Vita 34 AG
AboutVita 34 was the first family cord blood bank in Europe and is the leader in Europe for the number of cord blood therapies from private storage. Vita 34 operates to such high standards that they are able to offer a public donation option in addition to family storage of cord blood.
Bank Locations:Vita 34 - Switzerland (Leipzig), Vita 34 - Austria (Leipzig), Secuvita (Madrid), Izvorna Celica (Maribor), Vita 34 - Austria (Vienna), Vita 34 - Switzerland (Basel), Vita 34 - Bosnia (Sarajevo)
Business ExperienceVita 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 for transplantation in a person other than the donor (allogeneic transplant).
Vita 34 inventory as of Jan. 2011 is 80.000 CB stored, both autologous and allogeneic.
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.
§ 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 CB 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)
- Infantile brain disease
- Diabetes Mellitus Type 1
- Tissue engineered heart valves
- 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
Number of family cord blood collections released for all transplants: 21
Number of family cord blood collections released for autologous therapy: 17
Number of family cord blood collections released for allogeneic therapy: 4
§ 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 CB is used for a foreign patient in the VitaplusDonation program
§ If the family needs the CB for medical treatment, Vita 34 stem cell team will transport it to a hospital within Germany for free.
§ If the family needs the CB 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.
§ Vita 34 Classic: €1.990,00 initial cost (collection set + collection + courier + processing + testing) and €43,70 annual storage fee
§ Vita 34 Compact 25: €2.590,00 initial cost including first 25 years of storage (Discount: €492,50) and €43,70 annual storage fee from the 26th year
§ Option of €690,00 initial cost and €8,00 monthly storage fee
§ Various payment plans (starting with 0% interest or €19,98 per month) available
§ Newborn genetic testing (+€400)
§ 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.