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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.
Full description
Twenty (20) subjects will be treated with 20 million (2 x 10^7) allogeneic MSC's total divided into 10 injections of 2 million cells/cm of tract in 0.5 ml volume (for total volume of 5 ml per visit) at 4 week intervals for a maximum of 4 treatment sessions based on the discretion of the endoscopist at the time of injection..
For patients with more than 6 fistula tracts, the largest of the tracts will be injected.
The first four (4) subjects that receive their initial injections will not be treated less than 5 days apart. As stated in the above response, these first four (4) patients will have an initial safety follow up period of one month prior to proceeding with the treatment of further patients.
Follow up: Clinical (CDAI, PDAI, and perianal examination +/- under anesthesia), and endoscopic ultrasound will be performed at the time of each treatment. MRI evaluation will be performed at screening, 4 weeks after the fourth treatment (week 16) and at 16 months, if fistula closure has not been achieved. Clinical evaluation will be performed at months 1, 3, 6, 12. Endoscopic ultrasound and MRI will also be performed as needed for symptomatic patients if an abscess is suspected.
Duration of Study participation: 17 Months (Follow-up visits will be at 4, 7, 10 and 16 Months post treatment.
The Allo-hMSCs will be supplied from an allogeneic human mesenchymal stem cell source manufactured by the University of Miami.
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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:
Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements
Exclusion criteria
In order to participate in this study, a patient Must Not:
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0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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