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StemSure
About
Parent bank: BebéVidaBusiness Experience
BebéVida, with almost 20 year’s experience in processing and storing biological products, has released 2 biological products for clinical use. Besides the cord blood and cord tissue, BebéVida processes other biological products for clinical use. One of the examples is the Platelet Gel used in orthopedic surgery. BebéVida also offers Babysafe to pregnant women, which is a non invasive pre natal test (NIPT) to detect some abnormalities in the fetus.
Bio-Cord of Spain owns a share of BebéVida since 2018. Bio-Cord belongs to the Cerba Internacional group of clinical laboratories in Europe. The group has more than 1.000 employees, and performs up to 20,000 clinical analyses per day.
Collection Kit
The collection kit used by BebéVida is approved by INFARMED, the National Authority for Medicines and Health Products, as a medical device. The collection kit is validated for shipping biological samples from hospitals to the laboratory.
Transportation Container
All the BebéVida collection kits are monitored in terms of temperature to guarantee that the samples are shipped in a predefined range of temperature. The collection kit complies with UN3373 directives to be shipped by car and by plane./p>
Shipping Info
Each individual sample of Cord Blood and Cord Tissue is transported by specialized courier in a temperature controlled package. Shipping and processing are in operation 365 days a year.
Processing Method
All the processing is performed in clean rooms to ensure maximum sterility of the samples and to prevent contamination. Prior to 2022, BebéVida used fully automated processing technology. Nowadays, BebéVida is processing cord blood in a closed semi-automatic system. With the experience of our lab team, we are able to process cord blood ensuring the highest TNC recovery rates without compromising the contamination rate.
For clients of Bio-Cord in Spain, there are two options for storage of cord tissue: either fragmented umbilical cord tissue or isolated Mesenchymal Stromal Cells (MSC).
Components Stored
The BebéVida laboratory separates and stores the cord blood stem cell enriched fraction of the blood via a volume reduction method that reduces red cells and plasma content. Biological products need to comply with pre-defined criteria in order to be stored. At the end of all processing activities, the Medical Director sends a report to Parents with information about cord blood volume collected, TNC prior processing, TNC prior cryopreservation, the CD34+ enumeration, total cellular viability, blood group, the sterility test and viral test done in maternal blood.
Storage Method
Bebévida uses vapor phase cryogenic tanks to store cord blood and cord tissue units at a temperature below -170 degrees. Tank temperature is monitored at all times, with an alarm system for warming events, ensuring safety for all biological products. Blood samples are stored in bags inside aluminum canisters with overwrap and tissue samples are stored in cryovials.
Licensing & Accreditation
- Direção Geral da Saúde - Portuguese Health Authority (processing and storage activities)
- IPST - Instituto Português do Sangue e da Transplantação (Import and export samples from other countries)
- INFARMED - National Authority for Medicines and Health Products (collection kit as a medical device)
- AABB accredited (Cord blood and cord tissue)
- FACT Accredited (Cord blood)
Clinical Experience
BebéVida has released 2 biological products for therapeutic use.
Guarantees
BebéVida has an insurance of 60 millions EUR to support the costs of any damages in biological samples.
Prices
- Payment Plans are available upon request.
- Special prices are possible with some health insurance partners.
- Discounts given for twin pregnancies.
Additional Services
Bio-Cord Services are offered in three tiers:
- FIRST: Our standard service for storing cord blood stem cells.
- ADVANCED: First Service + Fragmented umbilical cord tissue. In this option we conserve the blood stem cells as in First service and additionally we conserve the umbilical cord tissue fragmented into small pieces. If therapy with cord tissue cells becomes necessary, treatment will require further laboratory processing to remove the mesenchymal stromal cells (MSC) from the tissue and culture them to grow the cell number.
- PROFICIENCY: Advanced Service + Cells isolated from cord tissue. This new service preserves the stem cells of the blood and the mesenchymal stromal cells (MSC) of the umbilical cord tissue. The tissue MSC are extracted through a process of enzymatic digestion, followed by cell culture to grow the cell number. This is the most complete method possible at present. This way we can quantify the tissue cells that have been extracted and will be ready to be used in the future.