What is a registry?
A registry is a non-profit organisation that plays a critical role in the recruitment, donation, collection, testing, and distribution of cells for use in cellular therapy. As a bridge between donation and transplant, registries can serve either as donor registries, providing cell products from their donors/cord blood banks to national and international transplant centers, or patient registries, partnering with local transplant centers to assist them with the search process. In most cases, registries serve in both roles.
As a membership organisation of registries, WMDA is dedicated to ensuring the safety of both the recipient and the donor. To achieve this, WMDA operates a comprehensive certification program that adheres to the highest international standards and ethical principles for respecting the donor’s gift. The certification programme covers:
- Protection of personal data: no unauthorised disclosure of the donor’s identity to the patient or the patient’s family.
- Accurate education: donors receive complete information and have the opportunity to ask questions about the donation process.
- Donor rights: donors donate voluntarily for any patient in need of a transplant and are informed that they can change their mind at any time, without any undue embarrassment or discomfort.
- Authorised use: WMDA strives to protect donors against blood stem cell trafficking, transplant tourism and commercialism, including incentives. Blood stem cells are only provided to authorised transplant centres overseen by health authorities.
- Informed consent: each donor must sign an informed consent; unemancipated minors and legally incompetent adults may not serve as donors.
The Phases of the process - from the patient registry side
The call
A patient registry receives a call from a transplant centre that a patient is need of a transplant. The options for transplant needs to be explored by doing a family search and/or an unrelated donor search and/or a cord blood search.
The options
The transplant physicians receives a list with potential options for their patients. This can be a family donor, an unrelated donor or cord blood. In case there is no fully matched donor, options for the most suitable donor. The list of potential options is prepared by the patient registry by consulting WMDA’s Search & Match Service.
The selection
The transplant physician selects options to be explored for extended or verification typing. Depending on the local policy, one till four donors are approached and to ask to donate a blood sample for further testing. The patient registry requests the donor registry to contact the donor. The donor registry seeks contact with the potential donor. In some cases, it can be years ago that a donor signed up. The donor registry checks the willingness to donate and the medical-social history is updated. Also a blood sample is collected to perform additional testing.
The workup
The donor is prepared for the procedure to collect cells and the collection date is scheduled. After consent is given, the donor registry pays close attention to the individual donating cells to make sure that there is no risk for both the voluntary donor and the recipient. The evaluation of the donor’s medical and social history is conducted in accordance with international laws and regulations. The WMDA has developed Donor Medical Suitability Recommendations, which are reviewed regularly, and are publicly available.
To ensure the safety of the recipient, only donations that have met strict evaluation guidelines are distributed. Our commitment to safety and quality is unwavering, and our member registries strive to fulfill the minimum legal requirements for quality and safety set by the international regulatory bodies.
The collection
Specially trained healthcare professionals evaluate the donor and collection process in dedicated collection centres. A medical director reviews all records for the donor and makes the final eligibility determination.
The transport
After collection, the product is labelled with a unique identification number to allow traceability from donor to recipient. It is then shipped for transplant by a courier directly to the transplant centre.
The follow-up
The donor registry is keeping contact with the donor to check is the recovery after the donation. Correspondence with, and support of, donor families and recipients is important. Although the identity of recipients cannot be revealed, a donor can request to know how the recipient that has been helped through transplantation and how is progressing.
The Phases of the process - from the donor registry side
The consent
Registries worldwide recruit volunteers in different ways to sign up and to join our global community of 40 million volunteers dedicated to help any patient in the world. Donor can sign up online on dedicated registration websites or during special events. Important part of signing up is the donor consent. If consent is given, the dojnor is asked to complete a medical-social history. The medical-social history provides the donor registry with information to make a donor eligibility determination. WMDA has general donor medical suitability criteria publicly available, which is used by many WMDA members.
Waiting till the call
After the volunteer has signed up as a potential donor, a test will be done called HLA tissue typing. The immune system uses HLA proteins found in the surface of cells to identify which cells belong to your own body and which do not. The HLA typing of the volunteer donor is uploaded in the global database, so that the donor can be searched for by transplant centres worldwide.
The call – check-in on the donor
A patient registry contacts the donor registry when a potential volunteer has been identified by the transplant centre. The donor registry obtains an update of the relevant medical records for review, a step in the process of creating a complete donor profile. Donor registry pays close attention to the health of the volunteer donor and any medications that are administered. In some cases it might be years ago that the donor has signed up and the situation may have changed. It may be that more than one donor is contacted at this stage.
Preparing for donation
If there are no medical “contraindications” the designated medical staff performs a physical inspection of the donor and the transplant centre has indicated to continue with the collection. This physical inspection contributes to the donor profile, and screens for physical signs of infectious disease or behaviour that may have put them at risk, such as intravenous drug use. A blood sample is drawn from the donor to be tested for HIV I and II, Hepatitis B and C, and Syphilis.
The collection
When the transplantation date has been determined, the donor is prepared for the procedure to collect the cells. During the collectiom, the donor is always treated with dignity and respect.
The transport
After collection, the product is labelled with a unique identification number to allow traceability from donor to recipient. It is then shipped for transplant by a courier directly to the transplant centre.
The follow-up
The donor registry is keeping contact with the donor to check is the recovery after the donation. Correspondence with, and support of, donor families and recipients is important. Although the identity of recipients cannot be revealed, a donor can request to know how the recipient that has been helped through transplantation and how is progressing.