Family Bank: Biocell

About

Biocell® is the stem cell bank unit of Regrow Biosciences Pvt. Ltd. Biocell® is India's leading umbilical cord blood bank committed to preserving life-saving stem cells for your family's health needs. To make an appropriate decision, Biocell® gives customers 100 reasons to choose them as their stem cell banking partner.

Biocell offers “Hybrid Cryopreservation Program” which is better and patient centric as compared to ‘community banking service’ offered by some companies. In this program, a client retains ownership of his own private sample (for Autologous use) throughout the agreement tenure, while at the same time as a member of the broader ‘Biocell Community’, he can access the pool of matching samples from ‘Biocell Community’ (for Allogeneic use) through an informed consent process, as the situation may demand.

Labs and Locations

The Biocell® stem cell facility is located 83 kms from Mumbai and 90 kms from Pune, situated in Maharashtra, India. The facility is well-equipped to undertake cryopreservation of stem cells for several decades. The stem cell facility is constructed to resist floods, fire, smoke, and power outages, and is located in a non-seismic zone

Business Experience

Biocell® started operations in 2009 with establishment of their Good Manufacturing Practices (GMP) certified laboratory. Biocell® has secured the trust of over 50,000 parents. The stem cell facility has branch offices and franchise partners in multiple Indian cities. Biocell® has developed and commercialized three target cell lines since 2009, while many are in the pipeline for commercialization, integrated with
the cord blood banking facility.

Collection Kit

The Biocell® 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. Biocell relies on gravity collection of cord blood into the collection bag. The bag is pre-filled with the anticoagulant CPD and has a safety lock to avoid needle pricks and damages during collection. Special disinfection supplies enclosed with the kit include Sterile drape, Sterile surgical gloves, Sterile gauze swab, 70%Alcohol swabs, and 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. The Biocell® Collection Kit  ensures that the baby’s stem cells are protected against fluctuations in external temperature and other damages. For that purpose, we perform validation tests of the collection kit for different times and different environmental conditions to verify there are no temperature fluctuations.

• Outer kit Bag (i.e. plastic monsoon cover) - for protection of sample during monsoon season. This prevents seepage of water and keeps your samples dry, hygienic and safe from contamination.
• Thermocol Box covered with cardboard box contains cold gel packs -This keeps cord blood sample at optimum temperature for transport up to 72 hours, by which time your samples are safely delivered to our processing facility.
• The kits are completely sealed to avoid any contamination.
• Data Logger - for monitoring transportation temperatures a data logger is provided with collection kit which assures that your kit is maintained within a defined temperature range. At the time of kit receipt at the facility temperature is checked again before further processing.
• Biocell® Collection Kit also provides these associated documents
• Umbilical Cord Blood Collection procedure
• No X-ray Certificate

Shipping Info

Biocell® makes shipping arrangements on behalf of the parents anywhere in India at no extra cost. A Biocell® employee picks up the Collection Kit from the birthing center and takes it to a courier company (TNT, Sequel, DHL, Marken Biological Logistics) which ensures that it is transported to our processing facility on 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 (72 hours). The Biocell® lab is open 24x7x365 days including holidays. Shipping is included in the base price within the home country. Additional costs apply when shipped from outside India.

Processing Method

Biocell® uses a closed bag system, double sedimentation and spin technology to yield the maximum number of stem cell from cord blood. Thanks to the closed bag system, sample sterility is maintained throughout the process so there are no chances of post-processing contamination. The entire processing activity is performed in a GMP certified lab area in class 100 Biosafety cabinets. We remove red blood cells (RBC) because they can have toxic side effects during transplantation. After removing plasma and RBCs, stem cells are concentrated from the remaining blood. Isolated stem cells are mixed with cryoprotectant which protect the cells during cryopreservation. Then the sample are cryopreserved with control rate freezing which cools the sample slowly to avoid any cell damage during freezing.

Components Stored

Biocell® provides its clients with a detailed cryopreservation certificate describing test results which include: Cord Blood Group and Rh typing, Hematocrit, Total Nucleated Cell (TNC) Count, Total Nucleated Cell (TNC) viability,Total Mononuclear Cell (MNC) Count, Total CD34+ Cell Count, CD34+ Stem Cell Viability, Sterility, HPC Profiling which include detailed information of progenitor stem cells count and its viability. 

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. We also perform tests for Hemoglobinopathies, confirm stem cell viability with the CFU assay, and HLA Type the sample at the time of storage.

Additional tests (at no extra cost) on stored cord blood at the time of transplantation include: Total Nucleated Cell (TNC) Count, Total Nucleated Cell (TNC) viability, Total Mononuclear Cell (MNC) Count, Total CD34+ Cell Count, CD34+ Stem Cell Viability, Hematocrit, Sterility, CFU assay and HLA typing for donor and recipient which is performed on contiguous segments to cord blood final storage bag. Additional maternal blood sample, reference, and retention sample (identical of stored cord blood sample) are also preserved for future testing purposes (if any).

Storage Method

The final cord blood stem cells are stored in a cryobag which is encased in overwrap. This bag is then placed in a metal cassette to avoid any physical damage during preservation. After control rate freezing, the sample is kept temporarily in a quarantine cryovessel, and after it clears infectious disease testing and sterility testing it is moved to long-term storage in the final storage cryovesssel. The cord blood samples in the final cryovessel tank are stored in the vapor phase of cryogenic nitrogen which maintains temperature below -150 degrees Centigrade. Daily temperature monitoring of the cryovessel is also carried out by engineering team to ensure the correct temperature conditions.

Licensing & Accreditation

Biocell® is licensed and certified by the following organisations.

• Licensed by the Indian Ministry of Health (Indian FDA)
• Licensed for cord blood banking by Drug Controller General of India (DCGI).
• R&D in-house facility is licensed by DSIR, part of Ministry of Science & Technology, Government of India.
• For transplant purposes Biocell® has its IC-SCR (Ethics Committee) registered with NAC-SCRT (ICMR).
• IEC by Central Drugs Standard Control Organisation (CDSCO)
• Good Manufacturing Practices (GMP) certified by FDA, CDSCO and British Standard Institution (BSI/ SGS).
• Good Laboratory Practices (GLP) quality control testing from BSI/ SGS.
• Good Clinical Practices (GCP) from BSI/ SGS.
• WHO GMP license by SGS
• BSI is recognized by World Health Organization (WHO) and hence samples are acceptable worldwide.

Clinical Experience

Biocell® provided a cord blood transplant for a child with the metabolic disorder MPS VI in the year 2015. Another cord blood transplant was performed for Beta Thalassemia Major in 2016. In total, Biocell® has released three cord blood units for transplant and facilitated a total of 2000 cell therapies.

Biocell® has partnership networks with all the major Hospitals/ Doctors including AIIMS, Apollo, Fortis and many more. Biocell® also works with clinics offering regenerative medical therapies. Biocell® develops medical products from cord blood donations where cells derived from the cord blood are enriched and expanded with proprietary cell culture media for future therapeutic application in malignant and nonmalignant blood disorders.

Insurance

Biocell® will provide clients with a matching cord blood unit from the hybrid community inventory if needed, while at the same time the client retains the ownership of his own sample. Biocell® has kept a provision of philanthropic monetary support to the client to cover the expenses in case of such treatment requirements.

Under the “Biocell Philanthropy Program”, if the Child or any member of family is diagnosed with disease or condition treatable by hematopoietic cord blood stem cell transplantation using the child's own Umbilical Cord Blood Unit cryopreserved with Biocell, then Biocell provides monetary support as per actual expenses or INR 20,00,000 towards such treatment to offset actual transplantation cost.

Community Service

If the child or its sibling or either of its genetic parents requires cord blood stem cell transplantation, Biocell® will make special arrangements through their hybrid banking system. Biocell® offers special pricing for members of defenses personnel and medical fraternity.

Prices

Biocell® prices are inclusive of all costs like Enrollment, Logistics, Processing, Storage, Retrieval, Value Added Services. No hidden costs. Storage interval is a choice between Long term (21 years) or Life time (75 years). Payment plans available upon request - visit https://biocell.in/ or phone Toll Free 1-800-209-0309.

Additional Services

Biocell® clients can obtain cell therapy through the parent company Regrow® and the packages can be explained through a teleconference, video conference or a personal meeting with our sales and medical counselling teams. Regrow Biosciences Pvt. Ltd. develops cell therapy products and is the only company which has received approval for commercialization from the Indian FDA (DCGI) for its three cell-based products Cartigrow®, Ossgrow® and Uregrow®. Many more novel products are in the pipeline to fully leverage the benefits of cell-based therapy for multiple diseases and conditions.