Official licenses and permits

Securing the stem cells is good - applying stem cells is even better!

Vita 34 owns comprehensive permits, licenses, concessions, and accreditations.

The compliance with the strictest quality standards is reflected in the various permits and licenses. In addition to the license concerning the autologous release of umbilical cord blood, Vita 34 is the only private stem cell bank in Germany that owns the following licenses:

  • Licenses issued by the German Federal Institute for Vaccines and Biomedicines (Paul Ehrlich Institute) concerning the release of umbilical cord blood preparations for therapeutic application in case of hematologic-oncological diseases for siblings and in order to help other people by means of donation
  • License to collect, process, cryo-preserve, and store umbilical cord tissue in Germany, Austria, and Switzerland (DACH region)
  • Licenses to offer customers the storage of whole blood and separated blood.

This comprehensive range of licenses and permits helps Vita 34 to create the requirements to enhance the range of services and products constantly for our customers.

 Type of License  Description
Manufacturing license pursuant to §§ 13, import license pursuant to §§ 72 AMG Collection and import license issued by Saxon State Directorate (Landesdirektion Sachsen)
Manufacturing (Deutscher Platz 5a), §13 AMG (medicinal products for human use) Stem cells from umbilical cord blood, autologous and allogeneic blood, cryo-preserved, includes volume reduction (SEPAX method)
Import license, § 72 AMG human cord blood from autologous blood (Switzerland/Serbia)
Manufacturing of investigational medicinal products, §13 AMG  Stem cells from umbilical cord blood – autologous blood cryo-preserved for clinical investigation (limited to diabetes study, which is concluded already)
Storage of preparations  
Storage of preparations  
Manufacturing license pursuant to §§ 20b, 20c, 72b AMG License to collect tissue, process and prepare, preserve, and store tissue as well as import tissue
Collection of tissue, § 20b AMG Human umbilical cord (autologous)
Processing and preparation, preservation, and storage of tissue, § 20c AMG Human umbilical cord (autologous)
Import license, § 72b AMG Human umbilical cord (autologous, Switzerland)

In addition to the manufacturing/import license pursuant to §§ 13 and 72 AMG (German Medicinal Products Act) and the license to collect tissue, process and prepare, preserve, and store tissue as well as import tissue pursuant to §§ 20b, 20c and 72b AMG and the related GMP certificate, Vita 34 AG owns permits and licenses issued by Paul Ehrlich Institute.

License as drug product
(allogeneic donation) pursuant to § 21 AMG
Licenses and permits issued by Paul Ehrlich Institute
License no. / initial date of license (extension of license on April 13, 2015)
Cord Blood VITA 34 – 2.5 PEI.H.00601.02.1 / October 14, 2006
Cord Blood VITA 34 – 5 PEI.H.00601.01.1 / October 14, 2006
Cord Blood VITA 34 mini PEI.H.00601.03.1 / December 20, 2007

 

License on the application as directed donation pursuant to § 21a AMG

Permits and licenses issued by Paul Ehrlich Institute
License no./license date

Cord blood VITA 34-1 directed – allogeneic PEI.G.04318.01.1 / August 2, 2011
Cord blood VITA 34-2 directed – allogeneic PEI.G.04318.02.1 / August 2, 2011

 

License on the application as autologous preparation pursuant to § 21a AMG

Permits and licenses issued by Paul Ehrlich Institute
License no./license date

Autologous cord blood VITA 34-1 PEI.G.03988.01.1 / January 12, 2012
Autologous cord blood VITA 34-2/3 PEI.G.03988.02.1 / January 12, 2012

 Furthermore, cord blood Vita 34 was licensed as investigational medicinal product for the study on diabetes type 1 conducted by the University of Munich (ClinicalTrials.gov identifier: NCT00989547).

Manufacturing license pursuant to the Austrian Tissue Safety Act (GSG)

Collection licenses issued by the Austrian Agency for Health and Food Safety (AGES) / date)

Manufacturing license §19 (1) GSG Collection of autologous umbilical cord blood / April 28, 2011
Manufacturing license § 19 (2) GSG Expanded by collection of umbilical cord tissue / September 17, 2013
Manufacturing license § 19 (2) GSG Expanded by collection of umbilical cord blood for allogeneic application / September 2, 2014