Every year approximately 6,000 people in Germany, many of them children or youths, are diagnosed with leukemia or another malignant blood disease. For many of these people, the only hope for life lies in a transfusion of blood stem cells. This is because chemotherapy not only kills the malignant cells in the bone marrow, but also the healthy cells. In addition to bone marrow donations, there has been for some time another alternative for acquiring stem cells, a method that is significantly more gentle for the donor. This method uses a substance that for hundreds of years had been discarded as waste after childbirth, namely umbilical cord blood (UCB). The interplay of science and technology can be clearly seen in the example of the Freiburg-based firm of CellGenix.

Metron, a wholly-owned subsidiary of CellGenix, manufactures and processes stem cell products from UCB, and operates one of six public UCB banks that manage inventories of stem cell products made from UCB. The company, founded in 1994, is a spin-off from the University of Freiburg, and works together closely with hematologists at the Freiburg University Clinic. The “suppliers” are the gynecological departments of 19 hospitals in Baden-Württemberg, who must meet stringent requirements and whose personnel must receive training at regular intervals. The process works like this: If a pregnant woman agrees prior to the birth of the child to make a donation of UCB, then data relevant for the donation (prior illnesses, immunisations, lifestyle habits, etc.) are acquired through a questionnaire. This is just the starting point. In practice, a majority of potential donations are already ruled out at this stage because of the high quality requirements.

The birth occurs normally, and the immediate care of mother and child following the birth is not influenced by the impending withdrawal of UCB. Approximately three to five minutes after the birth, 60ml to 180ml of blood is transferred from the umbilical cord directly into special collection bags, and is transported to CellGenix via courier in a validated transportation system. The blood arrives no later than 24 hours later.

There the usability of the UCB is first tested, i.e. HIV, hepatitis, blood diseases, etc. are ruled out. Only then do the specialists begin to process the specimen. Small reserve samples are drawn from the specimen, and the UCB is divided into stem cell, plasma, and erythrocyte fractions. The UCB contains only 1% to 5% stem cells. The stem cell product is then deep-frozen at -196°C. CellGenix can document a shelf life of eight years for its specimens. According to Dr Stefan Thoma, head of Cell Therapeutics at CellGenix, experience with bone marrow transplants has shown that storage over 20 years or more is possible.

Hand in hand with high-performance technology

When preparing its stem cell products, Metron relies on BINDER incubators. Tuttlingen-based BINDER GmbH is a specialist in simulation chambers and has many years of experience in the scientific sector. Its products are used wherever absolute reliability and extreme precision are required, for example in areas such as in vitro fertilisation, stem cell research and acquisition, and tissue engineering.

The CellGenix laboratories currently have 36 CB150 incubators in service. These incubators meet the demanding requirements of this work using just their standard configuration. For example, at the push of a button they can perform hot-air sterilisation overnight at 180°C. The CO2 incubators have highly dynamic CO2, temperature, and humidity parameters thanks to BINDER’s patented Permadry system and the APT.line air jacket system, which ensures condensation-free walls. Even in its designs, BINDER makes full use of the advantages offered by its advanced production features. The seamless, deep-drawn stainless steel inner chamber contains no troublesome projections or edges that could be potential sites of contamination. The interior is also completely free of condensation. This design increases usable space and reduces the effort required for manual cleaning.

Standard equipment for the BINDER CB150 units includes high-performance technologies such as IR sensors for selective real-time measurement, a gas-mixing nozzle with Venturi effect, and a high-quality program controller.

UCB donations help to save lives

Patients who require a stem cell donation need donors whose tissue characteristics match those of the recipient. This is why donors often come from the recipient’s own family. Tissue characteristics are also analysed and recorded in the UCB banks for stem cell products made from UCB. It is known that stem cells acquired from UCB have greater immunological flexibility, and that rejection responses are rarer and less severe. Moreover, in contrast to blood marrow donation or peripheral blood stem cell donation, umbilical cord blood donation is the only method that does not involve any stress or strain for the donor or the recipient.

The market for these stem cell products is highly competitive. Private UCB banks offer parents the opportunity to store the blood of their own child as a sort of “reserve” in the event that it is needed at any time. This is relatively expensive. The physicians at the Freiburg University Clinic and the specialists at CellGenix, on the other hand, support the idea of donation. A situation in which a couple’s own child would need stem cell products is rather rare, and even if this were to occur, one could always use products made from third-party blood. By contrast, a donation of umbilical cord blood always helps a sick person.