MSCs Infusion for Kidney Transplant
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, all participants will receive specific medications as part of the study, including basiliximab, tacrolimus, mycophenolate mofetil, and corticosteroids.
What data supports the effectiveness of the treatment Mesenchymal Stromal Stem Cells (MSCs) Infusion for kidney transplant?
Is MSC infusion safe for kidney transplant patients?
How does the MSCs infusion treatment for kidney transplant differ from other treatments?
The MSCs infusion treatment for kidney transplant is unique because it uses mesenchymal stem cells, which have the ability to modulate the immune system and promote kidney recovery without the need for traditional immunosuppressive drugs. This approach aims to prevent acute cellular rejection and improve kidney function by directly infusing these cells into the renal artery, offering a novel mechanism compared to standard treatments.12479
Research Team
Ahmed O Gaber, MD
Principal Investigator
Houston Methodist Physicians Organization
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mesenchymal stromal stem cells or placebo infusion at surgery and day 4 post-transplant, along with routine care including basiliximab, tacrolimus, mycophenolate mofetil, and corticosteroids
Safety Evaluation
Safety analyses conducted after each group of 4 subjects completes 30-90 days post-transplant to assess inflammatory response and adverse events
Follow-up
Participants are monitored for safety and effectiveness, including assessment of acute rejection, graft loss, or death
Treatment Details
Interventions
- Mesenchymal Stromal Stem Cells (MSCs) Infusion
- Normal Saline (Placebo) Infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Methodist Hospital Research Institute
Lead Sponsor
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborator