Registries - a vital role in cellular therapy
Registries, non-profit organisations, are pivotal in the entire lifecycle of cellular therapy—from recruitment to collection, testing, and distribution of cells. Serving as a crucial link between donation and transplant, registries can function as donor registries, providing cell products from their donors/cord blood banks to global transplant centers. They can also act as patient registries, collaborating with local transplant centers to streamline the search process. Often, registries seamlessly operate in both capacities.
As an association of registries, WMDA is committed to ensuring the safety of both recipients and donors. Therefore, WMDA is operating a robust certification program adhering to the highest international standards and ethical principles. WMDA ensures the utmost respect for the donor’s gift. At the moment, over 80% of the donations are handled by WMDA certified organisations. The certification program encompasses:
- Protection of Personal Data: Ensuring the donor’s identity remains confidential, preventing unauthorized disclosure to the patient or their family.
- Accurate Education: Providing donors with comprehensive information, allowing them to inquire about the donation process.
- Donor Rights: Enabling voluntary donation for any patient in need, with the freedom for donors to change their minds without embarrassment or discomfort.
- Authorized Use: Safeguarding against blood stem cell trafficking, transplant tourism, and commercialism, ensuring cells are only provided to authorized transplant centers overseen by health authorities.
- Informed Consent: Mandating each donor to sign informed consent, with unemancipated minors and legally incompetent adults prohibited from serving as donors.
Patient Registry Process
The call
Upon receiving a call from a transplant center, the patient registry initiates the exploration of transplant options. This involves family searches, unrelated donor searches, and cord blood searches.
The options
Transplant physicians receive a list of potential options, including family donors, unrelated donors, or cord blood. If no fully matched donor is available, alternatives for the most suitable donor are considered, prepared by consulting WMDA’s Search & Match Service.
The selection
Transplant physicians select options for extended or verification typing. Depending on local policy, one to four donors are approached to donate a blood sample for further testing. The patient registry requests the donor registry to contact the potential donor.
The workup
Donors undergo preparation for cell collection, with a scheduled collection date. Donor registries ensure a risk-free process for both voluntary donors and recipients, evaluating medical and social history in accordance with international laws and regulations.
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 oversee the collection process in dedicated centers. A medical director reviews all donor records and makes the final eligibility determination.
The transport
The collected product, labeled with a unique identification number, is shipped for transplant directly to the transplant center by a courier, ensuring traceability from donor to recipient.
The follow-up
The donor registry maintains contact with donors to monitor recovery post-donation. Correspondence and support for donor/recipient families are crucial, with donor and recipients’ identities kept confidential.
Donor Registry Process
The consent
Volunteers sign up globally through dedicated registration websites or events. The critical step is obtaining donor consent, along with completing a medical-social history. This information is used by the donor registry to determine eligibility, following general medical suitability criteria from WMDA.
Waiting till the call
HLA tissue typing is conducted after sign-up, and results are uploaded to the global database, enabling worldwide searches by transplant centers for potential donors.
The call – check-in on the donor
Patient registries notify a donor registry when a potential volunteer is identified. Relevant medical records are reviewed, creating a comprehensive donor profile. Close attention is paid to health updates and any necessary medications.
Preparing for donation
Physical inspections screen for infectious diseases or risky behaviors. If medically eligible , the donor is prepared for cell collection, always treated with dignity and respect.
The collection
Cells are collected on the determined transplantation date, ensuring a respectful process for the donor.
The transport
The collected product is labeled for traceability and shipped directly to the transplant center by a courier.
The follow-up
Donor registries maintain contact to monitor recovery, offering support to donor families and recipients. While recipient identities remain confidential, donors can request updates on the progress of those they’ve supported through transplantation.