MSCs Infusion for Kidney Transplant

Overseen By Linda W Moore, MS,RDN,LD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The Methodist Hospital Research Institute

Must be taking: Immunosuppressants

Disqualifiers: Multiple organ transplant, Hepatitis, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 4 days

24 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

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. ^{1 2 6 7 9}

Who Is on the Research Team?

Ahmed O Gaber, MD

Principal Investigator

Houston Methodist Physicians Organization

Are You a Good Fit for This Trial?

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

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)

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Mesenchymal Stromal Stem Cells (MSCs) Infusion
• Normal Saline (Placebo) Infusion

Trial Overview 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.

How Is the Trial Designed?

Group I: Mesenchymal Stromal Stem Cells Infusion Experimental Treatment 1 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 Infusion Placebo Group 1 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cells infusion prevents acute cellular rejection in rat kidney transplantation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Mesenchymal Stem Cell-Based Therapy for Kidney Disease: A Review of Clinical Evidence. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Mesenchymal stromal cells in kidney transplantation. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Distribution of infused umbilical cord mesenchymal stem cells in a rat model of renal interstitial fibrosis. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Mesenchymal stromal cells in renal transplantation: opportunities and challenges. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical Translation of Mesenchymal Stromal Cell Therapies in Nephrology. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Infusion of mesenchymal stromal cells after deceased liver transplantation: A phase I-II, open-label, clinical study. [2018]

8. England pubmed.ncbi.nlm.nih.gov

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]

9. England pubmed.ncbi.nlm.nih.gov

Induction therapy with mesenchymal stromal cells in kidney transplantation: a meta-analysis. [2021]