Mesenchymal Stem Cell Therapy for Inflammatory Bowel Disease: A Systematic Review and Meta-analysis
Maneesh Dave, M.B.B.S., M.P.H. 1, Kathan Mehta, M.B.B.S., M.P.H.2, Jay Luther, MD3, Anushka Baruah, M.B.B.S4, Allan B Dietz PhD 5,
William A. Faubion, Jr., M.D.6
1
Division of Gastroenterology & Liver Disease, Case Western Reserve University, University Hospitals Case Medical Center, Cleveland, Ohio,
USA; 2Division of Internal Medicine, University of Pittsburgh Medical Centre Shadyside Hospital, Pennsylvania; 3 Division of Gastroenterology
& Hepatology, Massachusetts General Hospital, Boston, Massachusetts, USA; 4Division of Internal Medicine, John Stroger Hospital of Cook
County, Chicago, Illinois, USA; 5 Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA; 6 Division of
Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Word count:
Abstract: 122;
Manuscript including the abstract, figure and table legends: 5903 words.
Correspondence:
Maneesh Dave, Division of Gastroenterology & Liver Disease, University Hospitals Case Medical Center, 11100 Euclid Avenue, Cleveland,
OH-44106, USA. Tel: 216-844-1995; Fax: 216-844-7371; E-mail: maneesh.dave@uhhospitals.org
William A Faubion, M.D., Division of Gastroenterology and Hepatology, Guggenheim 10, 200 1st St. SW, Rochester, MN 55905, USA. Tel:
507-284-2468; Fax: 507-255-6318; E-mail: faubion.william@mayo.edu
Supplementary table 2: Clinical trials studying role of stem cell therapy in treatment of Inflammatory Bowel Diseases (clincaltrials.gov)
Name of Study
Treatment of Fistulous Crohn's Disease by Implant of Autologous
Mesenchymal Stem Cells Derived From Adipose Tissue
Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment
of Moderate-to-severe Crohn's Disease
Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula
(ALLO-ASC)
Evaluation of PROCHYMAL® Adult Human Stem Cells for
Treatment-resistant Moderate-to-severe Crohn's Disease
Safety and Efficacy of Adipose-Derived Stem Cells to Treat
Complex Perianal Fistulas Patients With Crohn's Disease (FATT)
Allogenic Stem Cells Derived From Lipoaspirates for the Treatment
of Recto-vaginal Fistulas Associated to Crohn`s Disease
(ALOREVA)
Mesenchymal Stem Cell Therapy for the Treatment of Severe or
Refractory Inflammatory and/or Autoimmune Disorders
Transplantation of Bone Marrow Mesenchymal Stem Cell in
Crohn's Disease
Extended Evaluation of PROCHYMAL[tm] Adult Human Stem
Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
Dose-escalating Therapeutic Study of Allogeneic Bone Marrow
Derived Mesenchymal Stem Cells for the Treatment of Fistulas in
Patients With Refractory Perianal Crohn's Disease
Safety and Efficacy Study of Autologous Cultured Adipose Derived Stem Cells for the Crohn's Fistula
Safety and Efficacy Study of Autologous Cultured Adipose Derived Stem Cells for the Crohn's Fistula
Type of
Study
Location
Type of
Stem Cells
Source of
Stem
Cells
Mode of
delivery
Status
Adipose
tissue
Local
implant
Ongoing,
but not
recruiting
Bone
marrow
Adipose
tissue
Systemic
infusion
Local
injection
Bone
marrow
Systemic
infusion
Recruiting
Adipose
tissue
Local
injection
Terminated
Adipose
tissue
Local
injection
Completed
Bone
marrow
Bone
marrow
Bone
marrow
Systemic
infusion
Local
injection
Systemic
infusion
Bone
marrow
Local
injection
Adipose
tissue
Adipose
tissue
Local
injection
Local
injection
1/2
Spain
Autologous
2
United States
Allogeneic
1
Korea
Allogeneic
3
3
United States,
Australia, Canada, Allogeneic
New Zealand
Austria,
Autologous
Netherlands, Spain
1/2
Spain
Allogeneic
1/2
Belgium
Allogeneic
1
Iran
Autologous
3
United States,
Canada
Allogeneic
1/2
Netherlands
Allogeneic
1
Korea
Autologous
2
Korea
Autologous
Completed
Unknown
Recruiting
Recruiting
Completed
Recruiting
Completed
Completed
3
Austria, Belgium,
France, Germany,
Israel, Italy,
Netherlands, Spain
Allogeneic
Adipose
tissue
Local
injection
Recruiting
Study to Assess the Safety and Efficacy of Expanded Allogenic
Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of
Complex Perianal Fistulas in Perianal Crohn's Disease.
1/2a
Spain
Allogeneic
Adipose
tissue
Local
injection
Completed
Safety and Efficacy of FURESTEM-CD Inj. in Patients With
Moderately Active Crohn's Disease(CD)
1/2a
Korea
Allogeneic
Umbilical
cord blood
Local
injection
Not yet
open for
recruitment
3
United States,
Australia, New
Zealand
Allogeneic
Bone
marrow
Systemic
infusion
Recruiting
2
Korea
Autologous
2
Korea
Autologous
Stem Cell Fistula Plug in Perianal Crohn's Disease (MSC-AFP)
1
United States
Autologous
Bone Marrow Stromal Cells for Inflammatory Bowel Diseases
1
United States
Allogeneic
Adipose
tissue
Adipose
tissue
Adipose
tissue
Bone
marrow
Local
injection
Local
injection
Fistula
plug
Systemic
infusion
A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation
Study to Determine the Safety and Efficacy of Intravenous Infusion
of Human Placenta-Derived Cells (PDA001) for the Treatment of
Crohn's Disease
1
United States
Allogeneic
Human
Placenta
Systemic
infusion
Follow-up Study of Autologous Adipose-derived Stem Cells
(ANTG-ASC) for the Complex Fistula (ANTG-ASC-211)
2
Korea
Autologous
Adipose
tissue
Local
injection
Not
provided
United States
Allogeneic
Bone
marrow
Systemic
infusion
1/2
Netherlands
Allogeneic
Bone
marrow
Local
injection
Ongoing
3
Spain
Allogeneic
Adipose
tissue
Local
injection
Ongoing
Adipose Derived Mesenchymal Stem Cells for Induction of
Remission in Perianal Fistulizing Crohn's Disease (ADMIRE-CD)
Evaluation of PROCHYMAL® for Treatment-refractory Moderateto-severe Crohn's Disease
Follow-up Study of Autologous Cultured Adipose-derived Stem
Cells for the Crohn's Fistula (ANTG-ASC-203)
Clinical Trials of Autologous Cultured Adipose-derived Stem Cells
(ANTG-ASC) on Complex Fistula (ANTG-ASC-210)
Safety and Treatment Outcome Study of PROCHYMAL®
(Remestemcel-L) Intravenous Infusion in Subjects With Treatmentresistant Crohn's Disease
Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the
Treatment of Fistulas in Patients with Refractory Perianal Crohn’s
Disease
Study to assess efficacy and safety of stem cells derived from
allogeneic adipose tissue for the treatment of perianal fistulas in
Unknown
Unknown
Recruiting
Recruiting
Recruiting
Ongoing,
but not
recruiting
Ongoing,
but not
recruiting
patients with Crohn’s disease.
A prospective study for the assessment of the long-term safety and
efficacy of Cx401 in patients taking part in the FATT2 trial.
3
Spain
Autologous
FATT 2: Fistula Advanced Therapy Trial (II)
3
Spain
Autologous
Adipose
tissue
Adipose
tissue
Local
injection
Local
injection
Completed
Ongoing