For Transplant Centers and Stem Cell Registries
The Finnish Red Cross Blood Service maintains the Finnish Stem Cell Registry that has over 65 000 volunteer donors that have agreed to donate blood stem cells for patients in need of transplantation. The Registry is actively recruiting new donors. In addition, the Finnish Cord Blood Bank has over 3 000 cord blood units that can be used as alternative stem cell grafts.
Who can access our services?
The Stem Cell Registry carries out searches of both adult donors and cord blood units in the Finnish and in internationals stem cell registries. The Registry will carry out search requests for international registries that are members of the WMDA, and for its associated transplant centres (the Finnish and the Tartu transplant centres). The transplantation centres for whom donor searches are performed must be authorized by a supervisory authority to carry out haematologic stem cell transplants. If necessary, the Registry can require that the transplant centre provide a report on its operations before the registry can approve its searches for patients. The Stem Cell Registry has a valid operating permit as a tissue establishment granted by the Finnish Medicines Agency Fimea and a Qualification status granted by WMDA.
The WMDA member registries, whose patients are approved for donor searches, are listed on the WMDA web pages.
Informing the donor and the patient
Donors give informed voluntary consent upon joining the registry, and again at the verification typing stage and before donation. The donor can withdraw their consent at any stage of the process without stating a reason.
The transplant centre is responsible for informing the patient of the donor’s right to withdraw at any stage of the process and that the donor is not obliged to donate a second time.
Data and Matching requirements
The Stem Cell Registry only approves those patients for a search who have a diagnosis that is a commonly accepted indication for a stem cell transplantation. (RF Duarte et al: Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplantation 2019). In addition to these indications, the registry approves the AGU and INCL diagnoses that are a part of the Finnish disease heritage. The transplant centre can also request a search for patients whose diagnoses are not approved on the list of indications. In this case, the transplant centre must provide a written document that describes the reasons why the patient would benefit from transplantation, or that the transplantation is performed as part of a clinical trial that has been approved by the institutional review board. This description is reviewed by a Registry physician, who may request an opinion from the medical ad¬visory group of the Registry.
HLA-typing and Matching
The basic requirement for patient tissue typing is that the HLA- A, -B, -C and DRB1 loci have been typed at high resolution. Domestic patients shall be HLA typed according to the nationally agreed protocol from at least two samples taken on different dates, and the results of the two samples must be consistent.
If HLA matching status between the patient and the donor is less than 8/10, a written rationale from the transplant center is required. This rationale is reviewed by a registry physician, who may request an opinion from the medical ad¬visory group.
Before starting a search, the transplant centre shall assess the patient’s overall situation (diagnosis, ur¬gency of the search process, prevalence of the tissue type) and create a search strategy based on this information. The search strategy and donor selection shall take into account at least the following:
- HLA compatibility of the donor and patient
- whether adult donors or cord blood products are being searched for the transplant
- age, CMV status
- ABO and Rh blood groups
- ethnic background
- height and weight
The transplant centre shall provide this information to the Registry before the search. In select situations, the search may be initiated before all this information has been made available.
At the starting phase of a search, the transplant centre determines the optimal schedule for a stem cell transplantation. The urgency class may be ‘standard’, ‘urgent’ or ‘very urgent’. In standard searches, the search is performed during the same or the following working day. In urgent and very urgent cases, the donor search is performed immediately upon receiving the request, during working hours of the Registry.
The standard donor search schedule is for a donation that is planned within 3–6 months. In an urgent search, the intention is to perform the stem cell transplantation within 2–3 months. In a very urgent donor search, the donation is needed in less than 2 months. If a very urgent search is requested for a patient, the transplant centre shall submit a short justification.
At the transplant centre’s request, a permanent search may be set for patients for whom an eligible donor candidate cannot be found. In a permanent search, the Stem Cell Registry creates a new donor search for a patient monthly. The permanent search is available only for the domestic and the Tartu transplant centres, and the transplant centre shall request it in writing. The clinical status of a patient in permanent search shall be updated once a year. If the patient is no longer eligible for transplantation, they are deleted from the permanent search.
When a donor candidate is selected as a donor, the donor will be considered reserved for the particular patient until the collection has taken place or the donor has been released in writing by the TC. The maximum period for the reservation is two months. If the TC wishes to extend the reservation for another two months, they must apply for the extension and describe the reasons for this in writing.
A search may only be cancelled by a transplant centre physician who is treating the patient. A written notice of search cancellation must be submitted to the Stem Cell Registry.
The cancellation notice must include at least the following:
- Patient’s name and ID
- Treating physician’s name and signature
- Reason for the cancellation
- Stem Cell Registry coordinators will release all reserved donors when a cancellation notice has been received.
The donor candidate is informed that they are requested to donate again. The donor does not have to commit to a new donation. The donor must have enough time to consider their consent. The request for a second donation must not place pressure on the donor.
After donation, the donor is kept on standby (status TU) for the recipient patient for 24 months. If the patient dies, the donor can be released after 4 weeks of the donation (status AV). As a general rule, the second collection should take place no sooner than four (4) weeks after the first donation. A collection taking place earlier can be approved in exceptional cases (for example, if the graft is destroyed before the transplantation has been performed), pending evaluation by the Stem Cell Registry and careful discussion with the donor.
A third donation may be approved in exceptional cases when the matter has been discussed thoroughly with the donor, with an emphasis on the voluntariness of the donation. Second or third grafts may be collected from bone marrow or peripheral blood.
Donors may be asked to provide a separate consent for using their samples in scientific research. All research studies must adhere to international guidelines regarding research on human subjects The project must have undergone appropriate ethical review and must be approved by the Finnish Stem Cell Registry.
The donor has the right to decline participation in a scientific research project at any time. They do not need to state reasons for declining, and refusal shall not affect the donation of stem cells in any way.