Clinical trial
Extension Study to Assess the Long-Term Safety in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products
Name
MDR-105-SAE
Description
At the completion of primary follow-up of various Medeor Transplant studies (called parent studies), subjects receiving Medeor's cellular immunotherapy products will be followed annually for up to an additional 84 months (7 years), in order to evaluate for long-term safety.
Trial arms
Trial start
2022-05-11
Estimated PCD
2031-12-01
Trial end
2031-12-01
Status
Recruiting
Treatment
MDR product
Observation of patients previously receiving MDR product(s)
Arms:
Observational, long-term safety follow-up of patients who have received MDR product
Size
50
Primary endpoint
Safety Endpoints
Through study completion, up to 7 years
Eligibility criteria
Inclusion Criteria:
1. Able and willing to fully comply with all study procedures and restrictions.
2. Able to understand and provide written, signed, and dated informed consent to participate in the study in accordance with ICH GCP Guideline and all applicable local regulations.
3. Have previously completed a Medeor study and received a Medeor cellular immunotherapy product
Exclusion Criteria:
1. Has any condition or circumstance, which in the opinion of the Investigator would significantly interfere with the subject's protocol compliance or put the subject at increased risk.
2. Unable or unwilling to provide written, signed, and dated informed consent to participate in the study.
3. Has undergone a second organ transplant with an organ derived from an individual other than the donor of the transplant kidney received during a Medeor study.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-10-19
1 organization
1 product
1 indication
Product
MDRIndication
Immune ToleranceOrganization
Medeor Therapeutics