ADCU stands for Adult Donor Cryopreserved Unit. 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 can be processed into ADCUs; these are stored in our stem cell bank and can be made available to the next patient in need - the donor can save two lives with just one donation. The name ‘ADCU’ has been globally aligned by the WMDA.

ADCUs are derived from peripheral hematopoietic stem cells from unrelated volunteer adult donors already in the collection process for a specific patient (directed donation). ADCUs can be collected if donors mobilize more stem cells than the patient needs. The additionally obtained cells are processed into an undirected ADCU, stored in our DKMS Stem Cell Bank, and can be made available to any patient in need. The product will only be split if the prioritized directed product has CD34-positive cells as requested plus margin and also the ADCU is within specifications. If collection results do not meet ADCU specifications, the entire product is sent to the transplant center (not necessarily larger volume).

ADCUs are currently available for search and request via the DKMS Registry. Please use the request form “Formal Request for Adult Donor Cryopreserved Unit Shipment”, which is available for download here.

Transplant centers and search units in Germany should directly contact the DKMS Donor Center Germany, Department Workup: workup@dkms.de. ADCUs will be available via the WMDA Search & Match Service by the end of 2024.

Our search and request process is the following:

If you receive the information that an ADCU is included in the search results for your patient, you can send an email to services@dkmsregistry.org and we can provide you with the appropriate product data sheet.

The donor’s availability and the duration from request to transplantation are crucial aspects of unrelated hematopoietic stem cell transplantations. Our DKMS Stem Cell Bank provides cryopreserved stem cell products effectively and efficiently to address this and make life-saving stem cells available faster.

For the patient, this means a significantly shorter time to transplantation: With the donation already completed, our ADCUs are immediately available and ready to use. There is no need to activate the donor, as the process of the preliminary examination and donor clearance will already have taken place. These time efficiencies enable much better planning for the conditioning of the patient. Additionally, 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 delivery. Listed ADCUs have a 100% availability, since they are immediately accessible and ready to use for transplantation.

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 stem cells are minimally manipulated during the manufacturing process by centrifugation and filling. The final concentration of dimethyl sulfoxide (DMSO) is 5%.

Yes, once the ADCU is approved, listed, and available for patients, the transplant center will be notified by DKMS.

Our goal is to cryopreserve ADCUs with common HLA phenotypes to ensure that the products help patients in need and are not be stored for long periods and are unlikely to match a patient. There is an algorithm to only approach donors who are expected to have excessive mobilization (e.g. due to weight or sex) and excessive cells (donor-patient weight ratio). In addition, ADCUs can only be obtained and manufactured at certain collection centers (with regulatory approval) and will not apply to the majority of collections. Transplant centers do not need to be involved in the decision as there is no change in Workup request and procurement of the directed product.

For patients, we do not see any need to modify the consent, as in the bag still contains mobilized peripheral stem cells from adult unrelated donors, with the only difference that the DKMS Stem Cell Bank has cryopreserved them and not the (partner) laboratory of the transplant center.

Collection is subject to national guidelines and approval by regional and federal authorities. Mandatory limits are set for the duration of the collection, donor blood volume processed, product volume collected, and platelet levels.

In addition, Collection Center physicians will closely monitor the donor's well-being and may at any time decide not to prolong the collection. Priority is always the product for the patient and the donor´s safety. Donors will never receive additional doses of G-CSF. Nor are they asked for a second day of apheresis just to get an ADCU.

The price is the same as for the PBSC according to the price list.

The process for requesting a directed product remains unchanged, and collection centers will continue to prioritize fulfilling these requests. They aim to collect the requested cell dose plus at least 20%, which is beneficial for transplant centers (TCs) as it ensures they receive more cells than requested. TCs are advised to cryopreserve any surplus cells for future use. It's important to note that donors have only consented to the cryopreservation of leftover cells, not full second donations.

There's no intention to collect an extra dose beyond what's requested, though sometimes an excess of cells occurs due to procedural reasons. TCs cannot claim these excess portions, and there's no donor consent for collecting more cells than requested.

ADCUs will presumably be listed in the WMDA Search & Match results by the end of 2024. However, you can already send a preliminary search request to the DKMS Registry now. ADCUs will be included in the matching list provided by the DKMS Registry.

Unfortunately, ADCUs cannot be transmitted via EMDIS and will not be included in EMDIS search results. However, the DKMS Registry will send an automatic message (via EMDIS) whenever a matching ADCU is available for a patient sent via EMDIS. After receiving this message, further information can be requested from the DKMS Registry via services@dkmsregistry.org.

Yes, the ADCUs appear in the search lists in the same way as the donors, i.e. further information on ADCUs is displayed directly. Transplant centers and search centers in Germany can request further information directly from the DKMS Donor Center, Workup Department: workup@dkms.de. The ADCU report as well as the formal request form will be provided.

No, it is not reserved automatically. Once the ADCU is released and listed as a non-directional product (which can take 2 weeks or more), it is available to all patients. However, the transplant center can reserve the ADCU (3 months) upon request with justification (e.g. engraftment failure).

ADCUs can be requested via the DKMS Registry at services@dkmsregistry.org. Please use the request form “Formal Request for Adult Donor Cryopreserved Unit Shipment”, which is available for download here.

Transplant centers and search units in Germany should directly contact the DKMS Donor Center Germany, Department Workup: workup@dkms.de.

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, such as certain 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 no longer available for further donations.

When a transplant center requests an ADCU, the product is reserved for two weeks. Once a patient has received an ADCU, the respective donor will be reserved for two years if they are not still reserved for another patient or blocked for other reasons. Please note: An ADCU is not automatically reserved for the patient of the directed donation.

Once a patient has received an ADCU, the respective donor will be reserved for two years if not still reserved for another patient or blocked for other reasons.

In general, it is possible to request samples for various testing (including DNA, serum, and plasma).

However, the number of retained samples for each unit is limited. Therefore, we would ask you to note the following:

• Verification typing (VT) of the donor has been performed prior to the stem cell collection.
• The identity of the unit will be re-verified (HLA A, -B, -DRB1 typing) at the time of a work-up request.
• All test results of the ADCU incl. infectious disease markers (IDM) are displayed on the unit report.
• When the ADCU is shipped, samples will be provided for VT in your laboratory or for further testing.

In case a 2nd donation is required, the process is unchanged. A transplant center (TC) can request a “fresh” 2nd donation and does not have to request the ADCU, as there may be reasons why they prefer a fresh donation or the specification would not fit the specific patient. Our staff will inform the TC of the availability of an ADCU.

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. However, the results of the internal quality control will be provided after 14 days.

ADCUs are shipped in a validated cryoshipper including monitoring of shipping duration, temperature, and tilt and shock event. The transport is carried out without delay by the authorized courier. The transport temperature is ≤-170°C upon delivery of the cryoshipper. The DKMS Stem Cell Bank usually organizes the transport to the transplant center; if desired, the transplant center can also organize the transport itself.

An unrelated donor is reserved for 2 years after the donation for a specific patient. According to the German standards a donor can generally donate both via peripheral stem cells and bone marrow twice, respectively - if the donor is a fit candidate for both donation types. It is transparent to each transplant center how often a donor has donated and thus will be able to consider this when requesting an ADCU. The scenario is comparable with multi-donations (a donor who donates for two different patients). If a donor with a stored ADCU donates a second time peripheral stem cells there is a good chance that the donor may donate a second ADCU as well.

A donor may always be requested for an MNC apheresis. If the donor is still reserved for the first patient, DKMS will get in touch with the other transplant center.

The procedure is the same as before. The transplant center can request a 2nd donation at any time the patient needs it, but always has the option to request the ADCU if it is still available (of which they will know the specifications and have a 100% and fast availability). If the ADCU was requested for a 2nd patient, the donor would be still available as now.

Both patients/transplant centers may request for donor lymphocyte infusion (DLI) or a second donation. If a donor was able to donate an ADCU in the first collection, it may be also possible in a second collection. The proportion of 2nd donations is significantly lower than the proportion of DLIs and these are not limited. The donor is also informed that this may happen.

The ADCU remains available if the cause of death does not compromise the safety and efficacy of the ADCU. Donors are informed of this very special situation in the consent form.

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.