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Stem cell shot for pouchitis fails to launch

NCT ID NCT05578508

Disease control Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to test whether injecting stem cells from a donor's bone marrow into the pouch (a surgically created internal reservoir) could safely treat pouchitis that hadn't improved with antibiotics or other drugs. The trial was planned for 12 adults aged 18-75 in the U.S., but it was withdrawn before any participants were enrolled, so no data were collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Allogeneic bone marrow derived mesenchymal stem cells (MSCs)
What this could lead to
If it had worked, this could point toward a new treatment option for people with pouchitis that doesn't respond to standard therapies.
What could go wrong
The trial was withdrawn before any patients were enrolled, so no results are available. Stem cell treatments are still experimental and may carry risks like infection or immune reactions.

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.

Expected to start

Apr 2022

An estimate. Start dates often move.

Expected to finish

Feb 2024

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 to 75 years

Sex

Anyone

Healthy volunteers

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

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

Inclusion Criteria: 1. Men and women 18-75 years of age 2. Residents of the United States 3. Medically refractory pouchitis defined as lack of response to antibiotics, immunomodulators, and/or biologics 4. Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF therapy, anti-integrin and anti-interleukin are permitted if have been on them for at least 2 months prior to study enrollment without change 5. No malignant or premalignant intestinal condition, ruled out on colonoscopy within 90 days of MSC delivery 6. Ability to comply with protocol 7. Competent and able to provide written informed consent 8. Must have failed or have a contraindication to standard medical therapy including anti-TNF, anti-interleukin, or anti-integrin agent Exclusion Criteria: 1. Inability to give informed consent 2. 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 3. Specific exclusions: * HIV * Hepatitis B or C * Abnormal CBC at screening * Abnormal AST or ALT at screening 4. History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment 5. Investigational drug use within thirty (30) days of baseline 6. Pregnant or breastfeeding 7. Multifocal proximal small bowel involvement which resembles Crohn's of the small bowel 8. Evidence of pelvic sepsis and pelvic penetrating fistulizing disease 9. Patients with intestinal diversion above the level of the pouch 10. Neoplasia of pouch 11. Change in medical regimen for pouchitis in the two months prior to study enrollment

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Conditions

The condition(s) this trial relates to.

Crohn disease ileal neoplasm inflammatory bowel disease pouchitis ulcerative colitis

As listed by the trial registrant

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

Crohn's disease Inflammatory bowel diseases Pouch, ileal Pouchitis Ulcerative colitis chronic

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

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