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

Extension Study to Assess the Long-Term Safety in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products

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.

Study Overview

• Status: Recruiting
• Conditions: Immune Tolerance
• Intervention / Treatment: Drug: MDR product

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Lenuta Micsa, MD; Phone Number: 646-239-9748; Email: lmicsa@medeortx.com

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale University
      • Contact: Ricarda Tomlin; Phone Number: 203-785-2073; Email: ricarda.tomlin@yale.edu
      • Contact: William Asch, MD; Phone Number: 203-785-4184; Email: william.asch@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Observation of patients previously receiving MDR product(s)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medeor Therapeutics, Inc.
• Investigators: Study Director: Lenuta Micsa, MD, Medeor Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Long-term follow-up
• Other Study ID Numbers: MDR-105-SAE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No