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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Immune Tolerance

Intervention / Treatment
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* Drug: MDR product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational, long-term safety follow-up of patients who have received MDR product<br>Only patients who have received treatment with MDR product will be eligible for this study. | Drug: MDR product<br>* Observation of patients previously receiving MDR product(s)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-term follow-up