Stem cells injected into artery to tame gut disease?
NCT ID NCT04312113
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether delivering a patient's own stem cells directly into the artery that supplies the colon is safe for people with moderate to severe ulcerative colitis. Twenty adults who have not responded to at least two standard treatments will receive one dose. The main goal is to check for side effects; researchers will also look for signs of healing in the gut lining.
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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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2020
- Expected to finish
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Dec 2026
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males and Females 18-65 years of age. * Moderate to Severe medically refractory inflammatory ulcerative colitis: * as defined by a an Adapted Mayo Score of 5to 9 points * including an endoscopic sub-score of 2 or 3 * Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, and anti-integrin therapy are permitted. * To meet the definition of refractory UC, all patients must have failed at least 2 standard FDA approved medications for the treatment of UC * Current standard therapy includes 5-ASA products, thiopurines, anti-TNF therapy, ustekinemab, vedolizumab, and tofacitinib (i.e. all FDA approved therapies for UC). * Refractory and failure to response is defined as continued symptoms despite 12 weeks of therapy at FDA approved doses by product necessitating change in medical strategy or referral for colectomy. * All patients should have undergone a colonoscopy in last 12 months to rule out malignant or premalignant condition * Female subjects that are of child bearing potential must to agree to use effective contraception method(s) for the duration of the study * Hemoglobin must be greater than 8 * INR must be less than 1.5 * Ability to comply with protocol * Competent and able to provide written informed consent Exclusion Criteria: * Inability to give informed consent. * Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient. * Specific exclusions; Known history of hepatitis B, C, or HIV * Patients that have had a partial colectomy * Patients that have underlying vasculitis or have been diagnosed with an underlying condition that predisposes to developing blood clots. * History of cancer including melanoma (with the exception of localized skin cancers) * Investigational drug within thirty (30) days of baseline * History of clinically significant auto-immunity (other than UC) or any previous example of fat-directed autoimmunity. Note that auto-immmunity is defined as a systemic immune mediated disease for which the antigen is known or unknown. Autoimmune diseases other than UC are excluded. Extraintestinal manifestations of UC (specifically joint inflammation, eye inflammation, PSC, skin manifestations- i.e. pyoderma gangrenosum, erythema nodosum) will be allowable. * Allergic to local anesthetics * Pregnant patients or trying to become pregnant or breast feeding. * Neoplasia of the colon and preoperative biopsy * C. Difficile infection within 30 days of study injection * Diagnosis of indeterminate colitis or suspicion of CD * Subjects with fulminant colitis, toxic megacolon, with ostomy, or ileoanal pouch * History or demonstration of pathology related to adipose tissue * Any other indication determined by the PI to be counter indicated for participation on this trial.
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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.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Other studies related to the condition(s) this trial covers.
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