Crohn's Disease Clinical Trial
Official title:
A Phase I, Pilot Trial to Evaluate the Safety and Efficacy of Injection of Allogeneic Mesenchymal Bone-Marrow Derived Human Stem Cells in Patients With Fistulizing Crohn's Disease.
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.
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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