MATERNAL BLOOD, UMBILICAL CORD BLOOD STEM CELLS AND / OR PLACENTAL TISSUE ALLOGRAFTS
TESTING, PROCESSING, STORAGE, EXPANSION, RETRIEVAL AND INFORMED CONSENT AGREEMENT
I, Archana Kumari along with my spouse Mr.Santosh Kumar (the 'Client') (bearing CRM: 210003500012 ), on behalf of myself/ourselves and
my/our unborn Child (the 'Child'), engage LifeCell International Private Limited, a company incorporated under the Companies Act, 1956, having
CIN U85196TN2004PTC053577 and having its registered office at No. 26, Vandalur Kelambakkam Main Road, Keelakottaiyur, Chennai 600127, Tamil Nadu, India ('LifeCell'), on this day of 29-01-2021 (the 'Enrollment Date'), to test, process, store, expand and retrieve stem cells
obtained from the Umbilical Cord Blood and/or test, process and release placental tissue allografts collected at childbirth, and to test the
Maternal Blood collected from the Birth Mother ('Services') on the following terms (this 'Agreement').
1.
DEFINITIONS
In this Agreement (including the recitals above), unless the
context otherwise requires, the following expressions shall
have the following meanings:
1.1.
'Caregiver' means the Obstetrician/Gynecologist and/or
qualified medical professional/midwife who will be assisting
in delivering the Child.
1.2.
'Child' means the Client's baby (or babies in the event of
multiple births) from whom the Umbilical Cord Blood will be
collected following his/her birth.
1.3.
'Client' means the biological parents or legal guardian of the
Child or the Child after attaining the age of majority.
1.4.
'Collection Kit' means a UN 3373 certified kit, compliant with
International Air Transport Association (IATA) regulations,
consisting of all essential materials required for the purpose
of collection and labelling of the Maternal Blood and
Umbilical Cord Blood.
1.5.
'Maternal Blood' means the peripheral blood collected from
the Birth Mother of the Child, which has been drawn by
observing standard phlebotomy procedures taken within
seven days before or after the birth of the Child.
1.6.
'Umbilical Cord Blood' means the blood inside the umbilical
cord and/or placenta.
1.7.
'Private Banking' means a program wherein Client banks
their Child's Specimen for exclusive usage by the Child
and/or Child's biological sibling/s and/or Child's biological
parent/s and/or Child's biological grandparent/s, as
applicable.
1.9.
1.10. 'Registry' means and includes listing of HLA (Human
Leukocyte Antigen) typing results of Umbilical Cord Blood
Specimens
that meet specific
qualifying
criteria
(benchmarked against international guidelines) that may
preclude it from being eligible for utilization in stem cell
transplantation, including but not limited to cell counts,
microbial contamination, pre-existing condition/s like
hemoglobinopathies, infectious diseases, etc.
1.11. 'Colony Forming Unit (CFU) Assay' is a qualitative and
quantitative method, by which the proof of 'multipotency and
proliferation capacity,' the most vital property of a stem cell, is
assessed. This shows the capacity of a single stem cell, not
only to differentiate into specialized cellular lineages (cell
potency) but also ensure proliferation to an acceptable
number of each of the specialized cell types.
1.12. 'Viability' denotes the percentage of alive (viable) stem cells
present in the Umbilical Cord Blood which is capable of
engraftment.
1.13. 'Mesenchymal Stromal Cells / Stem Cells (MSC's)' are
stem cells that are plastic-adherent when maintained in
standard culture conditions, they express cell surface
molecules/markers like CD105, CD73 and CD90, and lack
expression of CD45, CD34, CD14, CD19 and HLA-DR and
also differentiate to osteoblasts, adipocytes and
chondroblasts in vitro.
'Specimen' means and includes banked or cryopreserved
stem cells obtained from the Umbilical Cord Blood, unless
specifically mentioned otherwise.
1.8.
second birth anniversary of the Child. As per clause 7.2, the
Client can also retrieve the Specimen/s of other LifeCell
Community Banking Program Clients.
'Community Banking' means a program wherein Client
banks the Child's Umbilical Cord Blood Specimen for nonexclusive usage, wherein the Client also agrees to donate
their Child's Umbilical Cord Blood Specimen for usage by
other LifeCell Community Banking Program Clients after the
1.14. 'Human Leukocyte Antigen (HLA)' are proteins or markers
found on most cells in the body, and are used by the immune
system to differentiate between one's own cells and others.
HLA typing is used to match patients and donors for bone
marrow or peripheral blood or umbilical cord blood stem cell
transplants.
1.15. 'Inherited
Diseases Testing' is a next generation
sequencing (NGS) based test that searches for variations in
the coding regions of genes known to cause rare inherited
diseases of pediatric-onset.
1.16. 'Pediatric Cancer Profiling' is a next generation sequencing
(NGS) based test for comprehensive genomic profiling of all
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |
forms of childhood cancer, including but not limited to
leukemia, brain tumors, and a diverse group of solid tumors.
1.17. 'Allograft' means aseptically processed human allogeneic
placental tissue allograft (also known as Amchoplast) which
retains the structural properties of the extracellular matrix
aided with multiple protein molecules, cytokines,
chemokines and growth factors that triggers accelerated
chronic wound healing process in a natural way.
2.
SERVICES: OPTION AND FEES
2.1.
Lifecell offers its Umbilical Cord Blood Stem Cell Banking
Services under different plans, fees and payment methods
as detailed in the Plan and Payments section, which the
Client must choose at the time of Enrollment.
2.2.
All applicable taxes including but not limited to Goods and
Services Tax, present and/or future levy, if any, are payable
by the Client.
3.
CLIENT RESPONSIBILITIES
3.1.
Client is responsible for providing the Collection Kit to the
Caregiver and arranging for collection, preparation and
labelling of the Maternal Blood and the Umbilical Cord Blood
for delivery to LifeCell's laboratory along with the duly filled
up forms included in the Collection Kit, unless otherwise
specified by the Client to LifeCell for assistance as per
Clause 8.9.
3.2.
Client must promptly notify LifeCell in writing regarding any
change in Client's name or contact details (including but not
limited to mailing address, telephone numbers, email id, etc.)
or any change in the legal guardianship of the Child.
3.3.
In the case of retrieval of Specimen/s and/or expanded
MSC’s for any approved stem cells transplant/s and/or
approved clinical trial/s and/or Placental Tissue Allograft/s,
as applicable, the Client has to submit duly filled up
Retrieval Form provided by LifeCell at relevant time (to be
accompanied by patient's transplant physician's certificate
confirming end use in statutorily compliant approved
transplant procedures or approved clinical trial/s). relevant
time (to be accompanied by patient's transplant physician's
certificate confirming end use in statutorily compliant
approved transplant procedures or approved clinical trial/s).
4.
STORAGE
4.1.
LifeCell assures to process the Umbilical Cord Blood
Specimen by using its personalized PrepaCyte-CB®
processing technology involving red blood cell reduction
and plasma depletion and store it in vapor phase of liquid
nitrogen in special cryo-bags compartmentalized in volumes
of 5 mL and 20 mL along with attached test segments (6
segments of 0.2 mL each). LifeCell shall also store some
portion of the Maternal Blood in special cryo-vials, in case
needed, for future testing requirements.
4.2.
For disaster management and added retention security,
LifeCell has its licensed facilities situated at No. 26,
Vandalur Kelambakkam Main Road, Keelakottaiyur,
Chennai - 600127, Tamil Nadu, India and Plot No. 26, Sector
4, IMT Manesar, Gurugram - 122001, Haryana, India.
LifeCell will store the entire Specimen at either of its licensed
facilities, at its own discretion, hereby known as the Dual Site
Facility.
4.3.
For the purpose of safety, LifeCell has the option to relocate
the entire stored Specimen or a part of the same at its own
cost to a comparable stem cell bank facility and will provide
Notice to the Client within 14 days of such relocation. In case
of any planned relocation, LifeCell will provide Notice to the
Client within 14 days of such relocation.
5.
TERM OF AGREEMENT
5.1
If the Client chooses the Annual Storage Plan, this
Agreement term will continue and shall be held as valid for
one year from the date of birth of the Child ('Renewal Date')
and will automatically renew for successive one year period
until the survival of the Child and Child's biological parents
and Child's biological siblings (if any), whichever is later.
This automatic renewal is subject to the Client paying the
annual storage fees to LifeCell on or before the Renewal
Date every year.
5.2.
Client may opt for prepayment of the storage fees and
upgrade their Annual Storage Plan to OneTime Plan or
LifeTime Plan, or upgrade their OneTime Plan to LifeTime
Plan by paying the applicable fees as advised by LifeCell at
relevant time. Upon such payment, the Annual Storage Plan
will be converted to OneTime Plan or LifeTime Plan, or the
OneTime Plan will be converted to LifeTime Plan and this
Agreement term will be extended to twenty one years or
seventy five years respectively from the date of birth of the
Child until the survival of the Child and the Child's biological
parents and Child's biological siblings (if any), whichever is
later.
5.3.
At least 90 days before the expiration of this Agreement term,
LifeCell shall notify the Client (or the Child on attaining the
age of majority) regarding the expiry of this Agreement,
along with the terms of continued storage. Accordingly, the
Client (or the Child on attaining the age of majority) can
enter into a new Agreement and continue the storage of the
Specimen.
6.
REPRESENTATIONS AND WARRANTIES OF CLIENT
Client represents and warrants that:
6.1.
She/he is the parent or legal guardian of the Child.
6.2.
Client has had the opportunity to read, understand, review
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |
and consult with the Client's own legal counsel and medical
professional, this entire Agreement, informed consents,
possible risks of collection, processing, storage and possible
future use of the Maternal Blood and Specimen/s.
6.3.
The decision to collect the Umbilical Cord Blood, Maternal
Blood and/or Placental Tissues, test the Maternal Blood, and
test, process, store, expand and retrieve the Specimen/s
and/or Placental Tissue Allograft/s is a completely voluntary
act of the Client.
7.
LIFECELL COMMUNITY BANKING PROGRAM
Client understands that for treatment of majority of the
medical condition/s, the Child's own Umbilical Cord Blood
Specimen may not be the preferred choice for stem cell
transplant (in the opinion of the patient's transplant
physician) and could therefore require Specimen/s from
matching unrelated donor/s. In order to maximize the
chances of finding such suitable matching Specimen/s, the
Client can benefit from the LifeCell Community Banking
Program subject to conditions, which are detailed below:
7.1.
Agreement, and retrieve the Child's own stored Specimen
and/or matching unrelated Umbilical Cord Blood Specimen/s
including for medical condition/s diagnosed prior to the
Enrollment Date, for use by the Child and/or Child's
biological sibling/s and/or Child's biological parent/s and/or
Child's biological grandparent/s for any stem cell transplant/s
or clinical trial/s approved by national or international
regulatory health bodies as applicable. Client is required to
fulfill the Qualifying Criteria as per Clause 7.1 to become part
of the LifeCell Community Banking Program. LifeCell
assures that for accessions and retrievals of matching
unrelated Umbilical Cord Specimens from the LifeCell
Registry there would be no extra cost and also no restriction
on the number of matching Specimens that can be retrieved
by the LifeCell Community Banking Program Client.
7.3.
the Child's Umbilical Cord Blood Specimen for stem cell
transplant by other listed LifeCell Community Banking
Program Client, LifeCell shall notify the donor Client within
30 days after such release. As a goodwill gesture in
recognition of the Client's contribution in facilitating this
transplant, LifeCell shall refund all past fees paid by the
Client to LifeCell (except Sample Collection Charges), waive
all future fees, and also provide continuity of benefits
available under the LifeCell Community Banking Program
and LifeCell Client Benefit Programs as applicable until
seventy five years from the date of birth of the Child.
Qualifying Criteria for Community Banking Program
Client to Access LifeCell Registry:
a. the Client provides Maternal Blood sample of sufficient
quality and quantity within seven days before or after
childbirth;
7.4.
c. The Client submits the duly filled Infant Health History
Questionnaire and signed by a registered medical
practitioner;
d. the Client consents without any reservations to release
their Child's Umbilical Cord Blood Specimen after the
second birth anniversary of the Child to other listed LifeCell
Community Banking Client as the need arises;
f. Even if the LifeCell Community Banking Program Client's
Umbilical Cord Blood Specimen does not meet specific
qualifying criteria (benchmarked against international
guidelines) for listing in LifeCell Registry, the Client shall
continue to enjoy all the benefits under the LifeCell
Community Banking Program and the LifeCell Client Benefit
Programs.
7.2.
Retrieval for Stem Cells Transplant: LifeCell Community
Banking Clients can access the LifeCell Registry after the
Enrollment Date (even during the initial first two years from
date of birth of the Child) and during the entire tenure of this
Transfer to Private Banking Program: Clients opting for
the LifeCell Community Banking Program can at any time,
prior to the Child's Umbilical Cord Blood Specimen being
reserved for transplant release, elect on their own volition to
irrevocably switch to the LifeCell Private Banking Program.
Also, Umbilical Cord Blood Specimens that do not meet the
qualifying criteria for LifeCell Registry accession as per
Clause 7.1 would be moved to the LifeCell Private Banking
Program. However, in the event the Child is diagnosed of
medical condition/s that may require the use of Child's own
Umbilical Cord Blood Specimen, the Client may exclusively
reserve the Child's own Specimen without exiting the
LifeCell Community Banking Program by providing
documentary evidence from the treating transplant physician
to LifeCell.
b. The Client submits the duly filled Maternal Health History
Questionnaire;
e. the Client has not on their own volition elected to
irrevocably switch over to LifeCell Private Banking Program.
Release Notification & Goodwill Benefit: Upon release of
7.5.
LIFECELL PRIVATE BANKING PROGRAM
Clients opting for this program will be able to exercise
exclusive control of their Child's Umbilical Cord Blood
Specimen. However, they may not be able to access the
LifeCell Community Banking Program Registry should there
be a subsequent need for stem cells from unrelated donor/s.
In the event of the Child's own Specimen being required for
the Child and/or Child's biological sibling/s and/or Child's
biological parent/s and/or Child's biological grandparent/s,
the same can be retrieved by the Client at no additional
costs for any stem cell transplant/s or any clinical trial/s
approved by national or international regulatory health
bodies as applicable.
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |
8.
LIFECELL CLIENT BENEFIT PROGRAMS
confirmed by the patient's transplant physician, LifeCell at no
additional cost to the Client shall provide the expansion of
hematopoietic stem cells derived from Umbilical Cord Blood
Specimen/s based on LifeCell's in-house protocols
becoming commercially available in future and subjected to
applicable approvals by local and national regulatory
authorities.
In order to provide a comprehensive coverage for the Child
and/or Child's biological sibling/s and/or Child's biological
parent/s and/or Child's biological grandparent/s as
applicable, LifeCell through its Client Benefit Programs
provides additional guarantees, assistance and benefits
which are detailed below:
8.4.
8.1.
Entitlement to Full Refund: LifeCell understands that the
the completion of the Child's twenty first birth anniversary,
the Child and/or Child's biological sibling/s and/or Child's
biological parent/s are diagnosed of medical condition/s
treatable using MSC’s in approved transplantation/s or
approved clinical trial/s, as confirmed by the patient's
transplant physician, LifeCell at no additional cost to the
Client shall provide upto 1 billion ready-to-use allogeneic
MSC's within 7 days, either by Drugs Controller General of
India (DCGI) and/or The Central Drugs
life and health of the Mother and Child are the utmost
priority. Hence, in rare circumstances, if the Umbilical Cord
Blood is not collected for any reason including this priority or
in an unfortunate situation of non-survival of the Child at
birth, LifeCell shall refund all fees paid by the Client to
LifeCell upon sharing of relevant declaration from the
attending gynecologist.
8.2.
Medical Treatment Assistance for Hematopoietic Stem
Cells Transplantation: If after the Enrollment Date and
before the completion of the Child's twenty first birth
anniversary, the Child and/or Child's biological sibling/s
and/or Child's biological parent/s are diagnosed of medical
condition/s treatable using the Child's own Specimen and/or
matching unrelated Umbilical Cord Blood Specimen/s from
the LifeCell Registry (applicable only to LifeCell Community
Banking Clients) through an approved hematopoietic stem
cell transplantation, then LifeCell shall pay the Client as per
actual expenses or ₹2,000,000 (INR Two Million only)
whichever is lesser in order to offset the costs of such
transplantation. In the unfortunate scenario that the Child's
own Specimen and/or Umbilical Cord Blood Specimen/s
listed on the LifeCell Community Banking Registry
(applicable only to LifeCell Community Banking Clients) is
either no longer available and/or not a suitable match to the
patient for stem cell transplant (in the opinion of the patient's
transplant physician), then LifeCell will source alternative
matching Umbilical Cord Blood Specimen/s from any public
stem cell bank worldwide within 14 days for value not
exceeding ₹2,000,000 (INR Two Million only). In case if the
matching Umbilical Cord Blood Specimen/s is not found in
any public stem cell banks worldwide, then in order to
support transplantation from any other approved stem cell
sources (like bone marrow or peripheral blood), LifeCell
shall pay as per actual expenses or ₹2,000,000 (INR Two
Million only) whichever is lesser, to the Client, in order to
offset the costs of such stem cells transplantation.
8.3.
Standard Control Organisation (CDSCO) and/or Indian
Council of Medical Research (ICMR) approved, allogeneic
expanded mesenchymal stromal cells / stem cells, ready-touse cryopreserved product, derived from donated adult
human bone marrow or allogeneic MSC's derived from
Wharton's Jelly of voluntarily donated human Umbilical Cord
Tissue manufactured based on LifeCell's in-house protocols
subjected to applicable approvals by local and national
regulatory authorities.
8.5.
Free Worldwide Shipment: Upon submission of duly filled
Retrieval Form by the Client (as provided by LifeCell at
relevant time) for retrieval of Specimen/s and/or expanded
MSC’s and/or Placental Tissue Allograft/s for any approved
transplant/s or approved clinical trial/s, LifeCell at no
additional cost to the Client shall make the same available
for delivery within 7 days. LifeCell shall also arrange and
pay for transport of the same under cryogenic conditions, to
the transplant center located at any destination within India
or worldwide. LifeCell shall also assist the Client in
procuring any regulatory clearances / permissions required
for the transportation of the Specimen/s and/or expanded
MSC’s for any approved stem cells transplant/s or approved
clinical trial/s.
8.6.
Medical
8.7.
Quality
Free Umbilical Cord Blood Stem Cells Expansion: If after
the Enrollment Date and before the completion of the Child's
twenty first birth anniversary, the Child and/or Child's
biological sibling/s and/or Child's biological parent/s are
diagnosed of medical condition/s treatable using the Child's
own Specimen and/or matching unrelated Umbilical Cord
Blood Specimen/s from the LifeCell Registry (applicable only
to LifeCell Community Banking Clients) through an
approved transplantation/s or approved clinical trial/s and
should cellular expansion of the Umbilical Cord Blood
Specimen/s be deemed necessary for such transplant, as
Free Guaranteed Mesenchymal Stromal/Stem Cells
(MSC’s) Expansion: If after the Enrollment Date and before
Concierge: As added assistance for enabling
approved stem cells transplant/s or approved clinical trial/s,
LifeCell shall provide all medical and travel information
including leading transplant physicians, approved and
credible medical transplant institutions at no additional cost
to the Client.
Guarantee: If in the opinion of the patient's
transplant physician should for any reason the Specimen/s
upon retrieval for hematopoietic stem cell transplantation
does not meet then prevailing viability and/or potency criteria
benchmarked against international best practices, then
LifeCell shall pay ₹2,000,000 (INR Two Million only) to the
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |
Client if it is unable to source matching Umbilical Cord Blood
Specimen/s from any public stem cell bank worldwide and/or
from the LifeCell Registry (applicable only to LifeCell
Community Banking Clients) within 14 days for a value not
exceeding ₹2,000,000 (INR Two Million only).
8.8.
within 30 days either to the Client or on behalf of Client to the
patient's stem cells transplant center (as per the Client's
choice ), upon appropriate verification of Client's request.
c. The benefits available under the applicable LifeCell Client
Benefit Programs are valid for every stem cell
transplantation. Either upon retrieval of the entire stored.
Specimen/s from the LifeCell Registry (applicable only to
LifeCell Community Banking Clients) and/or upon providing
replacement Umbilical Cord Blood Specimen/s from any
public stem cell bank worldwide and/or from the LifeCell
Registry (applicable only to LifeCell Community Banking
Clients) and/or on making the due Payment to full extent to
the Client by LifeCell, as applicable under the LifeCell Client
Benefit Program/s, the Client would release LifeCell from
any further obligations related to this specific stem cells
transplantation.
Disaster Relief: Should for any unforeseen reason, that is
beyond the reasonable control of LifeCell, which may
potentially deteriorate or cause loss, harm and damage,
entirely or partly, of the Umbilical Cord Blood and/or
Specimen/s, during transit, processing and/or storage, and
upon Specimen/s and/or expanded MSC's being required for
stem cells transplant is unfit and/or insufficient, then LifeCell
shall pay ₹2,000,000 (INR Two Million only) to the Client if it
is unable to source expanded MSC's or matching Umbilical
Cord Blood Specimen/s from any public stem cell bank
worldwide and/or from the LifeCell Registry (applicable only
to LifeCell Community Banking Clients) within 14 days for a
value not exceeding ₹2,000,000 (INR Two Million only).
8.9.
d. Clauses 8.2, 8.3 and 8.4 are applicable after the
Enrollment Date and till the completion of the Child's twenty
first birth anniversary. All the other LifeCell Client Benefit
Programs mentioned in Clause 8 shall be applicable during
the entire tenure of this Agreement, as per the plan chosen
by the Client.
Sample Collection and Transport Assistance: At the
request of the Client and upon payment of applicable fees,
LifeCell would arrange for a certified and trained paramedic
for the collection of the Maternal Blood and Umbilical Cord
Blood, and/or a certified service provider for transport of the
Maternal Blood and Umbilical Cord Blood to LifeCell's
Laboratory, provided however that the Client provides
reasonable time to LifeCell for allowing the paramedic to
reach the birthing center i.e. not less than two hours prior to
childbirth for a birthing center located within 50 km radius of
nearest LifeCell Service Center, and not less than 8 hours
for further away locations.
8.10. Storage Fee Waiver: In case of unfortunate demise or
permanent physical disability of either of the Client during
the minority of the Child, LifeCell would refund the prepaid
storage fees on a pro-rata basis and shall continue storage
of the Specimen at LifeCell's own cost till the Child attains
the age of majority.
9.
During the entire tenure of this Agreement, LifeCell hereby
assures the Client that:
9.1.
LifeCell has all statutory permissions and licenses that are
required for providing the Services contemplated under this
Agreement
9.2.
LifeCell shall provide the Client with the following
immediately upon Enrollment: copy of this Agreement and
formal e-receipt, a unique Client Relationship Management
(CRM) number that enables the Client to quote for all
communications with LifeCell and unique login ID and
password to access the Client portal on LifeCell’s website.
Sample collection kit box will be delivered in the Client's
place after enrollment. Client is requested to read through
the kit box handling instructions which forms part of the
enrollment email with LifeCell.
9.3.
LifeCell upon receipt of the Maternal Blood and Umbilical
Cord Blood at its laboratory would determine whether it is fit
or unfit for testing, processing and/or storage.
9.4.
In rarely occurred circumstances, if the Child's Umbilical
Cord Blood is of insufficient volume and/or is unfit for
processing and/or storage, LifeCell shall notify the Client
and discard the Specimen after receiving a written consent
from the Client. However, if LifeCell does not receive a
written consent within 30 days of such notification, LifeCell
shall continue storing the Specimen. In such an event, the
Client shall continue to enjoy the benefits under the LifeCell
Community Banking Program and the LifeCell Client Benefit
Programs as long as the entire applicable fees are paid to
LifeCell by the Client.
8.11. Free Allografts
(Applicable only to LifeCell Client
Voluntarily Donating The Child’s Placental Tissues): If
after the Enrollment Date and before the completion of the
Child's twenty first birth anniversary, the Child and/or Child's
biological sibling/s and/or Child's biological parent/s are
diagnosed of medical condition/s treatable using Placental
Tissue Allograft/s in approved transplantation/s or approved
clinical trial/s, as confirmed by the patient's transplant
physician, LifeCell at no additional cost to the Client shall
make two allografts (of any available size / form as
requested by the patient’s physician) available for delivery
within 7 days.
8.12. General Conditions for LifeCell Client Benefit Programs:
a. This Client Agreement is valid and is in force.
b. The Payments as specified and applicable under the
LifeCell Client Benefit Program shall be made by LifeCell
LIFECELL ASSURANCES
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |
9.5.
As per the statutory regulations, if the Maternal Bloodis not
provided within 7 days before or after childbirth , the Child's
Specimen can be used only for autologous purposes.
9.6.
The Specimens and/or Placental Tissue Allografts would be
tested, processed, stored, expanded and retrieved (as
applicable) in accordance to approved Standard Operating
Procedures and in compliance with statutory regulations.
9.7.
Upon successful collection, processing, testing and storage,
LifeCell will provide the Client with a Preservation Certificate
confirming storage of the Specimen along with sample
storage details and test results within 45 days of receipt of
the Maternal Blood and Umbilical Cord Blood at LifeCell's
laboratory.
9.8.
LifeCell shall at its own discretion never subject the
Specimens to any unauthorized usage and/or donate it for
research and/or therapeutic purposes unless this Agreement
is terminated as per clause 12.1 (d).
9.9.
Upon submission of the duly filled Specimen Search
Request Form by the Client (as provided by LifeCell at
relevant time), a search shall be commissioned in the
LifeCell Registry for the LifeCell Community Banking Clients
and results shall be provided within 4 days.
10.2. LifeCell disclaims any responsibility to provide any other
Services (except those specified in this Agreement ) and
third party service providers like Caregiver, Transporter, etc.
shall have the respective responsibility for their services
including any loss, harm, damage, delay in delivery, etc.
10.3. Client agrees that LifeCell's liability for any loss, harm,
damage or claim of any kind in connection with this
Agreement or Services provided by LifeCell and/or third
party service providers shall be limited to the return of an
amount equal to all fees paid by the Client or benefits
available under the applicable LifeCell Client Benefit
Programs as per Clause 8 (whichever is higher). However,
for any act/s committed by LifeCell that are intentional and/or
grossly negligent, this liability shall be subject to the
discretion of the Court of Law.
11.
FORCE MAJEURE
Client agrees that LifeCell's liability for causes and/or
circumstances which are beyond LifeCell's reasonable
control shall be limited to that committed under 'Disaster
Relief' Program.
12.
TERMINATION OF AGREEMENT
12.1. This Agreement may be terminated
9.10. During the entire term of this Agreement, on every birth
anniversary of the Child, LifeCell hereby assures to send an
Annual Preservation Status Report on the most updated
registered Email ID of the Client, which shall contain monthly
temperature data of the cryo-chambers in which the Child’s
Specimen is being stored that is recorded automatically from
our highly advanced temperature monitoring software,
thereby assuring the Client that the Child’s Specimen is
safely stored in accordance to approved Standard Operating
Procedures and in compliance with statutory regulations.
9.11. During the entire term of this Agreement, at the time of
retrieval for every stem cell transplantation, LifeCell shall
perform at no additional cost to the Client, genetic tests like
Inherited Diseases Testing and Pediatric Cancer Profiling on
the Child's own stored Specimen and/or matching unrelated
Umbilical Cord Blood Specimen/s from LifeCell’s Registry
and/or matching Umbilical Cord Blood Specimen/s from any
public stem cell bank worldwide (as confirmed by the
patient's transplant physician).
9.12. As per the voluntary consent from the Client, LifeCell shall at
its own discretion shall release the Placental Tissue for
research, therapeutic and/or commercial purposes.
10.
DISCLAIMER & LIMITATIONS:
10.1. LifeCell does not perform any medical Services, give any
medical advice, or otherwise perform any Services other
than those expressly indicated in this Agreement. It disclaims
all other representations, guarantees, warranties or
assurances express or implied.
a. by Client at any time prior to the Umbilical Cord Blood
collection, or
b. by Client at any time after storage of the Specimen, or
c. by Client on their own will if they do not wish to continue
storage of the Child's Specimen, including the consequential
act of sample rejection as per clause 9.4, or
d. by LifeCell if any payment due to LifeCell during the entire
term of this Agreement is not timely paid by the Client and
such failure to pay is not cured within 30 days from the due
date of such payment, without prejudice to LifeCell's right to
take legal steps to recover the debt, or
e. by mutual agreement of Client and LifeCell, or
f. by either party upon 60 days prior written Notice to the
other party hereto, or
g. in the event the entire Specimen is retrieved for stem cell
transplantation (applicable only to LifeCell Private Banking
Program Clients). However, if the Client retrieves only a
portion of the Specimen, this Agreement would survive along
with all benefits for the entire term of this Agreement.
h. in the event either law or a governmental agency or
regulatory provisions or medical guidelines requires LifeCell
to terminate this Agreement.
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |
12.2. Effects of Termination:
a. If this Agreement is terminated under Section 12.1. (a), all
fees paid by the Client shall be refunded after deducting a
cancellation fee of ₹7,500 (INR Seven Thousand Five
Hundred only).
b. If this Agreement is terminated under Section 12.1. (b), all
fees paid by the Client are non-refundable. The Client
reserves the right to shift the Child's Specimen at their own
cost to any other stem cell bank facility of their choice.
Client at time of Enrolment to execute all rights of the Child's
biological mother as stated in this Agreement.
14.
All disputes arising out of or relating to this Agreement will
be resolved by arbitration. The arbitration will take place in
Chennai, Tamil Nadu, India and the language shall be
English. The arbitration will be governed by the Arbitration
and Conciliation Act, 1996, as amended from time to time.
15.
c. If this Agreement is terminated under Section 12.1. (c) or
12.1.(h), the Storage and/or Processing fees would be
refunded, as applicable.
d. If this Agreement is terminated under Section 12.1.(d), the
Client relinquishes all rights in and to the Child's Specimen
and waives all claims to the Child's Specimen and LifeCell
shall have the right to discard and/or donate the Child's
Specimen at its sole discretion. However, LifeCell shall
continue storing this Specimen with no liabilities to the Client
for a period of two years from the date of termination of this
Agreement. Client can revive this Agreement within this
grace period of two years by paying the applicable storage
fee along with a late fee of ₹5,000 (INR Five Thousand only)
if the payment is paid after 30 days as mentioned in Clause
12.1.d.
e. If this Agreement is terminated by LifeCell under Section
12.1.(f), LifeCell hereby assures that it will at its own cost
arrange for transfer of the Child's Specimen to a comparable
stem cell bank facility and also pay this new stem cell bank
for storing the Child's Specimen for the remaining term of this
Agreement. Thereupon, all the benefits available under the
LifeCell Client Benefit Programs under clause 8 of this
Agreement shall automatically survive for the remaining term
of this Agreement. If this Agreement is terminated by the
Client under Section 12.1.(f), the Client shall bear the entire
cost for shifting the Child's Specimen to another stem cell
bank facility of their own choice.
f. If this Agreement is terminated under Sections 12.1.(e) or
12.1.(g) a prorated refund of the prepaid Storage fees will be
made by LifeCell to the Client. If this Agreement is
terminated by the Client under Sections 12.1.(e) or 12.1.(g),
the Client shall bear the entire cost for shifting of the Child's
Specimen to another stem cell bank facility of their own
choice.
g. All payments and refunds by LifeCell shall be processed
within 30 days of receiving the complete documentation from
the Client.
13.
SURROGACY
In case of surrogate births, the Child's biological mother's
health history shall be duly filled and submitted by the Client
to LifeCell. The Child's non-birth mother shall register as
ARBITRATION
GOVERNING LAW AND JURISDICTION
This Agreement is governed by, construed and interpreted in
accordance with the laws of India. Courts in Chennai , Tamil
Nadu, India, shall have exclusive jurisdiction.
16.
CONFIDENTIALITY; CONSENT TO RELEASE
LifeCell acknowledges the confidential nature of the
information provided to it and agrees to use its best efforts to
maintain the confidentiality of the information except as
required by law or as permitted by this Agreement. All
confidential information and personal identifiable information
shall be kept on a secure database with adequate backup
measures. Client and, if different, the Birth Mother of the
Child hereby agrees to the release of information to the
hospital, laboratory or physician providing the Services to
the Client.
17.
MULTIPLE BIRTHS
In the event of multiple births, if the Client desires to engage
LifeCell for its Services, for each Child, at the time of
Enrollment the Client must check the appropriate box in the
birthing section and pay the relevant additional fees to
LifeCell..
18.
ASSIGNMENT
18.1. LifeCell may assign this Agreement to any individual or
entity providing similar service. If LifeCell is acquired by or
merged with or into another Company, LifeCell shall require
that the terms of this Agreement continue in full force and
effect. LifeCell shall notify the Client within 90 days in the
event of any such assignment.
18.2. The Client shall have all the rights over this Agreement until
the Child attains the age of majority , further to which all the
rights over this Agreement shall be automatically transferred
to the Child. The Client undertakes to inform the Child
promptly of his/her rights with regards to the Child's
Specimen on the Child attaining the age of majority,
including the right to renew this Agreement. In an
unfortunate situation of non-survival of the Child after
attaining the age of majority, all the rights over this
Agreement shall be automatically transferred to the Child's
biological parents and Child's biological siblings, if any. If
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |
there is any disagreement between the Child's parents, the
Child's Mother's wish shall prevail.
19.
Agreements or understandings, oral and/or written. This
Agreement may be modified only by written Agreement of
the Client and the Authorised Signatory of LifeCell who has
signed in this Agreement and such modifications thereupon
shall supersede any prior Agreements or understandings,
oral and/or written and shall constitute as a part of this entire
Agreement.
NOTICE
19.1. Notice to LifeCell must be in writing and delivered to LifeCell
International
Private
Limited, No. 26, VandalurKelambakkam Main Road, Keelakottaiyur, Chennai 600127, Tamil Nadu, India.
21.
All provisions which by their terms require performance after
the termination of this Agreement will survive even after the
termination of this Agreement.
19.2. Notice to Client or legal guardian will be in writing and
delivered to the address set forth in the Enrollment section or
as last updated by Client to LifeCell.
20.
ENTIRE AGREEMENT
This Agreement including the Exhibits, sections on the Risks
Relating to Stem Cell Banking, List of the Tests Performed,
Maternal Health History, Infant Health History and the
Informed Consents hereto constitute this entire Agreement
between LifeCell and the Client and supersede any prior
SURVIVAL
22.
SEVERABILITY
If any part of this Agreement is found to be invalid or
unenforceable, such provision will be deemed modified to
the extent necessary to make the Agreement enforceable,
and this Agreement shall otherwise remain in full force and
effect.
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |
EXHIBIT 1: CONSENT OF NON-CLIENT BIRTH MOTHER FOR COLLECTION
The Birth Mother of the Child has reviewed this Agreement, and hereby acknowledges and agrees that she is not the legal guardian of the Child, is not a party to
this Agreement, and is not a third-party beneficiary of this Agreement. Birth Mother hereby waives, releases and abandons any and all rights or entitlement to the
Maternal Blood, Umbilical Cord Blood, Specimen and/or Placental Tissues. Birth Mother consents and agrees to the testing of the Maternal Blood as referenced in
this Agreement and consents and agrees to the release of the test results to the Client. Birth Mother agrees she has no right to enforce any term, condition/s or
provision of this Agreement, or to exercise any right of the Client under this Agreement. Birth Mother acknowledges that she has been fully informed of the
procedures associated with cellular donation and the alternatives to cellular donation and accepts and agrees to the benefits, limitations, risks, and discomfort of
cellular donation and has had the opportunity to access donor advocacy service. Birth Mother has been given the opportunity to ask questions and had those
questions answered satisfactorily. Birth Mother assumes all risks associated with the collection of Maternal Blood, Umbilical Cord Blood, and/or Placental
Tissues.
EXHIBIT 2: INFORMED CONSENT TO INFECTIOUS DISEASE AND HIV TESTING
LifeCell requires infectious disease testing to be performed on the Maternal Blood obtained from the birthing mother of the Child that includes but not limited to HIV
testing, in conjunction with the processing of Umbilical Cord Blood and/or Placental Tissues. The Maternal Blood sample must be drawn at the time of delivery
independent of previous infectious disease and/or HIV testing which may have been done during pregnancy. In the event of Maternal Blood found to be unfit or
insufficient or not provided, LifeCell will notify the Client immediately and seek another collection. As per the statutory regulations, if the Maternal Blood is not
provided within 7 days before or after childbirth, the Child's Specimen can be used only for autologous purposes. The Client also understands that some portion
of the Maternal Blood would be stored in special cryo-vial, in case needed, for future testing requirements. The Birth Mother of the Child hereby acknowledges
and agrees that she is aware that her peripheral blood will be screened for transfusion transmitted infections. The screening procedure involves testing of her
blood for Syphilis, Hepatitis B, Hepatitis C, HIV, HTLV I & II, Cytomegalovirus, and Malaria, etc. as mentioned in the list of tests performed. If any of these tests is
positive, a confirmatory test is performed at no additional cost to the Client, by a qualified external agency and only if this confirmatory test is positive, then further
course is decided with counseling. The results will not be disclosed to any other party without Client’s consent, except to the extent disclosure is required by law.
EXHIBIT 3: AUTHORIZATION TO COLLECT UMBILICAL CORD BLOOD AND/OR PLACENTAL TISSUES: RELEASE FROM LIABILITY
The Client hereby declares that he/she is aware about the collection of Umbilical Cord Blood and Placental Tissues at the time of birth of the Child. Consent is
hereby granted by the Client to the medical professionals attending to the birth of the Child to perform this collection. The Client acknowledges that complications
may occur during such collection which could prevent or impede the collection of Umbilical Cord Blood and Placental Tissues or produce an inadequate
Specimen. The Client further acknowledges that medical judgment, with the best interest of the Mother and Child in mind, could totally prevent the collection. The
Client hereby releases and forever discharges LifeCell, the Caregiver, the obstetrician gynaecologist or certified nurse midwife, the hospital or birthing center, and
their respective officers, directors, shareholders, employees, agents, representatives, affiliates, successors and assigns (collectively, the "Released Parties") of
and from any and all liability for any and all loss, harm, damage or claim of any kind arising from or relating to the collection of, or failure to collect, the Umbilical
Cord Blood and Placental Tissues. The Client acknowledges that, by this release, the undersigned is giving up any right she may otherwise have, now or in the
future, to sue or otherwise seek monetary damages or other relief against any of the Released Parties for any reason relating to the collection of, or failure to
collect, the Umbilical Cord Blood and Placental Tissues.
EXHIBIT 4: AUTHORIZATION TO RELEASE SPECIMEN FOR AN UNRELATED STEM CELL TRANSPLANT
(Applicable only to LifeCell Community Banking Clients)
The Client having understood the risks, benefits, and alternatives for the Child, hereby gives consent to release the Umbilical Cord Blood Specimen of the Child to
another matched and unrelated LifeCell Community Banking Program Client as and when required. Information related to the Child and Client shall remain
confidential and is only available for review by individuals designated by LifeCell or by quality and statutory authorities as necessary to evaluate the operations.
Client also agrees that he / she has voluntarily elected to come under the LifeCell Community Banking Program and the option of transferring the Umbilical Cord
Blood Specimen to Private Banking Program was provided by LifeCell at time of Enrollment and until their Child's Umbilical Cord Blood Specimen was reserved for
stem cell transplant by other LifeCell Community Banking Program Client.
In the event that their Child's Umbilical Cord Blood Specimen becomes a match to another LifeCell Community Banking Program Client, and the same is retrieved
and used in a transplant, the Child's own Umbilical Cord Blood Specimen shall not be available for the Child and/or its immediate family's use. There may be
scenarios where the Client is unable to find suitably matching Specimen/s in the LifeCell Registry, as finding a suitably matching unrelated Umbilical Cord Blood
Specimen/s depends on the number of Specimens stored from the same geographical and ethnic background of the patient. In such scenarios, an additional
search in the inventories of public stem cell banks worldwide shall be made and suitably matching Specimen/s shall be provided if available as per the terms of
this Agreement. Also, the Client understands that autologous stem cells could be harvested from bone marrow or peripheral blood when needed for a stem cell
transplant.
EXHIBIT 5: AUTHORIZATION TO PERFORM INHERITED DISEASES TESTING AND PEDIATRIC CANCER PROFILING TEST BEFORE
RELEASE OF SPECIMEN FOR STEM CELL TRANSPLANT
(Applicable only to LifeCell Community Banking Clients)
The Client hereby acknowledges that he/she is aware about the Next-Generation Sequencing (NGS) based Inherited Diseases Testing and Pediatric Cancer
Profiling test that shall be performed on the Child’s Specimen, which is HLA matched to a patient before the release of the Specimen for stem cell transplantation.
This test shall be used to identify if the matched Specimen is carrying any genetic mutation(s) which may cause a specific disease or medical condition and helps
the patient’s transplant physician to take an informed decision on the use of such Specimen. The results of this test shall not be disclosed to any other party
without Client’s consent, except to the patient’s transplant physician and the extent disclosure is required by law. LifeCell anonymizes and retains the information
on a secure computer that can only be accessed by specified personnel. The Client having understood the aforementioned points regarding the intention of
performing these tests hereby voluntarily consents and gives permission to perform the Inherited Diseases Testing and Pediatric Cancer Profiling Testing.
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |
EXHIBIT 6: AUTHORIZATION TO RELEASE PLACENTAL TISSUE ALLOGRAFTS FOR TRANSPLANT / RESEARCH / COMMERCIAL USE
(Applicable only to LifeCell Client Who Voluntarily Donate Their Child’s Placental Tissues)
Client also agrees that he / she has voluntarily elected to donate the Placental Tissues as a gift and will not be paid for this donation. The Client having understood
the risks and benefits, hereby gives consent to release the Placental Tissue Allografts of the Child for research, transplant or commercial use as solely
determined by LifeCell. Client may however revoke this authorization at any time by sending a written notification of desire to revoke to LifeCell. However such
revocation of consent will not be valid if LifeCell receives it after releasing the Allografts. Information related to the Child and Client shall remain confidential and is
only available for review by individuals designated by LifeCell or by quality and statutory authorities as necessary to evaluate the operations.
RISKS RELATED TO STEM CELL BANKING
Umbilical Cord Blood Stem Cell Banking has several inherent risks which may relate to collection, processing, testing , storage and usage of the stem cells. For
better transparency to the Client, the relevant risks in each of these areas are described below only to enable better decision making. However,
LifeCell commits that this shall in no way reduce its liability for any loss, harm , damage or claim of any kind in connection with this Agreement or
the Services provided by LifeCell or in no way diminish the benefits available as per Clause 8 under the LifeCell Client Benefit Programs. It has to be
noted that these risks are by no means comprehensive and are only indicative.
COLLECTION RISKS
Collection of Umbilical Cord Blood and Placental Tissues is usually done after clamping of the Umbilical Cord and separation of the Mother and Child and hence
poses no risks to either one. However, inherent risks of microbial contamination of the Umbilical Cord Blood present in the birth canal may render the Umbilical
Cord Blood unfit for storage. In rarely occurring circumstances or certain complications during delivery may entirely prevent the collection of Umbilical Cord Blood
or collection of adequate quantity of the Umbilical Cord Blood required for storage purposes. Client understands that engagement of trained personnel well in
advance and handing over the Collection Kit to them at the time of reaching the venue of childbirth are critical to increasing the chances of successful collection of
the Maternal Blood, Umbilical Cord Blood and Placental Tissues. Further, the Child's birth mother by law is required to be screened and tested for infectious
diseases using peripheral venous blood. The collection of the Maternal Blood may cause discomfort, possible bruising and swelling around the puncture site;
rarely an infection; and uncommonly, faintness from the procedure. Client assumes all risks involved in collection of Maternal Blood, and also understands that if
any of the results of infectious diseases testing on the Maternal Blood is positive, then LifeCell may decline to continue storing the Child's Umbilical Cord Blood
and/or Specimen and/or Placental Tissues.
TRANSPORTATION RISKS
Transport of the Umbilical Cord Blood and Maternal Blood from the place of childbirth to the LifeCell’s laboratory, or transport of the stored Specimen/s from
LifeCell laboratory to the patient's transplant center has to be done within a reasonable period of time for minimizing loss of viability. Utilization of certified
Collection and distribution kits designed to maintain a controlled environment for a reasonable period of time will help minimize these risks during such
transportation. Disruptions in flight or other transport operations, accidents, or theft, may cause the Umbilical Cord Blood and/or Specimen/s to be lost or delayed
in reaching the destination. The maintenance of Umbilical Cord Blood and/or the Specimen/s traceability at all times of transport and utilizing experienced courier
companies will help minimize these risks during transportation. Lastly, the Client understands that no surety can be provided by the third party courier company
or by LifeCell on the safe and timely transport and hence, the Client has the option of choosing at their own cost the best possible mode of transport of the
Umbilical Cord Blood and/or the Specimen/s.
TESTING RISKS
The Umbilical Cord Blood, Specimens and Placental Tissue Allografts are tested for reporting their identity and quality based on the results of which a decision is
taken on transplantation upon eventual need. LifeCell through extensive use of automated, bidirectionally interfaced, barcoded sample handling, and in-house
testing, that helps reduce the chances of errors; active participation in proficiency testing programs; and maintenance of accreditation from reputed institutions
provides Clients the assurance they seek on the reported results.
However, errors may happen in the pre-analytic, analytic, and post-analytical phases of testing due to systems, processes, and procedures involved in the
transmission and reporting of test results. Client understands that if in doubt, they have the opportunity of seeking external testing at their own costs to reconfirm
the results reported by LifeCell, for which LifeCell would offer its fullest cooperation.
STORAGE RISKS
Long-term cryo-preservation of the Specimens may be associated with risks of either loss of their viability, partial or total loss of the stored Specimens due to
reasons beyond the reasonable control of LifeCell. However, no assurance can be provided on the maintenance of viability for indefinite storage, and that the
Specimens may also be lost due to equipment failure and/or accident which may render the sample unfit for transplantation.
However, these risks may be minimized by placing the stored Specimens with barcodes in overwrap bags and metal canisters where applicable; maintenance of
Specimens in vapor phase of liquid nitrogen; and placement of high-risk/ quarantine Specimens in a separate dewar to avoid the chances of cross-contamination.
Also, maintenance of adequate nitrogen levels in the dewars through piped supply from bulk tanks for automated top-ups; provision of continuous monitoring and
automated alarm systems onto dewars, and supply with triple layer supply of electricity, power grid, uninterrupted power supply, and diesel generator; minimize
the chances of temperature deviations which may result in loss of viability. Adequate facility design considerations, running of regular stability testing programs,
maintenance of Specimens at multiple locations and procurement of insurance covers in accordance to the risks and procedures for safety and emergency
handling also help in providing added confidence to the Client.
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |
APPLICATION RISKS
Umbilical Cord Blood like bone marrow and peripheral blood, is rich in hematopoietic progenitor cells, and has been used in the treatment of a variety of inherited
or acquired disorders, including hematologic malignancies, metabolic disorders, and immunodeficiencies, etc. Also, several registered human clinical trials around
the world are currently exploring the potential of Umbilical Cord Blood Specimen to treat medical condition/s like Cerebral Palsy, Type 1 Diabetes, Autism
Spectrum Disorder, Traumatic Brain Injury, Stroke, Hearing Loss, etc. However, there is no guarantee of successful transformation of these human clinical trials
into commercial applications. The quantity of stem cells required for transplant varies depending upon the eventual use and/or patient's body weight. While
techniques for expansion of Umbilical Cord Blood Specimens have been promising, there is no guarantee that these will be eventually successful. Client is aware
that banking the Child’s Specimen does not guarantee that a stem cell transplant would be the first or best course of treatment for any particular medical
condition/s or that the Child’s own stem cell is useful for every medical condition/s treatable by stem cell transplantation. The patient’s transplant physician
ultimately decides whether the use of the Child’s Specimen is indicated, based on the nature and progression of the medical condition/s and in case of an
allogeneic stem cell transplantation, depending on the HLA matching between donor and recipient.
LIST OF TESTS PERFORMED
LifeCell commits to perform all the below mentioned tests at no additional cost to the Client for the Child, Child's biological sibling/s, Child's biological parent/s and
Child's biological grandparent/s from the Enrollment Date till the entire tenure of this Agreement.
Cord Blood:
At time of Storage
Cord Blood Group & Rh
Typing
Cord Blood Volume
Total Nucleated Cell Count
At 2 years from the date of birth
of the Child:
(Only for Specimens listed in
LifeCell Community Banking
Program Registry)
Hemoglobinopathies
Human Leukocyte Antigen
(HLA) Typing by NextGeneration Sequencing
Colony Forming Unit
(CFU) Assay
At retrieval for transplant:
Total Nucleated Cell Count
Total Mononuclear Cell
Count
Total CD 34 Cell Count
Total Mononuclear Cell
Count
Total CD 34 Cell Count
Hematocrit
Sterility
CD 34 Stem Cell Viability
CD 34 Stem Cell Viability
Hematocrit
Sterility
Colony Forming Unit
(CFU) Assay
HLA Typing by NextGeneration Sequencing
(NGS) for Donor
HLA Typing by NextGeneration Sequencing
(NGS) for Recipient
Inherited Diseases Testing
by Next-Generation
Sequencing (NGS)
Pediatric Cancer Profiling
Testing by NextGeneration Sequencing
(NGS)
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |
Maternal Blood:
Anti - HBC
CMV - IgG
Syphilis
Nucleic Acid test (HBV,
HCV and HIV)
CMV - IgM
HIV I/II
Blood grouping & Rh
typing
Anti - HCV
HBSAg
HTLV I/II
Malaria
No additional cost to the Client for confirmatory tests
Mesenchymal Stromal/Stem
Cells (MSCs)
At retrieval for transplant:
Viable Mononuclear Cell
Count
Sterility
Mycoplasma
Endotoxin
Cell Morphology
Differentiation Potential
Flow Marker Positives: CD
90, CD 73, CD 105
Flow Marker Negatives:
CD 34, CD 45, CD 14, CD
19, HLA-DR
Potency
LC/DOM/CB-CA/12-20/012.1
Mayur Abhaya, Managing Director,
LifeCell International Private Limited
LifeCell International Private Limited, #16, Vijayaraghava Road, 1st Lane, T. Nagar, Chennai - 600017, Tamil Nadu, India. | 1800 266 5533 | www.lifecell.in |