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

NCT05010174 | Terminated DMC FDA Drug

• 1 other identifier: MDR-105-SAE
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Tolerance

Keywords

Long-term follow-up

Outcome Measures

Primary Outcomes (1)

• Safety Endpoints

  Incidence of serious adverse events (SAEs), adverse events (AEs) leading to study withdrawal, and hospitalizations.

  Through study completion, up to 7 years

Study Arms (1)

Observational, long-term safety follow-up of patients who have received MDR product

Only patients who have received treatment with MDR product will be eligible for this study.

Drug: MDR product

Interventions

MDR product DRUG

Observation of patients previously receiving MDR product(s)

Observational, long-term safety follow-up of patients who have received MDR product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients who received Medeor's cellular immunotherapy in previous Medeor studies

You may qualify if:

• Able and willing to fully comply with all study procedures and restrictions.
• 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.
• Have previously completed a Medeor study and received a Medeor cellular immunotherapy product

You may not qualify if:

• 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.
• Unable or unwilling to provide written, signed, and dated informed consent to participate in the study.
• 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.

Sponsors & Collaborators

• Medeor Therapeutics, Inc.: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

Study Officials

• Lenuta Micsa, MD

  Medeor Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 18, 2021
• Study Start: May 11, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

US (1)