Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT03321656
Eligibility Criteria:
Inclusion Criteria:
* Fluent in English able to understand and provide informed consent.
* End stage renal disease listed for primary solitary kidney transplant.
* Willing to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent.
* Female who are of childbearing potential will be asked to use 2 different medically acceptable methods of contraception for the duration of the study and at least 1 year post-infusion.
Exclusion Criteria:
* Previously undergone organ, tissue or cell transplant
* Allergic to Tacrolimus or MMF (Cellcept)
* Chronic use of blood thinners
* Previous chronic use of glucocorticoids or other immunosuppression, or biologic immunomodulators (prescribed for the treatment of serious inflammatory disorders)
* Significant or active infection
* Diagnosed with HIV, Hepatitis B or C, Herpes simplex virus, Varicella-Zoster virus, Epstein-Barr virus
* Have or have had cancer with in the past 3 years
* Have taken part in another study that involved an investigational drug within the last 12 months.
* Have a history of delayed or abnormal wound healing
* Are pregnant or breastfeeding
* Had a transfusion within the past 3 months
* Have or plan to be receive a live vaccination (intranasal influenza measles, mumps, rubella, oral polio, yellow fever, varicella)
* Are unable or unwilling to comply with study protocol or procedures.
* Current use anticoagulation medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03321656
Study Brief:
Protocol Section:
NCT03321656