Providing even faster help to patients with Adult Donor Cryopreserved Units (ADCUs)

For many patients, the search for a donor is the beginning of a race against time. The faster a suitable donor is identified and the faster the hematopoietic stem cells reach the patient, the better the chance of survival. This urgent need was the initial motivation for extending our activities to process, store, and deliver Adult Donor Cryopreserved Units (ADCUs) in addition to the procurement of cord blood units. These ADCUs are derived from peripheral hematopoietic stem cells from unrelated volunteer adult donors who are already in the collection process for a specific patient (directed donation).

In our experience, many donors mobilize considerably more stem cells than a single patient actually needs (collected cells in relation to the requested CD34-positive cell count). Thus, these additional cells are collected by apheresis from a volunteer adult donor in the course of a directed donation. The additionally obtained cells are processed into an ADCU, stored in our DKMS Stem Cell Bank, and can be made available to the next patient in need - the donor can save two lives with just one donation.

Advantages of ADCUs for patients

The donor’s availability and the duration from request to transplantation are crucial aspects of unrelated hematopoietic stem cell transplantation. Our DKMS Stem Cell Bank provides cryopreserved stem cell products off the shelf to minimize time to transplant.

For patients, this means a significantly shorter time to transplantation, which can improve the chances of success, as the patient’s health can deteriorate while waiting for the transplant, ultimately – making transplantation impossible in some cases. As the donation will already have taken place, our DKMS Stem Cell Bank’s cryopreserved product is promptly available. There is no need to activate the donor. The process of the preliminary examination and donor clearance will also already have taken place.

The desired delivery date can be freely chosen by the transplant center. When time is short, our team at the DKMS Stem Cell Bank laboratory requires a minimum of three days between the initial request and transportation to the clinic. The transportation can take up to one or two days.

• This allows much better planning for the conditioning of the patient.
• The product specifications and quality are known.
• Our team at the DKMS Stem Cell Bank checks the quality and ensures that the product is intact before shipping.
• Listed ADCUs have a 100% availability, they are immediately accessible and ready-to-use for transplantation.

ADCUs are already available for search and request via the DKMS Registry. They will become available via the WMDA Search & Match Service by the end of 2024.

Transplant centers and search units in Germany continue to search via the German National Bone Marrow Donor Registry (ZKRD), which also informs them about suitable ADCUs.

In cases where a cryopreserved product is requested and the donation took place more than six months ago, the donor will be contacted in order to check health-related factors. If the product is no longer suitable due to donor-related reasons (e.g., some types of cancer, which were not known at the time of donation), the product will no longer be listed. Any other relevant information about the donor will also be shared with the transplant center, i.e. if a donor is not available for further donations.

If more detailed information about the product is required, it can be found in the ADCU report. The report contains all relevant information of the ADCU, such as test results of infectious disease markers, HLA typing, cell counts such as number of CD34-positive cells, volume, and viability. The ADCU report can be requested via the DKMS Registry at services@dkmsregistry.org. Transplant centers and search units in Germany can contact the DKMS Donor Center Germany, Department Workup: workup@dkms.de.

The safety and well-being of our donors is our utmost priority

For donations to our DKMS Stem Cell Bank, we only ask donors who have already been requested for a peripheral stem cell collection for a specific patient. For the donor, the collection of additional cells does not result in any substantial additional effort, nor any additional health risk, apart from there being a longer apheresis period. The approved duration of the apheresis will not be exceeded. A standard stem cell donation will be carried out in which the permissible blood volume will be processed; it is not necessary to carry out additional administration of G-CSF, nor is an extra day of collection required. The cells collected in this way will be donated for the patient in need of the transplant and the additional cells will be stored in the DKMS Stem Cell Bank.

We fully inform our donors who are eligible to donate an ADCU to the DKMS Stem Cell Bank in advance and ask for additional informed consent.

Donors who have already been selected to donate for a specific patient will be identified according to a certain algorithm, including HLA genotype, age, and weight. Initially, DKMS will consider all donors with particularly frequent HLA genotypes who are requested for workup. In the long term, the HLA profiles of the ADCUs will become more diverse so that as many patients as possible can benefit.

Donor selection criteria:

• Only donors who are donating for a specific patient (PBSC)
• Gender: male and female; preferred male
• Age: men below 40 years of age; women below 30 years of age
• Weight: men above 154 lbs (70 kg) and women above 132 lbs (60 kg)
• Requested cell number and weight of the recipient in relation to the weight of the donor
• HLA type: frequency 1–20,000 of the DKMS Germany donor pool, 5-loci
• Exclusion criteria for donors: according to effective guidelines of the German Medical Association following the German Drug Law

Cord blood units

On top of that, the DKMS Stem Cell Bank operates as a cord blood bank. Cord blood is available as an alternative source for the transplantation of hematopoietic stem cells and shows increasing overall survival rates over the last ten years, comparable to haploidentical related donation and at a better rate than unrelated donors with HLA mismatch. The stem cells from cord blood are collected in a simple and safe way for the mother and the child. In particular, patients with rare HLA characteristics and members of ethnic minorities benefit from the fact that the transplantation of stem cells from cord blood requires fewer matching HLA characteristics. Therefore, cord blood units represent a useful supplement to the treatment of people with diseases of the hematopoietic system.

We are currently cooperating with 12 clinics to collect the stem cells from cord blood and have stored more than 9,500 cord blood units in our DKMS Stem Cell Bank. So far, 126 patients from 22 countries have received a second chance at life with cord blood units from our DKMS Stem Cell Bank.

How to request cord blood units: The process of requesting cord blood units remains unchanged (via the WMDA Search & Match Service and the ZKRD).

Our history

The DKMS Stem Cell Bank (formerly DKMS Cord Blood Bank) was initially founded in 1997 as a third-party funded project in cooperation with the University Hospital Carl Gustav Carus in Dresden, Germany. Since 2008, the non-profit organization has been an independent member of the DKMS family.

Based on our longstanding experience as a cord blood bank, we expanded our activities in 2023 to include the processing, storage, and delivery of ADCUs derived from peripheral stem cell collection for a specific patient.

Authorizations and Accreditations

DKMS Stem Cell Bank gGmbH holds a manufacturing authorization according to the German Drug Law (AMG) §13 and is subject to regular official Good Manufacturing Practice (GMP) inspections. The manufacturing authorization (MIA number: DE_SN_01_MIA_2022_0034) and the GMP certificate in the current version are available in the European Medicines Agency database of good manufacturing practice and good distribution practice (EudraGMDP) (-> OMS Organization Identifier: ORG-100022339).

In addition, the DKMS Stem Cell Bank has been accredited according to the international standards of NetCord-FACT since December 15, 2011. The accreditation covers the collection, processing, storage, and distribution of cord blood from related and unrelated donors.

Our team

Our highly qualified team consists of physicians, biologists, pharmacists, quality unit supervisors, project managers and laboratory staff who have many years of experience in the collection, processing, quality control, storage, release and shipping of stem cells from cord blood. We are aware of the importance of our activities in terms of Good Manufacturing Practice (GMP), German Drug Law (AMG), German Ordinance on the Manufacture of Medicinal Products & Active Substances (AMWHV) and the NetCord-FACT standards in order to be able to guarantee the highest possible safety and efficacy for patients, products, and personnel.