Could a stem cell shot free liver transplant patients from a lifetime of pills?
NCT ID NCT07269041
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a donor stem cell infusion can retrain the immune system to accept a liver transplant without lifelong anti-rejection drugs. Twelve adults who had a liver transplant from a matched living donor at least one year ago will receive the infusion after a mild conditioning regimen. The goal is to see if they can safely stop all immunosuppressants within a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Donor stem cell infusion
- What this could lead to
- If successful, this could allow liver transplant recipients to stop taking lifelong immunosuppressive drugs, reducing serious side effects.
- What could go wrong
- This is an early, small study with only 12 participants. The conditioning regimen carries risks like infection or graft rejection, and the approach may not work for everyone.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jan 2033
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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 liver transplant from a living donor with a donor-recipient match at 6 or more out of 12 alleles across the HLA-A, -B, -C, -DR, -DQ, and -DP loci, as determined by high-resolution HLA typing. 2. Pre-existing living-donor liver transplant must be 12 months to 20 years from date of scheduled HSPC infusion. 3. Agreement to participate in the study and ability to give informed consent. 4. Liver biopsy within 4 weeks of enrollment without signs of rejection. 5. Meets institutional criteria for HSPC infusion. 6. Resides or is willing to stay within 3 hours distance from UCLA Medical Center by ground transportation for the first three months of the trial at the physician's discretion. 7. No known contraindication to administration of rATG or radiation therapy. 8. If subject is a female of reproductive potential (i.e., no documented absence of ovaries or uterus, history of tubal ligation, or post-menopausal status), subject 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 following initiation of the tolerance protocol. Recipient Exclusion Criteria: 1. Major ABO incompatibility with donor. 2. Any of the following labs \> 2.0 times the upper limit of normal on screening: AST, ALT, ALP, GGT or TBil. 3. History of rejection with current HLA-matched liver transplant within the last year. 4. History of GVHD following liver transplant. 5. Positive Class II HLA Donor-Specific Antibody (DSA) or class I DSA specificity above 5,000 MFI at the time of the stem cell infusion. 6. History of multi-organ transplantation, either simultaneous or as separate events. 7. History of more than one liver transplant. 8. Known allergy to rabbit proteins. 9. History of a major post-transplant complication at investigator discretion. 10. History of active malignancy within the past 5 years except for: 1. Malignancy that has not required treatment in the past 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, DCIS). 11. Active bacterial, fungal or mycobacterial infection. 12. Clinically significant viremia from EBV, CMV, HCV or HBV PCR test within the past 3 months. 1. Significant CMV viremia is defined as greater than or equal to 137 IU/mL. 2. If CMV low-level viremia is detected, defined as 137 - 1,000 IU/mL, patients may undergo subsequent testing up to twice per week and two consecutive negative results will allow for inclusion. 13. Seropositivity for HIV 1 or 2 by 4th generation serum antibody/antigen testing, or HTLV I or II by serum antibody testing. 14. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. 15. Active extra-hepatic autoimmune disease requiring immunosuppression. 16. Autoimmune disease was the indication for liver transplantation. 17. Any condition that precludes the ability to give informed consent and/or places the subject at high risk for non-compliance with the safety monitoring requirements of the study. 18. Received immunotherapy drugs, such as immune checkpoint inhibitors (e.g. pembrolizumab, nivolumab, and ipilimumab), tumor necrosis factor inhibitors, rituximab, or interleukin-2 within six months of the study treatment. 19. Use of medications with known hepatotoxicity or potential to confound interpretation of liver function tests (e.g., methotrexate, isoniazid, amiodarone), unless reviewed and approved by the Principal Investigator and hepatology, and the subject has demonstrated stable liver function tests for ≥6 months while on the medication. 20. Active hepatobiliary and pancreatic diseases: 1. History of chronic hepatobiliary or pancreatic disorders that may interfere with safety assessments or interpretation of protocol endpoints, including but not limited to primary sclerosing cholangitis (PSC), autoimmune hepatitis, primary biliary cholangitis (PBC), chronic pancreatitis, recurrent cholangitis, biliary strictures, biliary obstruction, untreated bile duct injury, hepatobiliary malignancy, or metabolic/genetic liver disease (e.g., Wilson's disease, alpha-1 antitrypsin deficiency). 2. Active chronic liver diseases such as metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-associated liver disease. 3. Gallbladder diseases such as cholecystitis or symptomatic cholelithiasis. Donor Inclusion Criteria: 1. Males and females ages 18 years and older meeting the HLA-matching requirements specified in the "Recipient Inclusion Criteria" above. 2. Must meet the following criteria for HSPC donation: 1. Hgb: \> 11 g/dl 2. Plt: \> 80,000/µL 3. WBC: \> 3,000/µL Donor exclusion criteria: 1. Major ABO incompatibility with recipient. 2. 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). 3. Pregnant (confirmed by urine or serum pregnancy test) or lactating. 4. Seropositivity for HIV 1 or 2 by 4th generation serum antibody/antigen testing, HTLV I or II by serum antibody testing. 5. Active West Nile Virus infection. 6. Active bacterial, fungal, mycobacterial or viral infection (including active hepatitis B and/or C). 7. Psychiatric, addictive, neurological, or other disorder that compromises ability to give true informed consent for participation in this study 8. Use of oral anticoagulants within two days of apheresis. 9. History of active malignancy within the past 5 years except for: 1. Malignancy that has not required treatment in the past 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, DCIS).
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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UCLA Health 200 Medical Plaza
RECRUITINGLos Angeles, California, 90095, United States
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