
Pre Inf 1
N=354
Day 30
N=20
Month 6
N=32
Year 1
N=29
Year 2
N=38
Severe hypoglycemic episode
No severe hypoglycemic episode
Year 3
N=22
Year 4
N=13
Hypoglycemia Status Pre First Infusion and
Post Last Infusion
All Allograft Recipients
70
Per cent of Reci pi ent s
60
50
40
30
20
10
0
Pr e I nf 1
N=412
Mont h 6
N=377
Year 1
N=357
Year 2
N=315
Year 3
N=258
No hypogl ycemi c epi sodes
Havi ng epi sodes and awar e
Par t i al awar eness
Hypogl ycemi a unawar eness
Mi ssi ng dat a f or r eci pi ent wi t h i sl et gr af t f ai l ur e
Ot her mi ssi ng dat a
Year 4
N=190
HbA1C
A. Post First Infusion (Censored at Re-Infusion before Visit)
Islet Alone Recipients
80
70
Percent of Recipients
60
50
40
30
20
10
0
Pre Inf 1
N=347
Month 6
152
HbA1c < 6.5%
6.5% <= HbA1c < 7.0%
HbA1c >= 7.0%
Missing data for recipient with islet graft failure
Other missing data
Year 1
112
HbA1C
A. Post First Infusion (Censored at Re-Infusion before Visit)
Islet After Kidney Recipients
80
70
Percent of Recipients
60
50
40
30
20
10
0
Pre Inf 1
N=65
Month 6
24
HbA1c < 6.5%
6.5% <= HbA1c < 7.0%
HbA1c >= 7.0%
Missing data for recipient with islet graft failure
Other missing data
Year 1
16
HbA1C
B. Post Last Infusion
Islet Alone Recipients
80
70
Percent of Recipients
60
50
40
30
20
10
0
Pre Inf 1
N=347
Month 6
314
Year 1
298
Year 2
266
Year 3
216
HbA1c < 6.5%
6.5% <= HbA1c < 7.0%
HbA1c >= 7.0%
Missing data for recipient with islet graft failure
Other missing data
Year 4
155
HbA1C
B. Post Last Infusion
Islet After Kidney Recipients
80
70
Percent of Recipients
60
50
40
30
20
10
0
Pre Inf 1
N=65
Month 6
63
Year 1
59
Year 2
49
Year 3
42
HbA1c < 6.5%
6.5% <= HbA1c < 7.0%
HbA1c >= 7.0%
Missing data for recipient with islet graft failure
Other missing data
Year 4
35
HbA1C (%)
Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
12.5
12.5
10.0
10.0
%
%
A. Islet Alone Recipients
7.5
5.0
2.5
7.5
5.0
329
225
82
291
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
275
231
180
116
Year 1
Year 2
Year 3
Year 4
Follow-Up
2.5
59
47
12
55
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
51
42
35
23
Year 1
Year 2
Year 3
Year 4
Follow-Up
HbA1C (%) Pre and Post First Infusion
Insulin Independent Recipients
B. Islet After Kidney Recipients
12.5
12.5
10.0
10.0
%
%
A. Islet Alone Recipients
7.5
5.0
5.0
2.5
7.5
329
29
138
142
Pre Inf 1
Day 30
Month 6
Year 1
Follow-Up
2.5
59
4
Pre Inf 1
Day 30
22
17
Month 6
Year 1
Follow-Up
HbA1C (%) Pre and Post First Infusion
Insulin Dependent Recipients
B. Islet After Kidney Recipients
12.5
12.5
10.0
10.0
%
%
A. Islet Alone Recipients
7.5
5.0
5.0
2.5
7.5
329
178
145
138
Pre Inf 1
Day 30
Month 6
Year 1
Follow-Up
2.5
59
24
30
30
Pre Inf 1
Day 30
Month 6
Year 1
Follow-Up
Recipients with HbA1C < 6.5%
Percent of Post Last Infusion by Insulin Status
A. Islet Alone Recipients
100
90
Percent of Recipients
80
70
60
50
40
30
20
10
0
Pre Infusion 1
N=0:329
Insulin Status
Month 6
N=169:120
Year 1
N=135:138
Year 2
N=88:137
Independent
Year 3
N=54:119
Year 4
N=23:90
Dependent
Complications of Diabetes
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Autonomic Neuropathy
100
100
80
80
Percent of Recipients
Percent of Recipients
Peripheral Neuropathy
60
40
20
0
60
40
20
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=383
N=263
N=216
N=147
N=96
N=52
Disabling
Symptomatic
Asymptomatic
None
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=371
N=266
N=216
N=144
N=96
N=53
Disabling
Symptomatic
Asymptomatic
None
Complications of Diabetes (continued)
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Coronary Artery Disease
100
100
80
80
Percent of Recipients
Percent of Recipients
Nefropathy
60
40
20
60
40
20
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=380
N=280
N=236
N=151
N=93
N=54
Stable Allograft
ESRD
Macroalbuminuria
Microalbuminuria
None
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=386
N=276
N=230
N=154
N=104
N=54
Yes
No
Complications of Diabetes (continued)
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Peripheral Vascular Disease
100
100
80
80
Percent of Recipients
Percent of Recipients
Stroke
60
40
40
20
20
0
60
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=373
N=275
N=231
N=152
N=104
N=54
Yes
No
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=367
N=273
N=226
N=152
N=101
N=54
Yes
No
Complications of Diabetes (continued)
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Foot Ulcers
100
100
80
80
Percent of Recipients
Percent of Recipients
Treated Hypertension
60
40
40
20
20
0
60
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=387
N=295
N=248
N=157
N=104
N=56
Yes
No
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=347
N=275
N=229
N=151
N=104
N=55
Yes
No
Complications of Diabetes (continued)
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Foot Deformity
100
100
80
80
Percent of Recipients
Percent of Recipients
Lower Limb Amputation
60
40
20
0
60
40
20
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=379
N=283
N=237
N=155
N=105
N=58
Yes
No
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=354
N=278
N=230
N=154
N=105
N=57
Yes
No
Complications of Diabetes (continued)
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Orthostatic Hypotension
100
100
80
80
Percent of Recipients
Percent of Recipients
Dysesthesia
60
40
40
20
20
0
60
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=350
N=262
N=219
N=145
N=99
N=51
Yes
No
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=316
N=246
N=212
N=133
N=97
N=53
Yes
No
Complications of Diabetes (continued)
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Constipation
100
100
80
80
Percent of Recipients
Percent of Recipients
Gastroparesis
60
40
40
20
20
0
60
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=342
N=267
N=223
N=140
N=99
N=51
Yes
No
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=340
N=270
N=228
N=147
N=99
N=51
Yes
No
Complications of Diabetes (continued)
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Fecal Incontinence
100
100
80
80
Percent of Recipients
Percent of Recipients
Diabetic Diarrhea
60
40
40
20
20
0
60
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=345
N=257
N=220
N=145
N=99
N=52
Yes
No
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=342
N=268
N=228
N=149
N=100
N=53
Yes
No
Complications of Diabetes (continued)
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Sexual Dysfunction
100
100
80
80
Percent of Recipients
Percent of Recipients
Diabetic Bladder Dysfunction
60
40
20
0
60
40
20
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=341
N=268
N=226
N=144
N=99
N=52
Yes
No
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=316
N=233
N=200
N=124
N=85
N=44
Yes
No
Complications of Diabetes (continued)
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Diabetic Macular Edema
100
100
80
80
Percent of Recipients
Percent of Recipients
Retinopathy
60
40
20
0
60
40
20
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=376
N=239
N=190
N=114
N=80
N=43
Proliferative
Non Proliferative
None
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=352
N=238
N=189
N=114
N=83
N=38
Severe
Moderate
Mild
None
Complications of Diabetes (continued)
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Laser Photocoagulation Surgery for
Diabetic Macular Edema
100
100
80
80
Percent of Recipients
Percent of Recipients
Laser Photocoagulation Surgery for
Proliferative Retinopathy
60
40
20
0
60
40
20
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=372
N=287
N=241
N=153
N=105
N=55
Yes
No
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=357
N=287
N=241
N=153
N=105
N=54
Yes
No
Complications of Diabetes (continued)
Pre First Infusion and Post Last Infusion
All Allograft Recipients with Documented Graft Function
Other Eye Surgery
100
100
80
80
Percent of Recipients
Percent of Recipients
Vtirectomy
60
40
20
0
60
40
20
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=379
N=287
N=241
N=153
N=105
N=54
Yes
No
0
Pre Inf 1
Month 6
Year 1
Year 2
Year 3
Year 4
N=366
N=287
N=241
N=154
N=105
N=54
Yes
No
Chapter 6: Liver, Kidney, Lipid and PRA
Effects
ALT (IU/L) Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
150
150
125
125
100
100
IU/L
IU/L
A. Islet Alone Recipients
75
75
50
50
25
25
0
307
211
70
234
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
193
128
79
45
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 150 IU/L are not displayed or used in boxplot values
(Tw o at pre-inf 2, one at month 6, one at year 1, and one at year 2)
0
57
49
13
52
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
46
34
27
15
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 150 IU/L are not displayed or used in boxplot values
(One at pre-inf 2, one at month 6, and one at year 2)
AST (IU/L) Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
120
120
100
100
80
80
IU/L
IU/L
A. Islet Alone Recipients
60
60
40
40
20
20
0
320
233
77
272
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
229
148
95
51
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 120 IU/L are not displayed
(One at pre-inf 1, one at pre-inf 2, one at month 6, one at year 1, and one at year 2)
0
58
49
12
52
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
46
34
27
15
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 120 IU/L are not displayed
(One at month 6, and one at year 2)
Alkaline Phosphatase (IU/L) Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
350
350
300
300
250
250
200
200
IU/L
IU/L
A. Islet Alone Recipients
150
150
100
100
50
50
0
317
229
75
260
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
229
144
95
50
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 350 IU/L are not displayed
(Tw o at pre-inf 2, one at month 6, one at year 1, and one at year 2)
0
56
49
12
48
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
46
34
27
15
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 350 IU/L are not displayed
(Four at pre-inf 1, four at pre-inf 2, tw o at year 1, and one at year 2)
Total Bilirubin (mg/dL) Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
3.5
3.5
3.0
3.0
2.5
2.5
2.0
mg/dL
mg/dL
A. Islet Alone Recipients
1.5
1.5
1.0
1.0
0.5
0.0
2.0
0.5
319
221
75
251
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
214
145
94
48
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 3.5 mg/dL are not displayed
(One at pre-inf 1 and one at year 1)
0.0
57
47
13
45
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
45
34
26
13
Year 1
Year 2
Year 3
Year 4
Follow-Up
Total Cholesterol (mg/dL) Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
350
350
300
300
250
250
mg/dL
mg/dL
A. Islet Alone Recipients
200
200
150
150
100
100
50
50
0
327
196
69
248
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
230
152
98
49
Year 1
Year 2
Year 3
Year 4
Follow-Up
0
56
39
9
48
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
43
34
28
15
Year 1
Year 2
Year 3
Year 4
Follow-Up
HDL (mg/dL) Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
200
200
150
150
mg/dL
mg/dL
A. Islet Alone Recipients
100
50
0
100
50
319
179
59
228
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
218
139
93
47
Year 1
Year 2
Year 3
Year 4
Follow-Up
0
49
28
5
35
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
34
27
24
11
Year 1
Year 2
Year 3
Year 4
Follow-Up
LDL (mg/dL) Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
300
300
250
250
200
200
mg/dL
mg/dL
A. Islet Alone Recipients
150
150
100
100
50
50
0
313
178
57
225
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
214
138
92
47
Year 1
Year 2
Year 3
Year 4
Follow-Up
0
47
28
5
35
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
34
27
24
11
Year 1
Year 2
Year 3
Year 4
Follow-Up
Triglycerides (mg/dL) Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
450
450
400
400
350
350
300
300
mg/dL
mg/dL
A. Islet Alone Recipients
250
250
200
200
150
150
100
100
50
50
0
327
194
69
246
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
229
150
98
50
Year 1
Year 2
Year 3
Year 4
Follow-Up
0
55
39
9
48
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
43
34
27
14
Year 1
Year 2
Year 3
Year 4
Follow-Up
Serum Creatinine (mg/dL) Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
4.0
4.0
3.5
3.5
3.0
3.0
2.5
2.5
mg/dL
mg/dL
A. Islet Alone Recipients
2.0
2.0
1.5
1.5
1.0
1.0
0.5
0.5
0.0
338
234
78
280
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
243
169
104
56
Year 1
Year 2
Year 3
Year 4
Follow-Up
0.0
62
48
14
54
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
49
34
28
16
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 4.0 mg/dL are not displayed
(Tw o at pre-inf 1, one at month 6 and one at year 2)
Percent of Recipients with a 30% Increase in Serum Creatinine
at Each Follow-up Time Point
B. Islet After Kidney Recipients
100
100
80
80
Percent of Recipients
Percent of Recipients
A. Islet Alone Recipients
60
40
40
20
20
0
60
Month 6
Year 1
Year 2
Year 3
Year 4
N=277
N=240
N=167
N=103
N=55
>=30% Increase In Serum Creatinine
<30% Increase In Serum Creatinine
0
Month 6
Year 1
Year 2
Year 3
Year 4
N=52
N=47
N=34
N=27
N=15
>=30% Increase In Serum Creatinine
<30% Increase In Serum Creatinine
Cockgroft-Gault Calculated Creatinine Clearance (mL/min/1.73m2)
Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
250
250
200
200
mL/min/1.73m2
mL/min/1.73m2
A. Islet Alone Recipients
150
100
50
0
150
100
50
271
114
35
146
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
146
66
39
19
Year 1
Year 2
Year 3
Year 4
Follow-Up
0
42
18
5
22
Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6
27
19
15
10
Year 1
Year 2
Year 3
Year 4
Follow-Up
“Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated GFR (mL/min/1.73m2)
Pre Infusion and Post Last Infusion
B. Islet After Kidney Recipients
180
180
150
150
ml/min/1.73 m2
ml/min/1.73 m2
A. Islet Alone Recipients
120
90
120
90
60
60
30
30
0
338
234
78
280
243
169
104
56
Pre Inf 1
Pre Inf 2
Pre Inf 3
Month 6
Year 1
Year 2
Year 3
Year 4
Follow-Up
Values greater than 180 ml/min/1.73 m2 are not displayed or used in boxplot values
(One at pre-inf 1 and one at pre-inf 3)
0
60
47
14
53
48
34
28
16
Pre Inf 1
Pre Inf 2
Pre Inf 3
Month 6
Year 1
Year 2
Year 3
Year 4
Follow-Up
Class I PRA (%)
Pre Infusion and Post Last Infusion
Islet Alone Recipients
100
90
80
70
%
60
50
40
30
20
10
0
303
Pre Inf 1
206
Pre Inf 2
73
200
174
135
Pre Inf 3
Month 6
Year 1
Year 2
Follow-Up
98
Year 3
63
Year 4
% Change in Class I PRA from Pre First Infusion
Pre Subsequent Infusion and Post Last Infusion
Islet Alone Recipients
Change from Pre Infusion 1
100
75
50
25
0
-25
203
Pre Inf 2
71
199
Month 6
173
134
Year 2
Follow-Up
Values less than -25 are not displayed
(One at pre-inf 3 and one at year 1)
96
63
Year 4
Class I PRA Post Last Infusion
Islet Alone Recipients with Complete Graft Loss
100
90
80
70
%
60
50
40
30
20
10
0
11
Month 6
15
26
18
Year 1
Year 2
Year 3
Follow-Up
9
Year 4
Class I PRA Post Last Infusion
Islet Alone Recipients without Complete Graft Loss
100
90
80
70
%
60
50
40
30
20
10
0
189
Month 6
159
109
80
Year 1
Year 2
Year 3
Follow-Up
54
Year 4
Class I PRA Post Last Infusion
Non-Immunosupressed Islet Alone Recipients
100
90
80
70
%
60
50
40
30
20
10
0
4
Month 6
7
12
7
Year 1
Year 2
Year 3
Follow-Up
3
Year 4
Class I PRA Post Last Infusion
Immunosupressed Islet Alone Recipients
100
90
80
70
%
60
50
40
30
20
10
0
191
Month 6
164
119
87
Year 1
Year 2
Year 3
Follow-Up
57
Year 4
Chapter 7: Adverse Events
Percent of Recipients with an Adverse Event (AE) or Serious Adverse Event (SAE)
in Year 1 Post First Infusion
Total Number of Adverse Events and Serious Adverse Events
in Year 1 Post First Infusion
IA: Incidence of Post-Transplant Adverse Events Related to Infusion Procedure
IAK: Incidence of Post-Transplant Adverse Events
Related to Infusion Procedure
IA: Incidence of Post-Transplant Adverse Events Related to Immunosupression Therapy
Follow-up Based on Completed Scheduled Visits
IAK: Incidence of Post-Transplant Adverse Events Related to Immunosupression Therapy
Follow-up based on completed scheduled visits
Percent of Recipients with a Serious Adverse Event
in Year 1 Post First Infusion by Year of First Infusion
All Allograft Recipients
60
Percent of Recipients
50
40
30
20
10
0
1999-2000
N=19
2001-2002
N=115
2003-2004
N=100
2005-2006
N=111
2007-2008
N=67
Year of First Infusion
Any SAE
SAE related to either the infusion procedure or immunosuppression
SAE related to the infusion procedure
SAE related to immunosuppression
Serious Adverse Event Criteria by Relatedness to Islet Infusion or Immunosuppression
Outcome of Serious Adverse Events by Relatedness to Islet Infusion or Immunosuppression
Serious Adverse Events MedDRA System/Organ Class
by Relatedness to Islet Infusion or Immunosuppression
Serious Adverse Events MedDRA System/Organ Class
by Relatedness to Islet Infusion or Immunosuppression (continued)
Most Common Serious Adverse Events
MedDRA Preferred Term
Islet Alone Recipients
Most Common Serious Adverse Events
MedDRA Preferred Term
Islet After Kidney Recipients
Most Common Serious Adverse Events Reported
Within One Year of Any Infusion
MedDRA Preferred Term
All Allograft Recipients
Most Common Serious Adverse Events Reported
More than One Year after Any Infusion
MedDRA Preferred Term
All Allograft Recipients
Listing of Reported Neoplasms
All Allograft Recipients
Listing of Reported Neoplasms (continued)
All Allograft Recipients
Listing of Reported Neoplasms (continued)
All Allograft Recipients
Listing of Reported Hemorrhages and Portal Vein Thromboses
All Allograft Recipients
Listing of Reported Hemorrhages and Portal Vein Thromboses (continued)
All Allograft Recipients
Listing of Reported Hemorrhages and Portal Vein Thromboses (continued)
All Allograft Recipients
Listing of Reported Hemorrhages and Portal Vein Thromboses (continued)
All Allograft Recipients
Number of Days Hospitalized at Infusion (from Admission to Discharge)
by Infusion Sequence
Islet Alone Recipients
20
Number of Days
15
10
5
0
330
233
75
1
2
3
Infusion Sequence
Values greater than 20 days are not displayed
(Three at infusion 1 and one at infusion 3)
Number of Days Hospitalized at Infusion (from Admission to Discharge)
by Infusion Sequence
Islet After Kidney Recipients
20
Number of Days
15
10
5
0
62
47
13
1
2
3
Infusion Sequence
Values greater than 20 days are not displayed
(Three at infusion 1 and one at infusion 3)
Hospitalization Experienced Post Last Infusion by Total Number of Infusions Received
Islet Alone Recipients
Hospitalization Experienced Post Last Infusion by Total Number of Infusions Received
Islet After Kidney Recipients
Chapter 8: Registry Data Quality Review
Expected and Submitted Forms by Infusion Sequence
Expected and Submitted Follow-Up Forms Post Last infusion
All Allograft Recipients
Extent of Follow-Up Post Last Infusion
All Allograft Recipients
Appendices
CITR Coordinating Center
(July 2008 – July 2009)
PI: Franca Benedicty Barton
Co-PI: Donald Stablein
Yamini Babu
Ruth Danoff
Jodi DeStefano
Andrew Heitman
Krista Huang
Steve Wease
Tina Winters
Islet Transplant Centers
Baylor College of Medicine/
The Methodist Hospital
Houston, Texas, USA
PI: John A. Goss
Baylor Regional Transplant Institute
Dallas, Texas, USA
PI: Marlon Levy
Benaroya Research Institute
Seattle, Washington, USA
PI: Carla Greenbaum
Carolinas Medical Center
Charlotte, North Carolina, USA
PI: Paul Gores
Center for Islet Transplantation at
Harvard Medical School
Boston, Massachusetts, USA
PI: Enrico Cagliero
Columbia University
New York, New York, USA
PI: Mark A. Hardy
Emory Transplant Center
Atlanta, Georgia, USA
PI: Mark Rigby
GenevaGRAGIL Network
Geneva, Switzerland
PI: Thierry Berney
Lille University Hospital
Lille Cedex, France
PI: Francois Pattou
Mayo Clinic
Rochester, Minnesota, USA
PI: Yogish Kudva
NIH Clinical Transplant Center
Bethesda, Maryland, USA
PI: David Harlan
Northwestern University
Chicago, Illinois, USA
PI: Dixon Kaufman
San Raffaele Institute
Milan, Italy
PI: Antonio Secchi
Scripps Health
La Jolla, California, USA
PI: Christopher Marsh
The University of Tennessee,
Memphis
Memphis, Tennessee, USA
PI: A. Osama Gaber
University of Miami
Miami, Florida, USA
PI: Rodolfo Alejandro
Co-PI: Camillo Ricordi
UMass Memorial Hospital
Worcester, Massachusetts, USA
PI: Aldo Rossini
University of Minnesota
Minneapolis, Minnesota, USA
PI: Bernhard J. Hering
University of Alabama
Birmingham, Alabama, USA
PI: Juan Luis Contreras
University of Nebraska
Omaha, Nebraska, USA
PI: R. Brian Stevens
University of Alberta
Edmonton, Alberta, CANADA
PI: A. M. James Shapiro
Co-PI: Peter Senior
Parastoo Dinyari
University of Pennsylvania
Philadelphia, Pennsylvania, USA
PI: Ali Naji
University of Virginia
Charlottesville, Virginia, USA
PI: Kenneth Brayman
Southern California Islet Consortium
(SCIC)
Duarte, California, USA
PI: Fouad Kandeel
University of California,
San Francisco
San Francisco, California, USA
PI: Peter Stock
Co-PI: Andrew Posselt
St. Vincent’s Institute
Fitzroy, Victoria, Australia
PI: Tom Kay
University of Chicago
Chicago, Illinois, USA
PI: Marc Garfinkel
Virginia Commonwealth University
Richmond, Virginia, USA
PI: Adrian Cotterell
Swedish Medical Center
Seattle, Washington, USA
PI: William Marks
University of Colorado Health
Sciences Center
Auora, Colorado, USA
PI: Alexander Wiseman
University of Pennsylvania
Washington University,
St. Louis
St. Louis, Missouri, USA
PI: Niraj Desai
Toronto General Hospital
Toronto, Ontario, CANADA
PI: Mark Cattral
University of Illinois, Chicago
Chicago, Illinois, USA
PI: Jose Oberholzer
Co-PI: Enrico Benedetti
Co-PI: James Bui
Co-PI: Charles Owens
University of Wisconsin
Madison, Wisconsin, USA
PI: Jon Odorico
Westmead Hospital
Wentworthville, NSW, Australia
PI: Philip Oconnell
CITR Committees
Scientific Advisory Committee (SAC)
Compliance Committee (2008)
Data Elements Committee (2008)
Publications/Presentations Committee (2008)
Transplant Coordinators’/Data Managers’ Committee (2008)
CITR Scientific Advisory Committee (SAC)
Chair: Bernhard J. Hering
Michael Appel
Franca Benedicty Barton
Michael Cecka
Philip E. Cryer
Olle Korsgren
Maureen McBride
Jerry P. Palmer
Camillo Ricordi
Gordon Weir
CITR Compliance Committee (2008)
Chair: Fouad Kandeel
Michael Appel
Parastoo Dinyari
Albert Hwa
Carol Kramer
Joan Martellotto
Violetta Raverdi
Marti Sears
Elyse Stuart
CITR Data Elements Committee (2008)
Chair: Marti Sears
David Baidal
Enrico Cagliero
Marc Garfinkel
Fouad Kandeel
Dixon Kaufman
Robert Ketchum
Francois Pattou
David Sutherland
CITR Publications/Presentations Committee (2008)
Chair: Rodolfo Alejandro
Michael Appel
Nancy Bridges
Shari Messinger Cayetano
Brian Flanagan
Elizabeth Holbrook
Robert Ketchum
Bashoo Naziruddin
Craig Smith
CITR Transplant Coordinators’/
Data Managers’ Committee (2008)
Chair: Parastoo Dinyari
Robin Jevne
Nancy Radke
Jarrett Anderson
Jenny Joseph
Violeta Raverdy
David Baidal
Debra Kemp
Marilyn Reeve
LeAnn Batterson
Mark Lockwood
Kristi Schneider
Meyer Belzer
Eileen Markmann
Marti Sears
Elsa Boely
Joan Martellotto
Jill Sheedy
Jane Fasbender
Marli McCulloch-Olson
KD Shiang
Courtney Garbee
Joan McElroy
Elyse Stuart
Susan George
Melissa McGraw
Pat Swanson
Debbie Grice
Suzanne Miller
Heather Turgeon
Darrell Grimes
Bashoo Naziruddin
Patricia Wilson
Jeannette Hacker
Lori Otken
Dona Winborne
Celia Hartigan
Maral Palanjian
Piotr Witkowski
Elizabeth Holbrook
Jamen Parkey
CITR Allografts
Recipients with C-Peptide ≥ 0.3 Pre-Infusion