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Family Bank: Biocell

About

Biocell® (formerly known as Babycell), 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. Umbilical cord blood and cord tissue contains pristine and powerful stem cells capable of curing dozens of life-threatening diseases. Our stem cell facility ensures that this invaluable resource is available for future medical treatments. Choosing a cord blood bank is one of the most important decisions to make for your family’s wellbeing. To make an appropriate decision, Biocell® gives customers 100 reasons to choose them as their stem cell banking partner.

Labs and Locations

Biocell® stem cell facility is located at Address- 22, Shah Industrial Estate, Lonavala- 410401. The labortory is 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 has geographical advantages like:

  • Flood proof
  • Pollution proof
  • Fire proof
  • Power-outage proof
  • Located in a non-seismic zone

Business Experience

Biocell® started operations in 2009 with establishment of Good Manufacturing Practices (GMP) certified laboratory at their own Cell Preservation Centre™.  Biocell® has secured the trust of over 50,000 parents. Biocell® adheres to GMP and follows Good Laboratory Practices (GLP) for its laboratory operations ensuring quality at utmost priority. The stem cell facility has branch offices and franchise partners in more than 25 cities in India with collection capabilities in more than 600 cities. The facility provides collection services round the clock with a successful sample collection track record of more than 95% over the last 10 years.

Collection Kit

Biocell® cord blood collection kit is specially designed to meet the Indian FDA and biological sample requirements. The kits are temperature validated with temperature ranging from 18-25°C for up to 72 hours as per the FDA guidelines. The collection kit is sterilized from outside and inside and is appropriate to use for C-section births.

Kit contents:

  • Conditioned gel packs to maintain the temperature of 18-25°C during transit
  • Thermocol lid to avoid the direct contact with the gel packs to avoid hemolysis of the cord blood
  • A human umbilical cord blood collection bag (approved Collection Bag) with haemostatic clamps containing anti-coagulant (CPD)
  • SOP for cord blood collection components
  • Plain & EDTA tube for maternal blood collection
  • Client ID labels so that the contents are not mixed with other samples with different kits being used for twins and triplets
  • Pair of gloves
  • Sample collection form.

The collection kit also includes Paramedic kit which contains:

  • Alcohol swabs for cleaning of the cord & sterile gauze pieces for covering cord blood bag, zip lock bags to avoid leakages and contamination, 2 pairs of gloves, sterile drape.
  • Nursing team kit components
    • Gloves and other requirements
  • Documentation
    • Sample collection form with Doctor's authorization
  • Data Logger (for all samples) to track real time temperature.
  • GPS Tracker (for special packages and optional services).

Shipping Info

Biocell® makes shipping arrangements on behalf of the parents anywhere in India at no extra cost. The paramedic or nurse of the facility picks up the cord blood sample from the hospital and passes it on to the logistics partner. Biocell® uses a network of logistics companies that provide biological shipment such that services are available 365x24x7.  Biocell® has tied up with leading cold chain and logistics companies like BlueDart, TNT, Sequel Logistics etc. to ensure we are present across 600 cities within India and 35 other countries like Bangladesh, Euthopia, Vitenam, Dubai, Canada, the US, New Zealand, around the globe.

Processing Method

Biocell® uses the optimal manual processing method of double sedimentation and spin technology allowing maximum cell recovery. Cryopreservation chambers are completely secured with double bar-coded identification system.

Components Stored

Biocell® provides parents with a certificate describing test results as follows:

  1. CD 34+ cell count
  2. Total Nucleated Cell (TNC) count
  3. Cell Viability
  4. Colony Forming Unit (CFU) assay to know the proliferation capacity of stem cells stored. Biocell® is the only cord blood bank that performs this test at the time of preservation.
  5. Mono Nuclear Cell (MNC) count
  6. Sterility test
  7. HLA (at the time of retrieval)
  8. HPC profiling
  9. CD133+ cell count – Exclusively done by Biocell® in India.
  10. Maternal blood test including:
  • Blood grouping & Rh typing
  • HIV I and II
  • HBSAg
  • HTLV I and II
  • CMV IgM, IgG
  • Malaria
  • Syphilis
  • Anti- HCV
  • Anti- HBC

Storage Method

Final storage of cord blood components is done in cryo-bags and encased in over wrap bags. The bag is cryopreserved for temporary storage in a quarantine tank, then transferred to a tank for long term cryopreservation after it passes all quality control checks. The cryopreservation is under vapor phase of cryogenic nitrogen.

Licensing & Accreditation

Biocell® is licensed and certified by the following national and international organizations.

  • Licensed by the Indian Food and Drug Authority (FDA), 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).
  • Good Manufacturing Practices (GMP) certified by FDA, CDSCO and British Standard Institution (BSI).
  • Good Laboratory Practices (GLP) quality control testing from BSI.
  • Good Clinical Practices (GCP) from BSI.
  • BSI is recognized by World Health Organization (WHO) and hence samples are acceptable worldwide.

Clinical Experience

Biocell® facilitated India’s first cord blood transplantation 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.

Biocell® has also adopted a community sharing program (without need to give up the rights of the sample), called hybrid banking. Biocell® has facilitated its first transplant through hybrid banking service for a patient with Cyclic Neutropenia. The stem cells were donated from an existing client to an unrelated patient.

Insurance

Biocell® Quality Assurance: If the umbilical cord blood unit cannot be used for the child and/or member of family for the hematopoietic cord blood stem cell transplantation for the reasons stated under this program, then the bank will provide another umbilical cord blood unit to the client. In case of failure to provide another umbilical cord blood unit, the bank will provide an amount not exceeding INR 20 Lakhs to the client. This is subject to meeting the requirements and other conditions as mentioned in the agreement.

Community Service

Biocell® Philanthropy Program: If the child or its sibling or either of its genetic parents requires hematopoietic cord blood stem cell transplantation, the bank offers monetary support to cover actual expenses or INR 20 Lakhs, whichever is less, subject to meeting the requirements and other conditions as mentioned in the agreement.

Prices

Biocell® offers plans with fees ranging from 79,000 INR to 1,99,000 INR. Our sales and education teams can provide teleconference, video conference, personal face to face interactions to share more information. To know more, visit https://biocell.in/ or https://www.regrow.in/ or phone Toll Free 1-800-209-0309.

Additional Services

Biocell® offers the following additional services:

  • Hemoglobinopathy Testing - Checks for any abnormal forms of hemoglobin in the cord blood.
  • CCHD (Critical Congenital Heart Diseases) - Non-invasive screening (sensor-based technology) to detect the disease.
  • CFU Assay - Predicts the potency and differentiation capacity of the stem cells.
  • HLA Typing - Helps to identify the closest matching sample for transplant.
  • Data Logger - Tracks the real-time temperature of the collection kit during transit.

Prices with Additional Services

Biocell® has several additional services that offer cell therapy (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. The company has partnered with more than 350 hospitals like Apollo, Max, Fortis etc. to enable patients to access these therapies.

Address: 2-ABC, ACME Plaza, Andheri - Kurla Rd, Andheri East, Mumbai, Maharashtra 400059, India