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Can donor stem cells help intestinal transplant patients ditch heavy meds?
NCT ID NCT04804891
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether giving intestinal transplant patients stem cells from their organ donor can safely allow them to take less immunosuppression medication. The goal is to reduce the high risk of infections and cancers caused by these drugs. Six participants will receive a single infusion of donor bone marrow stem cells, and researchers will monitor for side effects like graft-versus-host disease and how well the transplant survives.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- donor bone marrow stem cells (CD34+ cells)
- What this could lead to
- If successful, this approach could allow intestinal transplant patients to take less immunosuppression medication, reducing their risk of serious infections and certain cancers while still preventing organ rejection.
- What could go wrong
- This is a very early, small phase 1 trial with only 6 participants, so results may not apply broadly. There is a risk of graft-versus-host disease (GVHD), where donor cells attack the recipient's body, and the strategy may not effectively reduce immunosuppression.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Dec 2028
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 to 65 years
- 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.
Inclusion Criteria: * All patients actively listed as candidates for intestinal or multi-visceral transplant at the study site; while all patients who are actively listed in United Network for Organ Sharing (UNOS) for intestinal and/or multi-visceral transplantation, including those who have previously received a multi-visceral transplant and are re-listed, are eligible for participation, the following are examples of listing criteria suitable for enrollment in this clinical trial: * Short Bowel Syndrome (SBS) due to: * Trauma (multiple resections/explorations and/or vascular abdominal trauma superior mesenteric artery (SMA) / superior mesenteric vein (SMV) injuries) * Gastroschisis * Volvulus * Necrotizing Enterocolitis * Intestinal Atresia * Crohn's Disease * Hirschprung's Disease * Chronic Intestinal Pseudo-Obstruction * Malabsorption: * Microvillus Inclusion Disease * Tufting Enteropathy * Complete portomesenteric thrombosis with cirrhosis * Slow-growing, low-malignancy potential tumors infiltrating mesenteric root: * Gardner's Syndrome * Familial Adenomatous Polyposis * Desmoid Tumor with Intra-Abdominal Infiltration * Endocrine Tumors * Re-transplant candidates who lost the first graft to rejection or patients who have higher risk of toxicity from chronic long term immunosuppression (i.e., patients with chronic kidney disease) * Patient commits to planned follow up at a study site for the 48-month duration of study procedures * Age ≥18 years old and ≤65 years old * Subjects or capable of signing the informed consent document themselves Exclusion Criteria: * Active systemic infection with hemodynamic instability and/or sepsis * Patients with known immunodeficiency syndrome * Carcinoma with metastasis (except neuro-endocrine tumors, even in the presence of metastasis these patients may undergo multivisceral/cluster transplantation) * Severe cardiovascular and/or respiratory instability, as defined by requirement of pressors or ventilator * Severe cerebral edema, with radiologic findings of effaced sulci and/or herniation * Poorly controlled hypertension (systolic blood pressure \> 170 on at least 2 occasions), diabetes mellitus (HbA1c \> 8), or uncontrollable seizure disorders * Age \> 65 years * Documented history of non-compliance with medical therapy and follow-up * Substance addiction in the last six months * Psychosocial Instability: absence of a consistent reliable social support system * Significant or active psychiatric disorder associated with the inability to cooperate or comply with medical therapy * In the judgement of the clinical team, severely limited functional status with poor rehabilitation potential * Multi-organ failure and preceding CD34+ infusion * Pre formed panel reactive antibodies (PRA) mean fluorescein intensity (MFI) \> 5000 by Luminex * Patients who are pregnant or breast-feeding or intend to get pregnant during the study period * Patients who have developed moderate or severe rejection before post-transplant day 11 * Vulnerable populations, such as incarcerated or institutionalized individuals * Subjects with clinical features suggestive of GVHD * Subjects who are hemodynamically unstable (i.e., requiring vasopressor support) * Female subjects of childbearing age and male patients who are not using and/or unwilling to use an effective method of birth control for the duration of the trial activities * History of previous hematopoietic progenitor cell (HPC) infusion or transplant of any kind. Note: Human leukocyte antigen (HLA) mismatch will not be one of the exclusion criteria
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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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Columbia University Irving Medical Center/NYP
RECRUITINGNew York, New York, 10032, United States
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