AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via P… (NCT02677350) | Clinical Trial Compass
WithdrawnPhase 1
AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE)
Stopped: Study is permanently closed to enrollment
0Started 2019-12-01
Plain-language summary
To evaluate the role of allogeneic mesenchymal stem cells for treatment of perianal fistulizing Crohn disease.
Twenty (20) Crohn's disease patients with complex or multiple perianal or rectovaginal fistulas will be included and will be scheduled to undergo peri-fistula injections after meeting all inclusion/exclusion criteria's at baseline.
Following the Pilot Phase of four (4) subjects, sixteen (16) subjects are scheduled to undergo perianal injections and after meeting all inclusion/exclusion criteria's, will be evaluated at baseline.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provide written informed consent.
✓. Male and Female subjects ≥ 18 years of age at the time of signing the Informed Consent Form.
✓. Subjects with Fistulizing Crohn´s disease with complex perianal fistula, multiple perianal fistulas, or rectovaginal fistula(s). The complex perianal fistula is defined as a trans-sphincteric, supra-sphincteric or an extra-sphincteric tract. Patients with multiple fistulas, "horseshoe" fistula," or any fistula with fecal incontinence as a result of the Crohn's disease itself or because of previous anal fistula surgery that cannot have more surgery are also eligible.
✓. If drainage of abscess is needed, it should be done 2 or more weeks prior to onset of therapy.
✓. Have had Crohn's Disease (CD) diagnosed at least 6 months prior to enrollment based on clinical, endoscopic, anatomic/pathologic and/or radiologic criteria.
✓. Have a CDAI score \<350.
✓. During the course of the subject's Crohn's disease (CD), subject must have received anti-Tumor Necrosis Factor (TNF) agents or immunomodulators which did not heal the CD fistulas. If anti-TNFs or immunomodulators are contraindicated or led to adverse events, patients must have failed conservative therapy with antibiotics, or setons, or surgical intervention.
✓. Subject who are currently receiving anti-TNFs, antibiotics, 5-aminosalicylic acid, azathioprine, 6-mercaptopurine, methotrexate, prednisone, or any similar drugs at the time of enrollment as long as the following criteria are met:
Exclusion criteria
✕
What they're measuring
1
Evaluation of treatment emergent adverse events from the bone marrow-derived allogeneic mesenchymal stem cells implant
Timeframe: At each intervention and 7, 10, and 16 months after last intervention
. Have a known, serious radiographic contrast allergy (gadolinium in particular)
✕. Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet values \< 100,000/ul without another explanation.
✕. Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the Upper limit normal.
✕. Have a coagulopathy (International Normalized ratio (INR) \> 1.3) not due to a reversible cause (i.e., Coumadin). Patients on Coumadin will be withdrawn 5 days before the procedure and confirmed to have an INR \< 1.3. Patients who cannot be withdrawn from Coumadin will be excluded from enrollment.
✕. Bone marrow dysfunction, as evidenced by a 20% or more deviation from normal hematocrit, white blood cell count or platelet values without another explanation.
✕. Be an organ transplant recipient.
✕. Clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
✕. Non-cardiac condition that limits lifespan to \< 1 year.