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Family Bank: Vita 34

About

Vita 34 is the most experienced and largest private stem cell bank in the German-speaking countries and the second largest private umbilical cord blood bank in Europe. Founded in 1997, Vita 34 was the European pioneer in the field of private umbilical cord blood banking, and has stored more than 200,000 stem cell deposits for families from Germany and 28 other countries.  Moreover stem cells stored at Vita 34 have been applied in medical therapies 30 times already – a proof for the high quality of storage at Vita 34.

Labs and Locations

Vita 34 has two state-of-the-art laboratories in Germany which operate exclusively in line with the highest medical quality standards (GMP – Good Manufacturing Practice) and which are monitored by German authorities. The in-house quality assurance monitors the overall GMP compliance of the processes in the ultra-modern clean room laboratory and the storage in the cryo-tanks. This way, Vita 34 ensures quality and safety on the highest level for decades.  The special laboratory at Vita 34’s headquarter in Leipzig was the world’s first glass laboratory and can be viewed on tours.

Business Experience

Vita 34 has more than 20 years of experience in the field of stem cell banking and is also sharing the experience with other firms worldwide. Currently Vita 34 is active in more than 20 countries in Europe and worldwide via subsidiaries and cooperation partners.

Especially in Europe Vita 34 has established a distribution alliance in most parts. Stem cells from both subsidiaries and distribution partners are processed and stored centrally in Germany. The Vita 34 partner in each country is responsible for all steps and procedures until the samples are received by Vita 34. This includes marketing and distribution, the training of the hospital staff, all the communication with the customer as well as the transport of the cord blood/cord tissue samples to Vita 34. Together with its partners, Vita 34 works together with about 2,000 maternity institutions and more than 15,000 obstetricians.

In terms of medical applications, Vita 34 is leading in Europe. In case of an application Vita 34 undertakes all necessary prearrangements – from additional tests in the laboratory via transportation of the cord blood to the place of transplantation up to the preparation on the ground. Therefore Vita 34 has developed a tailor-made transplantation logistic and established – as a forerunner in Europe – the first mobile stem cell team. Thus, treatment while observing the highest standards of quality is possible in any hospital.

In order to study the potential applications of UCB stem cells and to develop new cell products, Vita 34 is working together with renowned research institutes and universities, and actively participating in applied stem cell research.

Collection Kit

In order to ensure top quality, Vita 34 developed many tools itself in accordance with top standards: The Vita 34 collection bag for umbilical cord blood called “Entnahmeset Vita 34” has a special designed foil for better survival of blood cells during transportation as well as a back-eye needle with higher diameter to collect higher volumes of blood. Moreover the collection set contains a lower CPD (anti-coagulant) quantity for higher survival of stem cells in samples with low volume. The collection bag is sterile both inside and outside so that it can be used in an operating room during C-section. The bag is validated and accepted by the Paul-Ehrlich-Institute (Federal Authority for Vaccines and Biomedicines in Germany).

Transportation container

The cord blood (and the cord tissue) are transported in a thermally insulated shipping box designed by Vita 34: The transportation box is validated and tested to maintain room temperature under test conditions.  In Germany transport temperature of 18-26° Celsius is mandatory. Therefore the box contains large gel packs to stabilize the temperature and a data logger to monitor shipping conditions. Vita 34 pioneered the use of temperature loggers in cord blood transport.

Shipping Info

For all shipping arrangements, Vita 34 or the distribution partner are responsible. After the birth of the baby the clinic informs the courier via 24 hours hotline. The courier transports the blood (and tissue) safely packed to the Vita 34 laboratory, where further steps on the way to stem cell storage deposit are taken. Standard shipping within Germany is by “Der Kurier” – trained by Vita 34 for a safe transport within 24 hours. The courier service is available 24 hours 7 days a week.

Processing Method

Vita 34 is able to offer the storage of cord blood via 3 different processing methods: Vita 34 has the permission for the professional production of pharmaceuticals as whole blood, and as separated stem cells via either SEPAX or AXP processing equipment. The processing method depends on the respective country. In Germany all samples are stored as whole blood.

Components Stored

Reports: Parents are provided with a storage certificate detailing their unique identity code, name and date of birth of the mother as well as date and time of birth of the child. The clients are also provided with all test results from cord blood and maternal blood (e.g. virus antibodies, cell counts, bacterial contamination, blood type).

Storage Method

The storage tanks used by Vita 34 are completely independent from electric power supply. They are thermo tanks made of stainless steel. They contain a reservoir of -196° C cold liquid nitrogen on the bottom. The samples are stored in the vapour nitrogen layer above. The advantage of this storage method in contrast to cooling with liquid nitrogen is that any cross-contamination between cord blood units is impossible.

The final storage is in a proprietary cryo bag developed by Vita 34. The bag has a very high break strength, is very cold-resistant and so ideal for long-term storage. Together with the cryo bag, 5 aliqouts are stored. This allows taking only a small quantity and examining it before an application event. The main preparation remains untouched. For perfect protection the cryo bag and the vials are encased in a very stable metal freezing cassette.

Licensing & Accreditation

Vita 34 has all required state authorizations and certifications. Moreover Vita 34 is the only private umbilical cord blood bank in Europe that has permission from the German Federal Institute for Immunizations and Biomedical Pharmaceuticals (Paul Ehrlich Institute) for the production and distribution of autologous and allogenic preparations and that can offer the preparation of stem cells via 3 different processes. Further Vita 34 is the only private stem cell bank in the German speaking countries that has a permit for the collection, processing, cryopreservation and storage of umbilical cord tissue.

All preparations are produced in line with good manufacturing practice (GMP) and are of certified quality. Since 2018 Vita 34 is also FACT accredited.

All licenses and accreditations are listed below:

Description

Number

Permission for the professional production of pharmaceuticals (preparation and cryopreservation of cord blood for autologous and allogenic application, also with reduced volume – SEPAX and AXP process)

DE SN 02 MIA 2012

0019/24-5463.10/36/1 autologous

allogeneic

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: 2007 007694 23

Cord Blood Vita 34 – 2,5 allogenic

PEI.H.00601.02.1

Cord Blood Vita 34 – 5 allogenic

PEI.H.00601.01.1

Cord Blood Vita 34 Mini allogenic

PEI.H.00601.03.1

Cord Blood Vita 34 – 1 directed allogenic

PEI.G.04318.01.1

Cord Blood Vita 34 – 2 directed allogenic

PEI.G.04318.02.1

Autologous cord blood VITA 34-1 (-2/3)

[Autologes Nabelschnurblut VITA 34-1 (-2/3)]

PEI.G.03988.01.1 (02.1)

Permission for the collection, preparation, cryopreservation and storage of cord tissue according to § 20b and §20c AMG (German Medicines Act)

GE 006/2013/24-5463-50/178

Permission for the collection of cord tissue in Austria according to § 19 (2) GSG (Tissue Safety Act)

INS-680185-0003-009

Permission to import cord tissue from Switzerland according to § 72b AMG

GE 006/2014 24-5463-50 178

GMP Certification

DE_SN_01_Blut_2017_0005

FACT Accreditation

 

US FDA Registration

 

Clinical Experience

§ Number of all cord blood collections released for all therapy: 31
§ Number of family cord blood collections released for autologous therapy: 21
§ Number of family cord blood collections released for directed allogenic: 8
§ Number of family cord blood collections released for allogeneic therapy: 1
§ Number of public cord blood collections released for allogeneic therapy: 2


§  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

Insurance

Vita 34 was the first cord blood bank in the world to provide parents bankruptcy insurance. This unique security is an integral part of the service. In case of an insolvency the insurance guarantees that the child’s stem cell preparation will be stored professionally until the 50th birthday.

Community Service

  • Sibling Initiative
    Since 2002, Vita 34 offers parents of children suffering from diseases which are currently treatable by allogenic stem cells a cord blood storing for their newborn for five years at no extra charge. Cord blood stored with Vita 34 has been used for siblings several times already.
  • VitaMine&Yours
    VitaMine&Yours combines the storage of umbilical cord blood for individual healthcare and the storage of umbilical cord blood for the purpose of public donation. If the quantity is sufficient, two fully-fledged stem cell deposits will be stored, one privately and one donated publicly. Parents pay only the fees for the storage of their child’s stem cell deposit.
  • VitaPlusDonation
    VitaPlusDonation means autologous storage with the option to donate the whole cord blood in case a foreign person needs it. If a suitable recipient needs these stem cells, the doctor in attendance will ask the parents via Vita 34. Vita 34 release the umbilical cord blood for treatment only when the parents give their consent. Vita 34 will reimburse the fees paid so far for VitaPlusDonation plus interest.

Disclaimer: Not all services are available in all countries

Prices

Prices may differ from country to country.
Vita 34 offers the following packages in Germany.

Store umbilical cord blood
VitaPlus:       €1,990 initial cost (collection set + collection + courier + processing + testing) and €48.20 annual storage fee
VitaPlus25:  €2,595 initial cost including first 25 years of storage (Discount: €600)[1] and €48.20 annual storage fee from the 26th year
VitaPlus50:  €3,500 initial cost including first 50 years of storage (Discount: €900)[1] and €48.20 annual storage fee from the 51th year
Various payment plans (starting with 3.5% interest, only in Germany) available

Store umbilical cord blood and tissue
VitaPlusCord:       €2,490 initial cost (collection set + collection + courier + processing + testing) and €72.20 annual storage fee
VitaPlusCord25:  €3,395 initial cost including first 25 years of storage (Discount: €900)[1] and €72.20 annual storage fee from the 26th year
VitaPlusCord50:  €4,800 initial cost including first 50 years of storage (Discount: €1300)[1] and €72.20 annual storage fee from the 51th year
Various payment plans (starting with 3.5% interest, only in Germany) available

Notes: [1]compared to annual mode of payment for “VitaPlus” or “VitaPlusCord”

Additional Services

Vita 34 offers the following additional services in Germany.

  • Preventive Screening Test (+€390)
    The preventive screening include DNA testing for e.g.:
    • Drug-induced hearing loss (antibiotics intolerance)
    • AAT deficiency (dysfunction of immune system)
    • Lactose intolerance
    • Gluten intolerance (cereal flour intolerance)
  • VitaPlusDonation:
    VitaPlusDonation means autologous storage with the option to donate the whole cord blood in case a foreign person needs it. In this case, parents get their money back.
  • VitaMine&Yours:
    VitaMine&Yours combines the storage of umbilical cord blood for individual healthcare and the storage of umbilical cord blood for the purpose of public donation. If the quantity is sufficient, two fully-fledged stem cell deposits will be stored, one privately and one donated publicly. Parents pay only the fees for the storage of their child’s stem cell deposit.
  • Transport of the umbilical cord blood to the treatment center
    If the family needs the cord blood for medical treatment, the mobile stem cell team of Vita 34 transports the cryo-preserved umbilical cord blood in a special container to the treatment center at no extra charge within Germany and Austria.
  • Family support
    If the umbilical cord blood is applied within the scope of a cancer therapy in the first 20 years of the child’s life, Vita 34 will grant the parents a one-time payment of €7,000. The money can be used irrespective of the therapy costs covered by your health insurance.
Address: Deutscher Platz 5, 04103 Leipzig, Germany