Donor Follow-Up

Post Donation Follow-Up

Donor follow-up will be initiated after the first injection of a mobilizing agent, the administration of anesthesia, or the beginning of apheresis (in case of MNC Apheresis), independently of completion of the collection. The donor’s health must be assessed to monitor the recovery process, long-term health effects after the donation and the availability for further donations.

  • All DKMS donors have a minimum of 10-year post-donation follow-up.
  • Follow-up questionnaires are sent out to the donor 1 month, 6 months, 1 year, and then annually until 10 years post-donation.
  • For non-US donors a blood test is done 1 month post-donation.
  • If there are abnormal findings, timely controls will be arranged with the donor upon the physician’s / medical advisor’s decision.

Adverse Events and Reactions Reporting (SEAR/SPEAR)

To ensure donor’s and recipient’s health and safety, all adverse events and reactions of unrelated donors or patients have to be reported to WMDA to gain insight in the occurrence of health incidents or risks. This also applies to MNC Apheresis.

SEAR Reporting

  • The DKMS donor center affected by the SEAR submits the report to the registry it is associated with or directly to WMDA and to national authorities accordingly if required.
  • At the end of the year a negative report is sent to WMDA in case there was no adverse event.
  • If there is a risk of disease transmission to the recipient (e.g. infectious disease, malignancy), the transplant center will be informed.
  • Any SEAR is documented in a way that allows tracking and analysis.

SPEAR Reporting

  • Reporting product or patient adverse events / reactions is primarily within the responsibility of the transplant center and the associated patient registry.
  • DKMS Registry has implemented the following procedure to ensure that all adverse events and reactions are reported to WMDA for cases where DKMS Registry is the patient registry.
    • Transplant centers that use the search service of DKMS Registry must agree during the evaluation of their center that serious events will be reported to DKMS Registry within 2 weeks after occurrence.
    • Once per year, DKMS Registry asks all transplant centers that have received stem cell products via DKMS Registry in the previous year to fill a SPEAR questionnaire.
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