24 Participants Needed

MSCs Infusion for Kidney Transplant

DC
LW
Overseen ByLinda W Moore, MS,RDN,LD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The Methodist Hospital Research Institute
Must be taking: Immunosuppressants
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Research shows that MSCs can help improve kidney function and reduce tissue damage in animal models of kidney transplantation by modulating the immune response. Initial clinical studies suggest that MSC infusion is safe and may help prevent organ rejection in kidney transplant patients.12345

Is MSC infusion safe for kidney transplant patients?

Initial clinical studies suggest that MSC (mesenchymal stromal cell) infusion is safe and well tolerated by kidney transplant recipients. Ongoing research aims to provide more evidence on long-term safety and the best ways to use these cells.45678

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

AO

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

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
See 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
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

4 days
2 visits (in-person)

Safety Evaluation

Safety analyses conducted after each group of 4 subjects completes 30-90 days post-transplant to assess inflammatory response and adverse events

30-90 days

Follow-up

Participants are monitored for safety and effectiveness, including assessment of acute rejection, graft loss, or death

6 months

Treatment Details

Interventions

  • Mesenchymal Stromal Stem Cells (MSCs) Infusion
  • Normal Saline (Placebo) Infusion
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+

Center for Cell and Gene Therapy, Baylor College of Medicine

Collaborator

Trials
114
Recruited
2,900+

Findings from Research

Mesenchymal stromal cells (MSC) have shown promise in kidney transplantation, demonstrating safety and feasibility in initial clinical studies, with potential to reduce the need for immunosuppressive drugs.
Some patients treated with MSC therapy exhibited biomarkers indicating immunomodulation, leading to successful and safe complete discontinuation of immunosuppression in one case, highlighting the potential for personalized treatment approaches.
Mesenchymal stromal cells in kidney transplantation.Casiraghi, F., Remuzzi, G.[2021]
In a phase II clinical trial involving 52 patients with chronic kidney disease (CKD), the infusion of autologous CD34+ cells was found to be safe, with no adverse events reported during the treatment.
The study showed that patients receiving CD34+ cell therapy had significantly lower rates of unfavorable clinical outcomes (like dialysis or death) after one year compared to the control group, indicating potential efficacy in improving long-term outcomes for CKD patients.
Safety and efficacy of intrarenal arterial autologous CD34+ cell transfusion in patients with chronic kidney disease: A randomized, open-label, controlled phase II clinical trial.Yang, CC., Sung, PH., Cheng, BC., et al.[2021]

References

Mesenchymal stem cells infusion prevents acute cellular rejection in rat kidney transplantation. [2022]
Mesenchymal Stem Cell-Based Therapy for Kidney Disease: A Review of Clinical Evidence. [2020]
Mesenchymal stromal cells in kidney transplantation. [2021]
Distribution of infused umbilical cord mesenchymal stem cells in a rat model of renal interstitial fibrosis. [2018]
Mesenchymal stromal cells in renal transplantation: opportunities and challenges. [2018]
Clinical Translation of Mesenchymal Stromal Cell Therapies in Nephrology. [2022]
Infusion of mesenchymal stromal cells after deceased liver transplantation: A phase I-II, open-label, clinical study. [2018]
Safety and efficacy of intrarenal arterial autologous CD34+ cell transfusion in patients with chronic kidney disease: A randomized, open-label, controlled phase II clinical trial. [2021]
Induction therapy with mesenchymal stromal cells in kidney transplantation: a meta-analysis. [2021]