Long-term Safety Follow-up in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-008309
NCT ID: NCT05010174
About this study
The purpose of this study is to evaluate the long-term safety in patients previously treated with Medeor cellular immunotherapy products in a Medeor parent study.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Eligibility last updated 8/8/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mark Stegall, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available