NCT05010174

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Medeor Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Immune Tolerance

Interventions

Type	Name	Description
DRUG	MDR product	Observation of patients previously receiving MDR product(s)

Timeline

• Start date: 2022-05-11
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2021-08-18
• Last updated: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study