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Family Bank: LifeCell
Established in 2004, LifeCell International Private Limited is India’s leading provider of preventive healthcare services for family wellness, such as umbilical cord stem cell banking and diagnostic testing. LifeCell was founded in technological collaboration with Cryo-Cell International Inc., based in Florida, USA - the world’s first private stem cell bank with over 25 years of experience. LifeCell has two state-of-the-art laboratories at Chennai & Gurgaon and a network spanning over 200 service centers in India and footprints in GCC countries.
‘BabyCord’, LifeCell’s umbilical cord stem cell preservation service, is one of the world’s largest cord blood banks, with over 2,00,000 clients already trusting their baby's stem cells to LifeCell, and over 50,000 new clients joining each year.
The recent launch of BabyCord Share, a community-based approach towards stem cell access, is a global first and aims to provide families in India better future access to stem cells than even currently possible in advanced countries.
LifeCell’s testing, processing and storage facilities are the most accredited having received recognitions from domestic and global bodies such as the AABB (formerly American Association of Blood Banks), College of American Pathologists, National Accreditation Board for Laboratories, World Health Organization, amongst many others, and is also US FDA registered. BabyShield - LifeCell’s preventive genetic screening and diagnostic testing services, is India’s market leader for newborn screening services and recently forayed into prenatal screening. Know more >>
Why Community Banking?
According to statistics, the estimated individual risk of acquiring a blood or immune condition that may need treatment by stem cells transplant is 1 in 20. In 80% of these conditions, patients require treatment with stem cells from a suitable matching donor since they cannot use their own stem cells. Despite this large need, very few patients in India receive transplants, due to lack of matching stem cells for treatment and prohibitive costs in sourcing a stem cell unit. India has a listing of 1,80,000 bone marrow stem cell donors, which is far less than 1% of the global stem cells donor base, despite accounting for 20% of world population. Moreover nearly 40-50% of these bone marrow stem cell donors are either unavailable or refuse to donate at the time of request.
Secondly, the inventory held by public cord blood banks in India is only about 5000 units, which is less than 1% of global inventory. Moreover, the cost of sourcing matching stem cells from public banks from elsewhere in the world could cost around INR 15 to 20 lakhs making it unaffordable to many. As per a 2014 study funded by the Indian Council of Medical Research (ICMR), if 2.5 lakh cord blood units of Indian origin are made available, chances of patients in India finding a matching stem cell unit will exceed that of even a patient in advanced countries such as U.S.
Families have resorted to protecting their future stem cell needs by preserving their baby’s umbilical cord stem cells at family (private) banks. However, this may not be a complete solution since only 20% of the conditions that are treatable by stem cells can use the baby’s own stem cells.
The ideal solution to this challenge is to have a new approach to umbilical cord blood banking that can be beneficial to the child, its family and also to a larger community.
What is BabyCord Share - Community Banking?
LifeCell’s BabyCord Share - Community Stem Cell Banking provides sharing of preserved umbilical cord blood stem cells amongst this exclusive community of parents, who have preserved their baby's stem cells at birth with us. This allows the members to access a pool of unrelated stem cell donors in the event they need donor stem cells for transplants, instead of seeking donor stem cells from public cord blood banks or bone marrow registries. In addition to the child, other siblings of the child and parents too can access this community pool, thus providing a comprehensive family benefit for treatments using stem cells.
How does BabyCord Share Community Banking help?
- Higher Matching Probability: With over 50,000 units of Indian origin being added every year (notwithstanding the existing inventory of 200,000 units with LifeCell which may get added to the community if parents opt in), the chances of finding a matching Indian unit for transplant in the community would soon exceed that of any place worldwide.
- Low cost & no restrictions: No additional cost to procure these stem cells when required for transplant, and no restriction on the number of units that can be withdrawn from the pool.
- Immediate Availability For Transplant: Frozen umbilical cord blood stem cells can be accessed immediately for transplant without any further dependency on donor availability or consent.
In addition to providing better access & availability of stem cells for the child and the family, LifeCell also offers a host of benefits for customers who register with them for Community Banking. Know more>>
To become the world's largest stem cell solutions provider, with the largest repository of lifesaving stem cell assets, and thereby contributing significantly to the ever-developing scope of transplant medicine. To minimize the high disease burden in India and ensure that every baby born in this country is healthy by providing high quality diagnostic and preventive care services.
Labs and Locations
Laboratory #1 (Processing facility and primary storage facility)
#26, Vandalur Kelambakkam Main Road, Keelakottaiyur, Chennai - 600127, Tamil Nadu, India.
Laboratory #2 (secondary back-up storage facility)
Plot #26, Sector 4, IMT Manesar, Gurgaon 122001, Haryana, India.
Video tour of our advanced laboratories:
Since its inception in 2004, LifeCell has successfully collected, tested, processed and cryo-preserved samples of over 2,00,000 (2 lakh) babies.
The LifeCell Collection Kit uses the Terumo Penpol 150 ml blood bag that is sterile and can be used in the operating room during a C-section or normal delivery. The bag is pre-filled with the anti-coagulant CPD and has a safety lock to avoid needle pricks and damages during collection. Disinfection supplies included: 2 Alcohol Prep Pads, 1 set Sterile Gloves, 1 Sterile Sheet and 1 Iodine Swab. Know more >>
The LifeCell Shipping container has foam bricks which maintain temperature for longer periods compared to gel packs. The container is certified by the Indian Institute of Packaging and guaranteed to maintain optimum temperature for 72 hours. We always record the temperature at the time point of receipt at our laboratory and proceed accordingly. Know more >>
LifeCell has a partnership with a critical logistics provider which is certified by International Air Transport Association (IATA). A courier picks the sample from the birthing center and ensures that it is transported to our processing facility in the next available flight, even during weekends and holidays. This ensures that the transit time is minimized and the samples reach our laboratory within the recommended time frame. Shipping is included in the base price within the home country. Additional costs apply when shipped from outside India. Know more >>
LifeCell uses its proprietary red-cell depletion and plasma reduction technique that is customized to the volume of collection obtained, by employing differential centrifugation technology in a sterile triple closed bag system. In this technique, hydroxyethyl starch (Hetastarch or HES or HESPAN®) is used for the density gradient centrifugation process. Our process ensures median cord blood stem cell recoveries (TNCC recoveries) greater than 80% which is comparable to those of automated techniques. Importantly, our advanced technology allows significantly higher red blood cells (RBCs) depletion resulting in much lower hematocrit concentration (left over RBCs) in the final product. Our median hematocrit concentration of final product is around 5% compared to over 15-25% being reported for automated techniques. The RBC depletion post processing is in excess of 95% which makes our technology the most preferred from a transplant perspective as it avoids the needs to perform a washing step that may lead to loss of precious stem cells. Only 0.1% of our samples have haematocrit values greater than 40%. The entire processing is performed in a completely closed system, along with bar coded interface thereby eliminating scope of error. How Personalised Cord Blood Processing Works?
LifeCell's facility was the first stem cell bank in India and second in the world to be audited and certified for all activities involving donor's qualification, collection, testing, processing and storage by AABB for Cellular Therapy (Somatic Cell activities) which covers our activities for cord tissue. To provide a high degree of assurance on isolation of mesenchymal stem cells (MSCs) from the umbilical cord tissue, LifeCell uses its proprietary explant tissue culture technology whereby at least 1-2 million cells are obtained and assessed using the Cell Proliferation Assay prior to storage for their identity, viability, and sterility. This process also ensures that the time to provide cells for transplant is substantially shorter. Also, at no additional cost, a portion of the native umbilical cord tissue is also preserved so that any future cell line isolation or an improved culture technique that may be available in the future is possible to deploy. How Personalised Cord Tissue Processing Works?
LifeCell provides its customers with a detailed preservation certificate describing test results which includes the Cord Blood Volume Collected, Cord Blood Group and Rh typing, Hematocrit, Total Nucleated Cell (TNC) Count, Total Mononuclear Cell (MNC) Count, Total CD34+ Cell Count, CD34+ Stem Cell Viability and Sterility. Maternal blood is screened for Blood Group and Rh Typing, Anti-HCV, Anti-HBC, HBSAg, HTLV I/II, Malaria, CMV-IgM, CMV-IgG, HIV I/II, Syphilis; and Nucleic Acid Testing (NAT) is performed for HIV and HCV viruses in accordance with requirement of national and international regulatory authorities. We also perform hemoglobinopathies at the time of storage.
Additional tests (at no extra cost) on stored cord blood at time of transplantation include Hemoglobinopathies, Total Nucleated Cell (TNC) Count, Total Mononuclear Cell (MNC) Count, Total CD34+ Cell Count, CD34+ Stem Cell Viability, CFU assay and HLA typing for donor and recipient which is performed on the integrally attached segments to cord blood final storage bag. Additional maternal blood sample is also preserved for future testing purposes (if any).
As per the current ISCT guidelines, we check the mesenchymal stem cells harvested from the cord tissue for its proliferation capacity, adherence to plastic in standard culture conditions; perform marker analysis during retrieval for positive markers (CD90, CD105 and CD73) and negative markers CD34, CD45, CD19 along with HLA-DR. Know More>>
Final storage of processed cord blood is in a FDA recommended multi-compartment cryo-bag encased in an overwrap. The bag is kept temporarily in a quarantine freezer, and after it clears infectious disease testing it is moved to a long-term storage cryo-chamber or dewar. The cryo-chambers are kept cold (below -1500 centigrade) in vapor phase of cryogenic (liquid) nitrogen. Know more>>
Licensing & Accreditation
Currently, LifeCell laboratory holds many registrations, licenses, and accreditation standards as follows:
- DCGI (Drug Control General of India) licensed
- DSIR (Department of Scientific and Industrial Research) licensed for R&D
- AABB (formerly American Association of Blood Banks) for Cord Blood
- AABB (formerly American Association of Blood Banks) for Somatic Cell Therapies
- CAP Accredited (College of American Pathologists)
- US FDA Registered (United States Food and Drug Administration)
- WHO GMP for Blood Establishment
- NABL (National Accreditation Board for Testing and Calibration Laboratories)
- ICCBBA Registered (International Council for Commonality in Blood Banking Automation)
- ISO 9001:2008 (International Standards Organisation) certified by DNV
- ISMS (Information Security Management System) accreditation
LifeCell has successfully retrieved 45 cryopreserved cord blood units of which 7 were for autologous transplants (child using own cord blood stem cells) and 38 for allogenic transplants (patient using child's cord blood stem cells upon suitable HLA match) (data as on February 2017).
Client Benefit under Community Banking Program
- INR 2,000,000 Financial Assistance for the child and siblings during the first 21 years to offset stem cell transplant expenses. On the request of the Client, LifeCell can also make this payment directly to the transplant center.
- Full Refund of banking fees (except sample collection charges) if the child's sample is released to another community member, while the customer continues to enjoy the benefits of LifeCell Community Banking Program and LifeCell Client Benefit Programs as applicable until seventy five years from the date of birth of the child.
- Free Worldwide Shipment of stem cells to any part of the globe for a transplant.
- Free Stem Cell Expansion of both mesenchymal stem cells and hematopoietic stem cells should that be medically necessary as determined by the patient’s transplant physician.
- INR 2,000,000 Quality Guarantee if, in the opinion of the patient's transplant physician, the preserved stem cells are not viable for transplant due to any reason.
- INR 2,000,000 Disaster Relief if the stem cells are lost or damaged during transit, processing and storage. The preserved stem cell assets at LifeCell are already insured for a value over INR 5 billion. This provides a cover to purchase a replacement unit from any public stem cell bank worldwide in the event of unit loss beyond the reasonable control of LifeCell (covering both the cord blood and cord tissue). This cover also includes transit insurance from the birthing center to our laboratory and also at the time of retrieval, from our laboratory to the patient's transplant center. In such event, LifeCell would try to find a matching sample within 14 days from any public bank in the world, failing which LifeCell would pay INR 20 lakh to the Client.
- Paramedic support for collection and express shipment to courier the sample to our lab.
- Medical Concierge at no additional cost to provide all transplant related information.
- Testing of Samples at time of retrieval at no additional cost.
- Our Entitlement to Full Refund ensures that in the event the sample is not collected due to the health and life related priority of the baby or mother or unfortunately non-survival of the baby at birth, LifeCell refunds all fees paid by Client.
- Our Storage Fee Waiver program ensures that in case of unfortunate demise or permanent physical disability of parent, LifeCell would continue storage of the stored Specimen at its own cost till the Child attains the age of majority.
- Annual Preservation Status Report: In an industry exclusive service provided by LifeCell, on every birth anniversary of the Child, LifeCell shall send an Annual Preservation Status Report to its customers, which shall contain monthly temperature data of the cryo-chambers in which the stem cells are being stored which is recorded automatically from our highly advanced temperature monitoring software, thereby assuring the parents that the stem cells are safely stored in accordance to approved Standard Operating Procedures and in compliance with statutory regulations.
The Community Stem Cell Banking service will be available to customers with at a starting price of INR 16,990/- with an Annual Storage Fee of INR 4,000 per annum. LifeCell also offers additional long-term plans wherein customers can choose to prepay the storage fee. Know more about our Pricing Plans >>
LifeCell offers several additional preventive health care services as: