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)
(ADMIRE-CD-II Trial)
Recruiting in Palo Alto (17 mi)
+158 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Tigenix S.A.U.
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
SD
Study Director
Principal Investigator
Takeda
Eligibility Criteria
Inclusion Criteria
Signed informed consent
Participants of either gender >= 18 years and <= 75 years of age
Participants with CD diagnosed at least 6 months prior to Screening visit
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Exclusion Criteria
Congenital or acquired immunodeficiencies, including participants known to be HIV carriers
Severe trauma within 6 months prior to Screening visit
Participants who do not wish to or cannot comply with study procedures
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Treatment Details
Interventions
- Cx601 (Stem Cell Therapy)
- Placebo (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cx601Experimental Treatment1 Intervention
Cx601 expanded adipose-derived stem cells (eASCs) 120 million cells (5 million cells per mL) was administered once by local injection.
Group II: PlaceboPlacebo Group1 Intervention
Placebo (saline) 24 milliliters (mL) was administered once by local injection.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Digestive Health Center of LouisianaBaton Rouge, LA
University of Nevada School of MedicineLas Vegas, NV
North Shore University Hospital - GastroenterologyManhasset, NY
Carle Foundation HospitalUrbana, IL
More Trial Locations
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Who Is Running the Clinical Trial?
Tigenix S.A.U.
Lead Sponsor
Trials
11
Patients Recruited
1,500+