Mesenchymal Stromal Cells in Living Donor Kidney Transplantation

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Renal Transplantation, Mesenchymal Stem Cells

In brief

Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it functioning for a long time. Transplant recipients receive induction therapy and immunosuppression (anti-rejection) drugs to prevent their body from rejecting the new kidney. These drugs are used to prevent the immune system from attacking the transplanted kidney. This research study will evaluate the safety and activity of mesenchymal stromal stem cells (MSCs) infusion compared to saline-only infusion in reducing the immune suppression necessary to achieve optimal renal function in renal transplant recipients. All participants will receive routine care: basiliximab, tacrolimus, mycophenolate mofetil, and corticosteroids.

Key facts

Study ID: NCT03478215
Run by: The Methodist Hospital Research Institute
People needed: 24
Starts: 2016-12-01
Expected to finish: 2026-12-01
Last updated by the study team: 2025-03-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Males and females from 18 to 65 years of age
Planned to receive a primary kidney transplant from a living donor
Low immunologic risk defined as
No history of current or historical antidonor human leukocyte antigen (HLA) antibodies (DSA)
Panel of Reactive Antibodies (PRA) <20%, historical
Low risk for thrombotic events and normal prothrombin time, international normalized ratio (INR) and partial thromboplastin time
Women of child bearing potential have a negative serum pregnancy test prior to transplantation
Women of child bearing potential (including perimenopausal women who have had a menstrual period within the previous 1 year) who agree to use 2 forms of effective birth control regimen (at least one of which is a barrier method) throughout the study period and for 6 weeks following the end of the study or the last dose of mycophenolate mofetil, whichever comes first.
In the opinion of the investigator, the subject is capable of understanding and complying with the protocol.
Subjects must have signed the informed consent document prior to performance of any study related procedure including screening procedure.

You may not qualify if…

Recipient of multiple organ transplantation or scheduled for multiple organ transplantation
Recipient with a donor-specific anti-HLA antibody or positive cross-match requiring deviation from standard immunosuppressive therapy
Hepatitis C antibody positive, Hepatitis B antigen positive, or Hepatitis B core antibody positive
Currently participating in or has participated in an investigational drug or medical device study within 30 days or five half-lives, whichever is longer, prior to enrollment into this study
Concurrent sepsis or active bacterial infection
In the opinion of the investigator is anatomically a high-risk renal transplant with higher chance for thrombosis or bleeding
Have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been treated
Women of child bearing potential who are breastfeeding
History of HIV infection
Subject is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
Subject is not deemed medically stable for the study in the opinion of the Investigator or the subject's nephrologist.

Where it is running

Houston Methodist Hospital System — Houston, Texas, United States

Full record on ClinicalTrials.gov

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