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Stem Cell Therapy

Stem Cell Infusion for Kidney Transplant Tolerance

Phase 1
Recruiting
Led By Jeffrey Veale, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of rejection with current HLA matched kidney transplant
Recipient is without post-transplant major complications, including de novo malignancy, active infection or rejection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Study Summary

This trial will study whether patients with a kidney transplant from a HLA-identical living donor can stop taking immunosuppressive drugs without damaging the transplanted kidney, by receiving hematopoietic stem cells from the same donor.

Who is the study for?
Adults over 18 with a well-functioning kidney transplant from an HLA-identical living donor can join. They must have good physical function, heart and liver health, no major post-transplant complications or rejection history, and stable kidney function. Women of childbearing age must use contraception.Check my eligibility
What is being tested?
The trial tests if patients can stop taking anti-rejection drugs after receiving stem cells from their kidney donor. It includes a conditioning regimen with total lymphoid irradiation and rabbit anti-thymocyte globulin before the stem cell infusion.See study design
What are the potential side effects?
Potential side effects include reactions to rabbit proteins, changes in blood counts due to radiation or rATG treatment, increased risk of infections, and possible organ inflammation related to the immune system's response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My current kidney transplant has not been rejected.
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I haven't had major issues like new cancer, infections, or rejection after my transplant.
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My heart pumps well, with an ejection fraction of 40% or higher.
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I have no known allergies or adverse reactions to rATG or radiation.
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I am able to care for myself but may not be able to do active work.
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I am 18 or older and have a kidney transplant from a matching living donor.
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My kidney function has been stable for at least 3 months.
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My liver tests are within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic immunosuppression
Secondary outcome measures
Graft survival
Incidence of allograft rejection

Trial Design

1Treatment groups
Experimental Treatment
Group I: Immune tolerance in HLA-identical kidney transplant recipientExperimental Treatment1 Intervention
We seek to establish immunological tolerance in patients with a pre-existing, well- functioning kidney transplant from an HLA-identical donor. Patients will undergo conditioning with TLI and ATG, followed by infusion of hematopoietic stem cells from the same donor . We will evaluate whether recipients can be withdrawn from immunosuppressive drugs without compromising allograft function. At serial time points, graft function will be monitored, and chimerism will be measured. Weaning of tacrolimus will begin at 6 months, with a goal of drug discontinuation within 12 months if the following conditions are met: (1) chimerism (defined as ≥1% donor type cells among the T cells, B cells, NK cells, and granulocytes) is detectable for at least 180 days, (2) stable graft function (defined as eGFR >30 mL/min and no greater than sustained 30% change over 3 months from baseline) without clinical rejection episodes is maintained, and (3) no evidence of graft vs. host disease (GVHD).

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,279,466 Total Patients Enrolled
1 Trials studying Immunological Tolerance
16 Patients Enrolled for Immunological Tolerance
Jeffrey Veale, MDPrincipal InvestigatorProfessor of Urology
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

Hematopoietic Stem Cell Infusion (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05525507 — Phase 1
Immunological Tolerance Research Study Groups: Immune tolerance in HLA-identical kidney transplant recipient
Immunological Tolerance Clinical Trial 2023: Hematopoietic Stem Cell Infusion Highlights & Side Effects. Trial Name: NCT05525507 — Phase 1
Hematopoietic Stem Cell Infusion (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525507 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have Conditioning and Stem cell infusion been officially recognized by the FDA?

"With limited evidence to support safety and efficacy, our experts at Power assigned a score of 1 when evaluating the risk associated with Conditioning and Stem Cell infusion."

Answered by AI

Are there any opportunities for participants to join this experiment?

"This particular medical trial is no longer recruiting patients, as indicated by clinicaltrials.gov; it was initially posted on September 1st 2022 and its latest revision occurred on the last day of August. Fortunately, there are 603 other studies that are presently looking for participants to join their trials."

Answered by AI
~7 spots leftby Sep 2026