Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)
Completed · Phase 3 · NCT03279081
Conditions: Crohn's Disease
At a glance
- Research payments reported, 2025
- $67,259
- U.S. investigators named
- 7
- Sites paid
- 7
- Planned or actual enrollment
- 568
About the trial
- Sponsor
- Tigenix S.A.U.
- Tested
- Cx601 (drug), Placebo (other)
- Dates
- Started 2017-09-15; completion 2023-07-26
- Results posted
- Yes
The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (\>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.
From ClinicalTrials.gov, last updated 2024-09-19. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Takeda Pharmaceuticals U.S.A., Inc. reported $67,259 in research payments for this study in 2025 (10 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Shabana F. Pasha, M.D. Gastroenterology · Scottsdale, AZ
- John R. Monson, M.D. Colorectal Surgery · Danbury, CT
- Mojtaba S. Olyaee, M.D. Gastroenterology · Kansas City,, KS
- Guy R. Orangio, MD Colorectal Surgery · New Orleans, LA
- Corey Siegel, M.D. Gastroenterology · Lebanon, NH
- David P. Hudesman, M.D. Gastroenterology · New York, NY
- James F. Marion, MD Gastroenterology · New York, NY
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Ochsner Lsu Health Shreveport, LA $35,156
- Adventhealth Orlando, FL $14,518
- Dartmouth Hitchcock Clinic $12,457
- Mount Sinai Hospital, NY $3,713
- Mayo Clinic Hospital, AZ $974
- NYU Langone Hospitals, NY $366
- Kumc Research Institute Inc $75
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.