Mesenchymal Stromal Cells + Immunosuppressants for Kidney Transplant Recipients
(TEACH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of administering mesenchymal stromal cells (MSCs) to kidney transplant recipients. These special cells may reduce the need for long-term use of anti-rejection drugs (immunosuppressants). The trial aims to determine if adding MSCs allows patients to gradually decrease or stop these drugs, which often cause serious side effects such as infections and cancer. Participants should be undergoing a kidney transplant from a donor who is not a perfect match and must have immunity to certain viruses like Epstein-Barr and Cytomegalovirus. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it aims to help participants reduce or stop anti-rejection drugs. You should discuss your current medications with the trial team to understand any specific requirements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mesenchymal stromal cells (MSCs) have been tested in people before, and these studies indicate that MSCs are generally safe. In one study, patients received MSCs without any serious side effects. Another study found that repeated doses of donor MSCs did not cause any immediate negative effects.
This trial tests MSCs with various anti-rejection drugs. These drugs, such as Alemtuzumab, Belatacept, and Sirolimus, are already used in transplant patients to help prevent organ rejection. Since the FDA has approved these drugs for transplants, their safety is well-known when used correctly.
While the safety of using MSCs with these drugs is still under investigation, existing research suggests that MSCs are safe for humans at the doses previously tested.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using Mesenchymal Stromal Cells (MSCs) for kidney transplant recipients because they offer a unique approach to preventing organ rejection. Unlike standard treatments, which typically involve a combination of immunosuppressants like Tacrolimus, Cyclosporine, and Mycophenolate Mofetil, MSCs work by modulating the immune system in a more targeted way, potentially reducing the side effects associated with long-term use of traditional immunosuppressants. The infusion of MSCs could enhance the body's acceptance of the new kidney while minimizing the risk of infection and other complications. This innovative method could represent a significant advancement in transplant medicine by improving outcomes and quality of life for patients.
What evidence suggests that this trial's treatments could be effective for kidney transplant recipients?
This trial will evaluate the use of mesenchymal stromal cells (MSCs) in kidney transplant patients. Participants will receive MSCs in varying dosages alongside anti-rejection drugs. Studies have shown that MSCs can be safely used in kidney transplant patients, and research suggests these cells might reduce the need for anti-rejection drugs, which can have harmful side effects. In earlier studies, MSCs helped adjust the immune system's response, similar to traditional treatments. Initial findings also suggest that donor MSCs could reduce the amount of strong medications like Tacrolimus needed by transplant patients, potentially leading to fewer side effects and a healthier outcome.23678
Who Is on the Research Team?
Allan D. Kirk, M.D., Ph.D.
Principal Investigator
Duke University Medical Center: Transplantation
Are You a Good Fit for This Trial?
This trial is for adults needing a kidney transplant from a living donor who's not an exact tissue match. They must have immunity to Epstein-Barr and Cytomegalovirus (if the donor has it), meet organ sharing network criteria, and agree to use effective birth control. People with immune deficiencies, certain cancers, high-risk kidney diseases, or recent immunosuppressive drugs can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Participants receive induction therapy with alemtuzumab followed by maintenance therapy with sirolimus and belatacept
MSC Infusion
Participants receive 12 infusions of donor-derived MSCs starting on Day 42 post-transplant and every 4 weeks starting on Day 56 post-transplant
Immunosuppression Withdrawal
Participants are evaluated for eligibility for sirolimus withdrawal between week 52 and week 104 post-transplant
Follow-up
Participants who successfully complete Immunosuppression Withdrawal undergo 24 weeks of high frequency follow up followed by 132 weeks of standard follow up
What Are the Treatments Tested in This Trial?
Interventions
- Alemtuzumab
- Belatacept
- Donor-derived Mesenchymal Stromal Cells
- Mycophenolate Acid
- Mycophenolate Mofetil
- Prednisone
- Sirolimus
Alemtuzumab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
PPD DEVELOPMENT, LP
Industry Sponsor
David Simmons
PPD DEVELOPMENT, LP
Chief Executive Officer since 2012
BSc in Applied Science from Georgia Institute of Technology
Martina Flammer
PPD DEVELOPMENT, LP
Chief Medical Officer since 2024
MD
PPD Development, LP
Industry Sponsor
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University
Immune Tolerance Network (ITN)
Collaborator
Rho Federal Systems Division, Inc.
Industry Sponsor