Bio Save (Vita 34) - Romania
AboutParent bank: Vita 34
Bio Save company is the exclusive representative in this country of the
first family stem cell bank in Europe, Vita 34, which is situated in
Leipzig, Germany. Vita 34 operates under the strict medical procedures
and regulations of EU, and as a confirmation of the high quality of
storage and processing, it was the first stem cell bank to receive GMP
certificate. The cord blood samples from Vita 34 have been used for the
treatment of more children than all the family stem cell banks in Europe
put together. Vita 34 holds quality above all other standards,
especially in ensuring the possible future use of stem cell sample.
Vita 34 was founded in April 1997 and has been banking cord blood (CB) since Nov. 1997. Vita 34 received the license to "manufacture" CB in their own lab in Oct 1997. Vita 34 received Paul-Ehrlich-Institute drug approval in 2006 that allows the release of CB to transplant a person other than the donor (allogeneic transplant).
The company has the permission for the production and distribution of autologous and allogenic preparations through European Subsidiaries and partners (eg in Spain, Italy, Austria, Slovakia, Lithuania, Balkan states) as well as strategic alliances worldwide (eg Chile, Mexico, Vietnam). Thanks to the existing sales and marketing alliance in the Balkans we cover Slovenia, Serbia, Montenegro, Macedonia, Bosnia-Herzegovina, Romania, Bulgaria and Croatia.
Moreover Vita 34 is involved in stem cell research together with renowned research institutes and clinics, in order to study the practical and medical possibilities for using umbilical cord stem cells, or for developing new cryotechnology stem cell products.
In Jan. 2014, Vita34 took over a 75.24% stake in their competitor Stellacure, further consolidating their dominance of the German market.
At Vita 34, the staff of the bank answers phone calls.
§ Brand name bag: “Entnahmeset Vita 34”
§ Bag is sterile inside & outside for C-Section use
§ Proprietary bag, validated and accepted by the Paul-Ehrlich-Institute
§ Special disinfection kit supplied with the set
§ CPD used as anti-coagulant
§ Container has large gel packs and thermal insulation.
§ Container is validated and tested to maintain room temperature under test conditions. German TueV tested. In Germany transport temperature of 18-26° Celsius is mandatory.
§ Container includes a temperature logger. Vita 34 pioneered the use of temperature loggers in cord blood transport.
§ Shipping arrangements are made by the bank. Clinical staff informs Vita 34 via 24 hour hotline.
§ Contract price includes shipping for Germany, Austria, and Switzerland.
§ Standard shipping is by “Der Courier” – trained by Vita 34 for safe transport within 24 hours. The courier service is available 24 hours 7 days a week.
§ Whole blood storage - no cell separation, no plasma depletion, no loss of cells.
§ Storage of umbilical cord tissue
§ Parents are provided with a certificate describing all test results from cord blood and maternal blood (e.g. virus antibodies, cell counts, bacterial contamination, blood type)
§ Storage of whole blood plus 5 testing samples in the same cassette.
§ Storage in the vapor phase of liquid nitrogen. Tanks are provided by MVE/Chart, Inc.
§ Final storage is in a cryo bag (proprietary bag developed by Vita 34 for high breakage protection).
§ 5 testing portions are stored in vials.
§ Storage bag and vials are encased in a metal cassette.
Licensing & Accreditation
§ Vita 34 is licensed to manufacture autologous and allogeneic cord blood samples in Germany
§ Vita 34 has a European Union GMP certificate
§ German Drug Law approvals:
o Drug approval by Paul-Ehrlich-Institute for the allogeneic use of cord blood:
§ Cord Blood VITA 34 - 2,5 (PEI.H.00601.02.1)
§ Cord Blood VITA 34 - 5 (PEI.H.00601.01.1)
§ Cord Blood VITA 34 mini (PEI.H.00601.03.1)
o Paul-Ehrlich-Institute allowance:
§ Directed allogeneic donation:
Nabelschnurblut VITA 34 – 1/ - 2 (gerichtet allogen) G.04318.01.1
§ Homologous transplantation for hematopoietic reconstitution
Nabelschnurblut VITA 34 (autologous) G.03988.01.1
§ Non-homologous transplantation (ATMP: Advanced Therapy Medicinal Products)
o Infantile brain disease
o Diabetes Mellitus Type 1
o Tissue engineered heart valves
o Post mycardial infarction
§ Approval by Paul-Ehrlich-Institute (PEI) to use Vita 34’s Cord Blood in study: "Transfusion of autologous Umbilical Cord Blood to Reverse Hyperglycemia in Children with Type 1 Diabetes" EudraCT-Nr.2007-007694-23
§ Establishment registration and listing for human cells, tissues, and cellular and tissue-based Products, Vita 34 AG - FEI: 3004141298 (US Clinics by NMDP cord blood registry is applicable institution)
§ US Food and Drug Administration: BLA (Biologics license application), IND (Investigational New Drug) for allogeneic Cord Blood is in process
§ Vita 34 has permission for the preparation, cryopreservation and storage of cord tissue According to § 20c AMG (German Drug Law) and for the collection of cord tissue according to § 20d AMG
§ Vita 34 has permission for the collection of cord tissue in Austria according to § 19 (2) GSG
Number of family cord blood collections released for all transplants: 30
Number of family cord blood collections released for autologous therapy: 20
Number of family cord blood collections released for allogeneic therapy: 10
§ Vita 34 also collects cord blood donations for the public.
§ Vita 34 participates in the Diabetes Type 1 clinical trial of the Technical University of Munich - ClinicalTrials.gov Identifier: NCT00989547
§ Vita 34 was the first bank in the world to provide parents bankruptcy insurance: it covers 50 years of storage.
§ Vita 34 will refund parents theirs costs, if the cord blood is used for a foreign patient in the VitaplusDonation program
§ If the family needs the cord blood for medical treatment, Vita 34 stem cell team will transport it to a hospital within Germany for free.
§ If the family needs the cord blood for cancer treatment, Vita34 pays €5.000 unrestricted Family Support.
§ Vita 34 provides FREE stem cell banking to families where a sibling of the newborn has a diagnosis for which stem cell transplantation is standard therapy.
§ VitaplusDonation program gives parents who qualify the option to have the cord blood typed and listed on a registry for patients who need matching transplants.
Store umbilical cord blood
§ VitaPlus: €1.990,00 initial cost (collection set + collection + courier + processing + testing) and €48,20 annual storage fee
§ VitaPlus25: €2.595,00 initial cost including first 25 years of storage (Discount: €600) and €48,20 annual storage fee from the 26th year
§ VitaPlus50: €3.500,00 initial cost including first 50 years of storage (Discount: €900) and €48,20 annual storage fee from the 51th year
§ Various payment plans (starting with 0%) available
Store umbilical cord blood and tissue
§ VitaPlusCordTissue: €2.490,00 initial cost (collection set + collection + courier + processing + testing) and €72,20 annual storage fee
§ VitaPlusCordTissue25: €3.395,00 initial cost including first 25 years of storage (Discount: €900) and €72,20 annual storage fee from the 26th year
§ VitaPlusCordTissue50: €4.800,00 initial cost including first 50 years of storage (Discount: €1300) and €72,20 annual storage fee from the 51th year
§ Various payment plans (starting with 0%) available
§ Newborn genetic testing (+€390)
§ VitaplusDonation: allogeneic storage with the option to donate the CB in case a foreign person needs it (+€0 Euro). In this case parents get their money back.