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Monoclonal Antibodies

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

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serological evidence of prior Cytomegalovirus (CMV) infection if donor is CMV positive

Donors must have the ability to understand and provide informed consent for all study procedures including kidney transplant and bone marrow harvest

Must not have

Recipient must not have underlying renal diseases with a high likelihood of recurrence

Recipient must not have a history of active M. tuberculosis and must have completed treatment for latent M. tuberculosis with a negative chest x-ray

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from kidney transplant with alemtuzumab induction to to completion of study (up to approximately 6.5 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it is safe to give a certain type of cell, called mesenchymal stromal cells (MSCs), to kidney transplant recipients. The combination of the immunosuppressive (anti-rejection) study drugs plus the MSCs might 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".

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include increased risk of infections and cancer due to long-term immunosuppression. Specific drug-related risks range from blood cell changes with alemtuzumab to gastrointestinal issues with mycophenolate and possible diabetes or cholesterol problems with sirolimus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I understand and agree to all procedures, including kidney transplant and bone marrow harvest.

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I am an adult approved for a kidney transplant from a living donor who is not an exact HLA match.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have kidney diseases likely to come back.

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I don't have active tuberculosis and have treated any latent infection.

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I haven't had any donor-specific antibodies or taken immunosuppressive drugs in the last year.

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I have not taken any strong immune system suppressing drugs.

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I do not have any immune deficiency or hepatitis.

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I have never donated blood to the recipient, don't have CMV if they are CMV negative, and I'm free from HIV, HCV, and HBV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from kidney transplant with alemtuzumab induction to to completion of study (up to approximately 6.5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from kidney transplant with alemtuzumab induction to to completion of study (up to approximately 6.5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from kidney transplant with alemtuzumab induction to to completion of study (up to approximately 6.5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants who Achieve Operational Tolerance

Secondary study objectives

Antibodies

Frequency of Antibody-Mediated Chronic Rejection

Frequency of Select Adverse Events (AEs)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

alemtuzumab

2004

Completed Phase 4

~2760

belatacept

2017