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Stem cell shot may free kidney patients from lifelong pills

NCT ID NCT05525507

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests whether a stem cell infusion from the same donor can allow kidney transplant recipients to safely stop taking lifelong anti-rejection medications. Ten adults with a well-functioning kidney from a matched living donor will receive a conditioning treatment followed by the stem cell infusion. The goal is to see if the body can accept the kidney without ongoing drugs, but participants may still need long-term medication if the approach fails.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Recipient Inclusion Criteria: 1. Males and females ages 18 years and older with a pre- existing kidney transplant from an HLA-matched living donor. 2. Pre-existing living kidney transplant must be within 3 months to 5 years from date of scheduled HPSC infusion. 3. No history of rejection with current HLA matched kidney transplant. 4. Recipient is without post-transplant major complications, including de novo malignancy, active infection or rejection. 5. Stable renal function determined per investigator discretion. 6. Agreement to participate in the study and ability to give informed consent. 7. Meets institutional criteria for HSPC infusion. 8. Resides or is willing to stay within 3 hours distance from UCLA Medical Center by ground transportation for the first three to six months of the trial at the physician's discretion. 9. No known contraindication to administration of rATG or radiation. 10. If participant is a female of reproductive potential (i.e., no documented absence of ovaries or uterus, history of tubal ligation, or post-menopausal status) participant must be confirmed not pregnant by a serum or urine pregnancy test) and must agree to practice a reliable form of contraception including hormonal treatments, barrier methods or intrauterine device for at least 12 months post-transplant. 11. Karnofsky Performance Score (KPS) ≥ 70. 12. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 40% by MUGA (Multi Gated Acquisition) scan or echocardiogram. 13. Adequate liver function defined as total bilirubin ≤ 1.5 times the upper limit of normal and AST/ALT ≤ 2.0 times the upper limit of normal. 14. Adequate social support based on evaluation by the UCLA bone marrow and/or renal transplant team. Recipient Exclusion Criteria: 1. Donor is identical twin. 2. Major ABO incompatibility with donor 3. Positive HLA Donor-Specific Antibody (DSA) 4. History of multi-organ transplantation 5. History of rejection with current HLA-matched kidney transplant 6. Known allergy to rabbit proteins 7. History of post-transplant major complications, including de novo malignancy, active/chronic infection or rejection, with the exception of low risk, early-stage malignancy with ≥90% 5-year survival not receiving chemotherapy or immunotherapy and non-melanomatous skin cancer. 8. History of active malignancy within the past 5 years with the exception: 1. Low risk cancer on active surveillance 2. Malignancy treated with curative intent with no known active disease \>2 years before the first dose of study treatment and of low potential risk for recurrence 3. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease 4. Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, and DCIS) 9. Worsening renal functioning over preceding 3-month interval determined per investigator discretion. 10. Pregnant (confirmed by urine or serum pregnancy test) or lactating. 11. Leukopenia (with a white blood cell count \< 3,000/µL) or thrombocytopenia (with a platelet count \< 70,000/µL). 12. EBV, CMV and BK PCR negative at time of HPSC infusion is preferred, but if they have had a history of + CMV/BK PCR, it should be resolved by 3 months. 13. Active bacterial, fungal, mycobacterial, or viral infection (including active hepatitis B and/or C). 14. Seropositivity for HIV 1 or 2 by 4th generation serum antibody/antigen testing, or HTLV I or II by serum antibody testing. 15. Renal disease with high risk of recurrence (i.e., focal segmental glomerulosclerosis). 16. Advanced hepatic fibrosis or cirrhosis secondary to hepatitis B and/or C diagnosis. 17. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; active extra-renal autoimmune disease requiring immunosuppression. 18. Active extra-renal autoimmune disease requiring immunosuppression. 19. Neuropsychiatric illness that precludes the ability to give informed consent and/or places the participant as high risk for non-compliance with the safety monitoring requirements of the study. 20. May not have received other immunomodulatory agents, including but not limited to tumor necrosis factor inhibitors within six months of the study treatment. Use of corticosteroids prescribed for a time-limited indication (\</= 4 weeks) and stopped at least 4 weeks before the kidney transplant is acceptable. 21. May not have received immunotherapy drugs such as immune checkpoint inhibitors (e.g. pembrolizumab, nivolumab, and ipilimumab), tumor necrosis factor inhibitors, rituximab, and interleukin-2 within six months of the study treatment. 22. Current or active abuse of alcohol and/or drugs within last 6 months. 23. Body Mass Index (BMI) ≥ 40. Donor Inclusion Criteria: 1. HLA-matched sibling on high-resolution HLA typing who a. is ≥18 years of age. 2. Must meet institutional criteria for HSPC transplant donation. 3. Medically fit to tolerate peripheral blood apheresis, including weighing ≥110 pounds, hemoglobin ≥11, white blood cell count ≥ 3,000/µL, and platelets ≥ 100,000/µL. 4. Serum creatinine as expected post-kidney donation and coagulation parameter studies; or, if abnormal, the changes are not considered clinically significant. Donor exclusion criteria: 1. Recipient is identical twin. 2. Major ABO incompatibility with recipient. 3. Medically unfit to tolerate peripheral blood apheresis (e.g. small body size, poor vascular access, not a suitable candidate for placement of a central catheter). 4. Pregnant (confirmed by urine or serum pregnancy test) or lactating. 5. Seropositivity for HIV 1 or 2 by 4th generation serum antibody/antigen testing, HTLV I or II by serum antibody testing 6. Active West Nile Virus infection. 7. Active bacterial, fungal, mycobacterial or viral infection (including active hepatitis B and/or C). 8. Psychiatric, addictive, neurological, or other disorder that compromises ability to give true informed consent for participation in this study. 9. History of active malignancy within the past 5 years with the exception: 1. Low risk cancer on active surveillance 2. Malignancy treated with curative intent with no known active disease \>2 years before the first dose of study treatment and of low potential risk for recurrence 3. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease 4. Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, and DCIS) 10. No use of oral anticoagulants 2 days prior to apheresis. Note: Use of aspirin and non-steroidal anti-inflammatory drugs, for pain and inflammation management purposes, are permitted to enroll in the study, but these drugs must be stopped 7 days prior to apheresis, however subjects who are taking aspirin for its anti- platelet/anti-thrombotic effect, are excluded.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.