MSCs Infusion for Kidney Transplant

Recruiting in Palo Alto (17 mi)

Overseen byAhmed O Gaber, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: The Methodist Hospital Research Institute

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing whether infusing special cells called mesenchymal stromal stem cells (MSCs) can help kidney transplant patients need fewer strong anti-rejection drugs. The study focuses on people who received a kidney from a living donor. MSCs might help control the immune system to protect the new kidney better. Mesenchymal stem cells (MSCs) have been studied for their potential to improve kidney transplant outcomes through their immunomodulatory, reparative, and regenerative properties.

Eligibility Criteria

This trial is for adults aged 18-65 planning to receive their first kidney transplant from a living donor, with low immune risk and no history of certain antibodies or high risk for blood clots. Women must not be pregnant, agree to use two forms of birth control, and cannot breastfeed. Participants should not have HIV, active infections or cancer (except treated skin cancer), and must not have been in another study recently.

Inclusion Criteria

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

+7 more

Exclusion Criteria

History of HIV infection

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

+8 more

Participant Groups

The trial is testing the safety and effectiveness of mesenchymal stromal stem cells (MSCs) infusion versus saline (a placebo) in reducing the need for anti-rejection drugs after a kidney transplant. All participants will also get standard care including basiliximab, tacrolimus, mycophenolate mofetil, and corticosteroids.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mesenchymal Stromal Stem Cells InfusionExperimental Treatment1 Intervention

Intervention: Mesenchymal stromal stem cells infusion. This is the active investigational intervention, administered intravenously at surgery and day 4 post-transplant in a dose-escalation fashion beginning as 1x10\^6 cells for the first dose group, 2x10\^6 cells for the second dose group, or 3x10\^6 cells for the last dose group. The infusion set-up will be covered to mask the group assignment. Participants will also receive BASILIXIMAB (Simulect, for all subjects at a standard dose, 20mg reconstituted with normal saline or 5% dextrose) on the day of surgery and day 3 or 4 post-transplant administered by a member of the anesthesia team; TACROLIMUS (Prograf for maintenance therapy), MYCOPHENOLATE MOFETIL (Cellcept for maintenance therapy), and CORTICOSTEROIDS as routine care.

Group II: Placebo InfusionPlacebo Group1 Intervention

Placebo: A normal saline infusion. This is the placebo intervention to occur at surgery and day 4 post-transplant. The infusion set-up will be covered to mask the group assignment. Participants will also receive BASILIXIMAB (Simulect, for all subjects at a standard dose, 20mg reconstituted with normal saline or 5% dextrose) on the day of surgery and day 3 or 4 post-transplant administered by a member of the anesthesia team; TACROLIMUS (Prograf for maintenance therapy), MYCOPHENOLATE MOFETIL (Cellcept for maintenance therapy), and CORTICOSTEROIDS as routine care.