Family Bank: LifeCell

About

Established in 2004, LifeCell International Private Limited is India’s leading biotech company providing preventive healthcare services for family wellness, such as umbilical cord stem cell banking, diagnostic testing and prenatal tissue derived therapeutic products. Our vision is to become the world’s largest stem cell solutions provider with the largest repository of life saving stem cell assets and thereby contributing significantly to the ever-developing scope of transplant medicine. We aim to minimize the high disease burden in India and ensuring that every baby born in this country is healthy by providing high quality diagnostic and preventive care services. 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 27 years of experience. LifeCell has two state-of-the-art laboratories at Chennai & Gurugram and a network spanning over 200 service centers in India and footprints in GCC countries. LifeCell is India’s largest and world’s third largest umbilical cord stem cell bank, with over 3,50,000 cord blood samples already preserved. LifeCell’s Community Cord Blood Banking approach towards stem cell access, is a global first and aims to provide families in India better 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, WHO cGMP, ISO, amongst many others, and is also US FDA registered. LifeCell’s Diagnostics division offers services like Prenatal Screening Tests, RightStart Tests (NewBorn Screening), Genetic Testing, Genetic Counselling, etc. Know more >>

Current Need In India For Stem Cells Transplants and Reasons For Low Stem Cells Transplantation:

According to statistics, 1 in 217 people will have a stem cell transplant (not just need one, but have one) by age 70. In 90% of these blood related conditions, patients require treatment with stem cells from a suitable matching donor since their own stem cells contain the same genetic defect (root cause) that causes the disease, and hence cannot be used for transplantation. As per World Health Organization’s International Agency for Research on Cancer, India has third highest number of blood cancer patients in the world after the US and China. However, from the first ever transplant in 1983 to 2015, India has reported a dismal 10,381 blood stem cell transplantations; 6,240 were allogenic (donor stem cells) and 4,141 were autologous (own stem cells) transplants. India’s current capacity is suboptimal to meet the needs for India's population with an estimated incidence of 10,00,000 new cancer patients per year. 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.

Challenges Faced by Public Cord Blood Stem Cell Banks in India:

1. Low Inventory: The total inventory of purely public cord blood units in India is below 6500 CBUs. Jeevan, the only public bank that lists Indian cord blood units for transplant, has stopped to accept further cord blood donations due to lack of funds. Globally, there are about 750,000 public CBUs spread over 55 major public banks in the world.  But the ability to find a donor that is a close enough match for transplant depends on ethnicity, and calculations show that the chance of an Indian finding a match from these global cord blood banks is less than 10%. India has a listing of 4,50,000 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, 40-50% of these bone marrow stem cell donors are either unavailable or refuse to donate at the time of request.
2. High Cost: Currently, the cost to procure a single public cord blood unit in India is INR 15-20 lakhs. The cost to procure a public CBU from abroad varies by bank but is typically INR 30 lakhs. An adult patient may require two CBUs for a transplant, doubling the cost. Additional expenses, such as hospital costs, might accrue to INR 15-20 lakhs.
3. Need to Grow: As per a 2014 study by the Indian Council of Medical Research (ICMR), for an Indian patient to have a 96% chance of finding a well matched cord blood transplant, the public inventory should be at least 25,000 CBU.

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.

How LifeCell’s Community Bank Overcomes the Challenges of Public Banks:

LifeCell’s Community Stem Cell Bank works similar to a public bank: Parents contribute their baby’s cord blood stem cells to a common pool for use by themselves and other members of this community. This increases the chances of finding a suitable matching donor and thereby expands the treatment options for patients. Thus the Community Banking model completely aligns with recommendation by the Indian Academy of Pediatrics (IAP) and the Indian Medical Association (IMA). Not only does Community Banking solve the challenges of low inventory and high costs of the public banking model, it is also a more sustainable business model compared to public banks.

1. Sufficient Inventory: By 2023 Q1, LifeCell’s Community Bank has over 75,000 qualified cord blood units. This is over ten times the inventory of India’s public banks and meets the required size to provide minimum matches for 96% of Indian patients.
2. Complete Family Protection: LifeCell’s Community Bank is designed to provide access to cord blood transplant to the baby, the baby’s siblings, as well as the baby’s parents and baby’s grandparents (maternal and paternal). Even if the baby’s cord blood unit is used by another member of the community, the baby’s family continues to enjoy the benefits of community banking during the baby’s entire lifetime.
3. Unlimited Retrieval Free of Cost: In the event of a medical need, participants in the LifeCell Community Bank do not have to pay to procure a cord blood unit from a member of the bank. Payment was made at the time of joining when their baby’s stem cells were contributed to the bank. Services provided for free include state-of-the-art next generation sequencing of the HLA type (Human Leukocyte Antigens) needed for transplant matching. This service is provided for the baby, siblings, parents and grandparents.
4. Financial Assistance: Participants in the LifeCell Community Bank receive INR 20 lakhs towards treatment expenses for each transplant of the baby, siblings, and parents. If a matching cord blood unit cannot be found for a participant, the payment of INR 20 lakh can be applied towards procurement of a transplant with bone marrow or peripheral blood stem cells.
5. Goodwill Gesture: Parents will receive a full refund of monies paid (except sample collection charges) if their baby’s cord blood unit is used by another member of the community. In such an event, the baby and entire family continues to enjoy the benefits of Community Banking till the child turns 75 years of age.
6. Exclusive Community Registry: Only participants in the LifeCell Community Bank can retrieve cord blood units from the bank.
7. 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.
8. Protection Against Rejection: Even if baby’s cord blood unit is found to be too small or unfit for storage/processing, Clients are still covered for all the benefits unlike other private banking models.

Labs and Locations

Laboratory #1 (Processing facility and primary storage facility)
No. 26, Vandalur Kelambakkam Main Road, Keelakottaiyur, Chennai - 600127, Tamil Nadu, India. 

Laboratory #2 (secondary back-up storage facility)
Plot #26, Sector 4, IMT Manesar, Gurugram 122001, Haryana, India.

Video tour of our advanced laboratories:

Business Experience

Since its inception in 2004, LifeCell International has successfully collected, tested, processed and cryo-preserved cord blood samples of over 3,50,000 (3.5 lakh) babies.

Collection Kit

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 anticoagulant 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.

Transportation container

Optimal standards of cold chain and physical safety are necessary for the maintenance of cell integrity and quality of the sample that is transported. LifeCell’s stainless steel kit ensures that the baby’s stem cells are protected against fluctuations in external temperature and other damages.

• Super Strong Stainless Steel Box: The new kit is made of tough stainless steel with a tensile strength that is more than 700 times the tensile strength of thermocol.
• Vacuum Insulated Temperature Maintenance: This keeps your sample in the optimum temperature for transport up to 72 hours by which time your samples are safely in our labs.
• Eco-Friendly: Our steel kits are durable and are meant to last for a long time They are recyclable and reduces our carbon footprint.
• Contamination Proof: The kits are completely sealed. This prevents seepage of water and keeps your samples dry, hygienic and safe from contamination.
• Compact: The advanced steel kits are almost 40% more compact than the old packs. Specific slots designed into the body of the kit ensure the contents avoid shakes and jerks!

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 >>

Shipping Info

LifeCell has a partnership with a critical logistics provider which is certified by International Air Transport Association (IATA). A courier company 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 >>

Processing Method

What: We'll process umbilical cord blood samples using our proprietary "Pentastarch Cord Blood Processing System."

Why: Our team of experts have developed a personalized, cGMP-compliant, double centrifugation-based Pentastarch cord blood processing system. It uses a manual sample-specific approach, ensuring a higher number of nucleated cell recoveries, high-quality blood-forming stem cell product, while substantially reducing red blood cell levels, all at significantly lower costs. The process involves red blood cell reduction with pentastarch, which is similar to hetastarch. This is followed by plasma depletion and cryopreservation in special dual-chambered cryo-bags with compartmentalized volumes of 5 mL and 20 mL, along with attached segments for future testing needs.

Competitive Edge:

• Our technology concentrates stem cells by minimizing plasma and red blood cells, optimizing storage space utilization.
• Other methods like the automated Sepax and AXP devices are available for cord blood processing. However, their biggest limitation is the presence of high levels of Red Blood Cells (RBC) in the final product, which can be detrimental. When the stem cell sample is thawed for infusions, the red blood cells will burst and release free Hemoglobin, which is dangerous for patients and must be removed with a washing process. During this washing, stem cells are lost, lowering the potency of the final infusion that the patient receives.

Components Stored

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 and HLA Typing by NGS technology on the cord blood units which qualify to become a part of the LifeCell Registry at the time of storage. Additional tests (at no extra cost) on stored cord blood at time of transplantation include Total Nucleated Cell (TNC) Count, Total Mononuclear Cell (MNC) Count, Total CD34+ Cell Count, CD34+ Stem Cell Viability, Hematocrit, Sterility, CFU assay and HLA typing for donor and recipient by NGS technology 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 would test the mesenchymal stem cells (MSCs) 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>>

Storage Method

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 -150 degrees 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)
• AATB (American Association of Tissue Banks)
• 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.

View Certificates

Clinical Experience

LifeCell has successfully facilitated 61 cord blood stem cell treatments, including both transplants and infusions. The patients include 13 cases using the child's own  stem cells and 48 using sibling’s matched stem cells. This includes 14 international shipments (11 in the USA, 2 in Singapore and 1 in Thailand). [Data as on February 2020]. Know more: download the full description of the cases >> 

Insurance

Client Benefit under Community Banking Program

• Financial Assistance of INR 20 lakhs for the Child, Siblings and Parents during the first 21 years to offset stem cell transplant expenses for every transplant. On the request of the Client, LifeCell can also make this payment directly to the transplant center.
• Coverage for Bone Marrow or Peripheral Blood Stem Cells Transplant of INR 20 lakhs for every transplantation for baby, siblings & parents.
• Complete Protection to the baby’s siblings, parents and grandparents (maternal & paternal) by providing unrelated donor stem cells.
• Unlimited samples retrievals and absolutely free of cost each time for entire family.
• Best probability of finding matching donor stem cells in the LifeCell Registry of more than 25,000 qualified cord blood samples, there is 96% chances of finding a match for an Indian patient.
• Exclusive Access to LifeCell Registry which is already 4 times larger than any public stem cell bank in India.
• Dual Storage: India’s only stem cell bank offering simultaneous storage at Chennai and Gurugram facilities for disaster management, back-up and added retention security.
• Free of cost “GENOME-SCOPE” tests for every stem cell transplantation.
• Disaster Relief of INR 20 lakhs each for every stem cell transplantation in case of any loss, harm, damage of the collected cord blood sample at the birthing center and/or processed stem cells; during transit, processing and/or storage for any unforeseen reason that is beyond the reasonable control of LifeCell including natural calamities until seventy five years from the date of birth of the Child.
• Quality Guarantee of INR 20 lakhs each for every stem cell transplantation in case of quality failure until seventy five years from the date of birth of the Child.
• Protection Against Rejection: Continued protection of stem cells for the baby and entire family even if the baby’s cord blood is of low volume / unfit for processing / storage.
• Full Refund: If the child's stem cells are released to another LifeCell community member, 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 and also provide continuity of benefits available under the LifeCell Community Banking Program and LifeCell Client Benefit Programs until seventy five years from the date of birth of the Child.
• Free Worldwide Shipment: LifeCell at no additional cost to the Client shall make the stem cells available for delivery within 7 days in India or any part of the globe for transplant.
• Free Stem Cell Expansion of both hematopoietic stem cells and mesenchymal stem cells should that be medically necessary as determined by the patient’s transplant physician.
• 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.
• 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.
• Storage Fee Waiver program ensures that in case of unfortunate demise or permanent physical disability of parent, LifeCell would continue storage of the stored stem cells 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.
• Safe Transplantation Program: LifeCell is the 1st and currently the only stem cell bank globally to perform genomic profiling of stem cell units before transplant at no extra cost. Want to know the benefit of this exclusive genetic test on every cord blood unit before release? Know More >>

Prices

• LifeCell Community Stem Cell Banking service will be available to Clients with at a starting price of INR 19,990/- with an Annual Storage Fee of INR 4,000 per annum.
• Please note that the sample collection charges are payable extra as applicable basis the delivering hospital.
• We also offer many interest free and pocket friendly EMI schemes.
• LifeCell also offers additional long-term plans (21 years and 75 years) wherein Clients can choose to prepay the storage fee.

Know more about our Pricing Plans >>

Additional Services

LifeCell offers several additional preventive health care services as:

1. Prenatal Screening
2. Genetic Testing
3. Genetic Counselling
4. Newborn Screening
5. Biologics - Perinatal Tissue Derived Therapeutic Products
6. Genome-Scope

About Genome-Scope:

LifeCell has introduced this test under the brand 'Genome-Scope'. This breakthrough test uses advanced next-gen DNA sequencing technology to assess over 4000 genes related to early childhood-onset disorders, to provide results with >95% accuracy within just 10 days. Thus, it has the potential to not only expedite the diagnostic journey but also, to save lives. While not all conditions detected may have treatment, the parents may seek such information as it may help prepare for the care of the baby and also in future family planning.

Genome-Scope is also available for healthy kids to identify predisposition to genetic conditions that, if detected late, could cause irreparable harm. It also provides information on how & which medications the child would respond to, thus providing access to the practice of personalised medicine. Genome-Scope will serve as a particularly important tool for those parents with a family history of a genetic disease, or those who have previously lost a child to one. However there is also data suggesting that 80% of babies with genetic diseases are born to parents with no family history or symptoms, implying the importance of this test to all families.

The Genome-Scope test is conducted through a simple process on the cord blood obtained from the baby right after birth for the extraction & preservation of umbilical cord blood stem cells. Alternatively the test could also be done with blood samples obtained from the child after birth through heel prick. The test results are shared with the physician within 10 business days for their reference. Lifecell's in-house certified genetic counsellors would assist the clients in pre and post test counselling. The raw data is also stored with LifeCell for future re-analysis in case there are any changes in the clinical status of the baby.