A Phase 1 interventional study of Mesenchymal Stem Cells (MSCs) in Pouchitis, Crohn's Disease and Ulcerative Colitis Chronic, sponsored by The Cleveland Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by The Cleveland Clinic · Phase 1, Interventional, and Treatment
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.
Proctocolectomy with ileal pouch anal anastomosis (IPAA) remains the procedure of choice for patients with chronic ulcerative colitis (CUC). IPAA allows at-risk tissue to be removed with restoration of intestinal continuity while maintaining favorable long-term functional outcomes and quality of life.
While less than 30% of patients experience short-term postoperative morbidity following IPAA, up to 15% of pouches will ultimately fail due to technical or inflammatory complications, the majority of which manifest as a fistula from the pouch to the perianal or vaginal locations. After anastomotic leak, the second leading cause of pouch fistulas is the development of Crohn's disease of the pouch. While the majority of pouches are constructed for CUC, up to 25% will end up having a change in diagnosis to CD which manifests as refractor pouchitis, strictures of the proximal small bowel, or most often as peripouch fistulas. Pouch failure due to refractory pouchitis are notoriously difficult to treat, and reconstructive pouch surgery or transanal repairs are often not offered due to suspicion of recurrent pouchitis following pouch reconstruction. The reality is that patients with refractory pouchitis will end up with a major reconstructive transabdominal operation in a select few for attempt at pouch salvage, or, most likely, a permanent end ileostomy after pouch excision. This can be a devastating outcome in some patients as it impacts body image and quality of life.
Similar to refractory pouchitis, Crohn's related perianal and rectovaginal fistula are other phenotypes of inflammatory bowel disease that are also notoriously difficult to treat with conventional medical and surgical options. Despite an ever expanding repertoire of biologic therapy and surgical intervention, sustained healing rates are less than 30%. This has driven investigators to search for alternative approaches, and in 2003 investigators reported successful healing of a refractory Crohn's rectovaginal fistula following injection of mesenchymal stem cells (MSCs). Following this success, several phase I, II, and III trials designed to study the safety and efficacy of MSCs for perianal CD, all of which have reported encouraging results with superior efficacy compared to conventional medical and surgical therapies. Over 300 perianal CD patients have now been treated without increase in adverse events and no risk of incontinence.
Given the high safety profile, and substantial success in treating perianal CD, the investigators are using a GMP grade allogeneic adipose derived MSCs to establish safety and secondarily monitor for healing in patients with medically refractory pouchitis. This trial will use allogeneic bone marrow derived mesenchymal stem cells (MSCs) to produce regenerative signals which alter the ileal pouch microbiome and local inflammatory mileau. Patients with CD of the pouch suffer chronic immunosuppression and surgical intervention and desperately need an improved therapeutic. The research aims to address the root cause of this inflammation, especially the interactions of the intestinal microbiome and host immune response through a novel therapeutic approach. The specific rationale for MSCs in medical refractory pouchitis is based opon 1) their anti-inflammatory properties; 2) published experience of MSC in this condition and perianal Crohn's fistula demonstrating efficacy and safety; 3) existence of cGMP methods for their isolation and growth.
The study will enroll adult patients with medically refractory pouchitis, whose next option in the treatment plan would be major reconstructive abdominal surgery or pouch excision with a permanent end ileostomy.
50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.
Browse Pouchitis studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Specific exclusions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Submucosal endoscopic injection of 60 million allogeneic bone marrow derived mesenchymal stem cells (MSCs) into ileal pouch at baseline and possibly again after 3 months if not completely healed.
Drug: Mesenchymal Stem Cells (MSCs)
Endoscopic injection of allogeneic bone marrow derived mesenchymal stem cells (MSCs) to the ileal pouch.
Also known as: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (MSCs)
Adverse Events
Number of adverse events that occur throughout the study.
Time frame: Change from Baseline over 12 months after the MSC injection
Healing
PDAI endoscopic activity less than or equal to 1, Clinical PDAI score less than or equal to 2, and total PDAI less than or equal to 4
Time frame: Change from Baseline over 12 months after the MSC Injection
Endoscopic Remission
PDAI endoscopic activity less than or equal to 1 Mayo Endoscopic score less than or equal to 1, defined as the absence of friability or ulceration
Time frame: Change from Baseline over 12 months after the MSC Injection
Clinical Remission
Clinical PDAI score less than or equal to 2 MDPAI score less than or equal to 4
Time frame: Change from Baseline over 12 months after the MSC Injection
Endoscopic Improvement
Reduction in the endoscopic PDAI score, but still greater than 1 Reduction in the Mayo endoscopic score, but still greater than 1 Reduction in endoscopic MPDAI score by 2 or more points
Time frame: Change from Baseline over 12 months after the MSC Injection
Clinical Improvement
Reduction in the clinical PDAI score of 2 or more points Reduction in the Clinical MPDAI score of 2 or more points Decrease in 24-hour stool frequency
Time frame: Change from Baseline over 12 months after the MSC Injection
Partial Clinical Healing measured with the Pouchitis Disease Activity Index No No response
No improvement in the PDAI overall, endoscopic, or clinical scores No decrease in Mayo endoscopic severity score No decrease in 24 hour stool frequency
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Partial Clinical Healing
Decrease in C-reactive protein serum levels by greater than 50%
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Partial Clinical Healing
Decreased mucosal ulceration on pouchoscopy
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Partial Clinical Healing
Improved healing on endoscopic biopsy or surgical pathology as compared to pre-MSC delivery endoscopic biopsies.
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months after MSC injection
Assess for alloimmune response
Measure HLA Class B Antibody Screening
Time frame: Baseline, 1 month, 3 month, 12 month after MSC injection
Plan to share: No
Start is estimated for Apr 2022; primary completion for Feb 2024, 22 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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