Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this study is to determine the safety and efficacy of using remestemcel-L, an ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory ulcerative colitis. This study will enroll adult patients with medically refractory ulcerative colitis who are planning to switch biologic therapy or undergo colectomy as the next stage in their treatment plan.

Key facts

Study ID

NCT04543994

Run by

The Cleveland Clinic

People needed

7

Starts

2020-11-10

Expected to finish

2023-11-15

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and Females 18-75 years of age.
• Ulcerative colitis of at least 6 months duration with medically refractory symptoms
• Exposure to corticosteroids, 5-ASA drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 4 weeks for any monoclonal antibody is necessary.
• If receiving conventional immunomodulators (ie, AZA, 6-MP, or MTX), must have been taking them for ≥12 weeks, and on a stable dose for at least 4 weeks.
• If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks.
• If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks.
• If receiving oral corticosteroids, the dose must be ≤20 mg/day prednisone or its equivalent and must have been stable for at least 4 weeks.
• If receiving budesonide, the dose must have been stable for at least 2 weeks.
• If oral 5-ASA compounds or oral corticosteroids (including budesonide) have been recently discontinued, they must have been stopped for at least 2 weeks.
• The following medications/therapies must have been discontinued before first administration of study agent:
• TNF-antagonist therapy (eg, infliximab, etanercept, certolizumab, adalimumab, golimumab), vedolizumab, ustekinumab for at least 4 weeks.
• Cyclosporine, tacrolimus, or sirolimus, for at least 4 weeks.
• 6-thioguanine (6-TG) must have been discontinued for at least 4 weeks.
• Rectal corticosteroids (ie, corticosteroids [including budesonide] administered to the
• rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks.
• Rectal 5-ASA compounds (ie, 5-ASAs administered to the rectum or sigmoid colon viafoam or enema or suppository) for at least 2 weeks.
• Parenteral corticosteroids for at least 2 weeks.
• Total parenteral nutrition (TPN) for at least 2 weeks.
• Antibiotics for the treatment of UC (eg, ciprofloxacin, metronidazole, or rifaximin) for at least 2 weeks.
• No colonic dysplasia and malignancy as ruled out by colonoscopy within 30 days of MSC delivery
• Ability to comply with protocol
• Competent and able to provide written informed consent
• Must have lost response to at least one monoclonal antibody (anti-TNF, anti-interleukin, or anti-integrin therapy), tofacitinib, or have a contra-indication to biologic therapy
• If patient is of reproductive capacity, willing to use adequate birth control measures while they are in the study
• Exclusion Criteria for all patients to join the protocol

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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