Mesenchymal Stromal Cells + Immunosuppressants for Kidney Transplant Recipients
(TEACH Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent rejection of the new organ. Long-term use of these medicines places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this study is to determine if: * it is safe to give mesenchymal stromal cells (MSCs) to kidney transplant recipients, and * the combination of the immunosuppressive (anti-rejection) study drugs plus the MSCs can allow a kidney transplant recipient to slowly reduce and/or then completely stop all anti-rejection drugs, without rejection of their kidney (renal) allograft, a process called "immunosuppression withdrawal".

Eligibility Criteria

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

Evidence of established immunity to Epstein-Barr Virus (EBV) as demonstrated by serologic testing

I have had CMV before, and my donor is CMV positive.

I am not pregnant and agree to use effective birth control during and for 18 months after treatment.

+3 more

Exclusion Criteria

Recipient must not have active autoimmune disease, uncompensated heart failure, active severe infection, recent use of investigational drugs, medical conditions incompatible with trial participation, or unwillingness to comply with protocol monitoring and therapy

I do not have any immune deficiency or hepatitis.

I haven't had cancer, except for certain skin cancers or cervical cancer, in the last 5 years.

+5 more

Participant Groups

The study tests if mesenchymal stromal cells (MSCs) are safe for kidney recipients and if they help reduce or stop anti-rejection drugs without organ rejection. It involves multiple anti-rejection medications like alemtuzumab, belatacept, sirolimus, mycophenolate acid/mofetil, prednisone.

2Treatment groups

Experimental Treatment

Group I: MSCs 10^5 cells/kg+anti-rejection drugsExperimental Treatment7 Interventions

If the first 3 infusions of 10\^4 donor-derived Mesenchymal Stromal Cells (MSCs) cells/kg are well tolerated, this cohort of 2 participants will receive 12 infusions of 10\^5 cells/kg every 4-weeks.

Group II: MSCs 10^4 cells/kg+anti-rejection drugsExperimental Treatment7 Interventions

The first dosing cohort of 2 participants will receive 12 infusions of 10\^4 donor-derived Mesenchymal Stromal Cells (MSCs) cells/kg every 4-weeks.

Alemtuzumab is already approved in United States, European Union, European Union for the following indications:

🇺🇸 Approved in United States as Campath for: