WithdrawnPhase 1

Stem Cells for the Treatment of Pouchitis

Stopped: PI decision not to move forward with study.

United States0Started 2022-04

Plain-language summary

The purpose of this study is to determine the safety and feasibility of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with medically refractory Pouchitis.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men and women 18-75 years of age
. Residents of the United States
. Medically refractory pouchitis defined as lack of response to antibiotics, immunomodulators, and/or biologics
. 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
. No malignant or premalignant intestinal condition, ruled out on colonoscopy within 90 days of MSC delivery
. Ability to comply with protocol
. Competent and able to provide written informed consent
. Must have failed or have a contraindication to standard medical therapy including anti-TNF, anti-interleukin, or anti-integrin agent

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Events

Timeframe: Change from Baseline over 12 months after the MSC injection

Healing

Timeframe: Change from Baseline over 12 months after the MSC Injection

Trial details

NCT IDNCT05578508

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02

View on ClinicalTrials.gov More Pouchitis trials