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Stem Cell Transplantation

Kidney + Stem Cell Transplant for Kidney Transplant Rejection (OneLegacy Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Jeffrey Veale, MD

Eligibility Criteria Checklist

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

Must have

Males and females ages 18 years and older receiving living donor kidney transplant from an HLA-identical sibling at UCLA Medical Center

Meets institutional criteria for kidney and HSPC transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12, 24, 36, and 48 months post-kidney transplant

Awards & highlights

OneLegacy Trial Summary

This trial is for kidney transplant recipients who receive a kidney from a sibling donor, testing an investigational treatment of a drug and radiation therapy followed by an infusion of blood stem cells from the same sibling. Researchers hope this will allow patients to stop immunosuppressive medications.

Who is the study for?

This trial is for adults over 18 who need a kidney transplant and can receive one from their sibling. They must be healthy enough for the procedure, with good heart and lung function, normal blood tests, and no severe infections or recent heavy drug use. Women of childbearing age must not be pregnant and agree to use contraception.Check my eligibility

What is being tested?

The study is testing a new treatment that combines drugs (rATG), radiation therapy (TLI), and an infusion of donor stem cells after receiving a kidney from a sibling. The goal is to see if this approach helps patients accept the new organ without needing lifelong immunosuppressive drugs.See study design

What are the potential side effects?

Potential side effects may include reactions to rATG like fever or chills, risks from radiation exposure such as fatigue or nausea, complications from stem cell infusion including infection risk increase, plus general surgery-related risks.

OneLegacy Trial Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older and getting a kidney transplant from my sibling at UCLA.

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I meet the requirements for a kidney and stem cell transplant.

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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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My lung function tests are at least half of what is expected.

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My liver tests are within the required range.

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My heart's pumping ability is at least 40%.

OneLegacy Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12, 24, 36, and 48 months post-kidney transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12, 24, 36, and 48 months post-kidney transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24, 36, and 48 months post-kidney transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Withdrawal from immunosuppressive drugs

Secondary outcome measures

Graft failure

Graft rejection

Survival

+3 more

OneLegacy Trial Design

1Treatment groups

Experimental Treatment

Group I: Donor CD34+ and CD3+ cell infusionExperimental Treatment1 Intervention

The investigational products are (1) an intravenous infusion of granulocyte colony-stimulating factor (GCSF)-mobilized, Miltenyi-enriched CD34+ cells (≥ 5 million cells per kilogram) followed by (2) an infusion of CD3+ cells (5 million cells per kilogram) from an HLA-identical sibling living donor. The cells are infused around Day 11 post-transplant after the following pre-conditioning regimen: 5 doses of rATG (1.5 mg/kg IV per day for 5 days, starting on the day of transplant) 10 doses of TLI (120 centigray [cGY] x 10 fractions, starting the day after transplant)

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jeffrey Veale, MDLead Sponsor

OneLegacy FoundationUNKNOWN

1 Previous Clinical Trials

45 Total Patients Enrolled

Media Library

Donor CD34+ and CD3+ cells (Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT03707262 — Phase 1 & 2

Drug Tolerance Research Study Groups: Donor CD34+ and CD3+ cell infusion

Drug Tolerance Clinical Trial 2023: Donor CD34+ and CD3+ cells Highlights & Side Effects. Trial Name: NCT03707262 — Phase 1 & 2

Donor CD34+ and CD3+ cells (Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03707262 — Phase 1 & 2

Frequently Asked Questions

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

Are people currently able to enroll in this experiment?

"Per the data provided by clinicaltrials.gov, this research endeavour is actively soliciting participants. It was launched on November 6th 2019 and most recently updated on April 11 2022."

Answered by AI

How many participants are currently included in this research project?

"Affirmative. Clinicaltrials.gov lists this medical trial as currently enrolling patients, having first been published on November 6th 2019 and updated April 11th 2022. The investigators are in search of 15 individuals across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor

Jeffrey Veale, MD 2019. "Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03707262.