Long-term Safety Follow-up in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products

Terminated

• Conditions: Immune Tolerance
• Interventions: Drug: MDR product

• Registration Number: NCT05010174
• Lead Sponsor: Medeor Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Study MDR-105-SAE is intended to be the long-term safety monitoring extension of Medeor's cellular immunotherapy, kidney transplant clinical studies. This Master Protocol has been created in order to establish a single database for all long-term safety data for those subjects that have received Medeor's cellular products. This Master Protocol will provide up to 84 months (7 years) of additional follow-up.

Long-term safety of subjects treated with Medeor's cellular immunotherapy has not been assessed. This study will collect the data into a centralized database allowing for continuous monitoring of any important safety signals.

Study Timeline

• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-18
• Study Start: 2022-05-11
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational, long-term safety follow-up of patients who have received MDR product	MDR product	Only patients who have received treatment with MDR product will be eligible for this study.

Primary Outcome Measures

Name	Time	Method
Safety Endpoints	Through study completion, up to 7 years	Incidence of serious adverse events (SAEs), adverse events (AEs) leading to study withdrawal, and hospitalizations.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States