Immune Tolerance
Conditions
Keywords
Long-term follow-up
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.
Interventions
DRUGMDR product
Observation of patients previously receiving MDR product(s)
Sponsors
Medeor Therapeutics, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoints | Through study completion, up to 7 years | Incidence of serious adverse events (SAEs), adverse events (AEs) leading to study withdrawal, and hospitalizations. |
Countries
United States
Outcome results
None listed