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Immune Tolerance

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

Sponsored by Medeor Therapeutics, Inc.

About this trial

Last updated a year ago

Study ID

MDR-105-SAE

Status

Terminated

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status