LifeCell Arabia - Bahrain

About

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 >> 

Guarantees

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.