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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)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase-III Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre 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 Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow up Period up to 52 Weeks
 
Region Sponsors
California - Northern
Tigenix, S.A.U.
 
Acronym KP IRB No.
ADMIRE-CD 1381312
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with confirmed Crohn's Disease.
 
Purpose
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.
 
Detailed Description
This study is to assess the efficacy and safety of Cx601, eASC, for the treatment of complex perianal fistulas in participants with Crohn's disease. The study will enroll approximately 600 participants. Cx601 eASCs intralesional injection. Placebo - Cx601 placebo-matching eASCs intralesional injection. Study treatments will be allocated, on a 1:1 ratio, by central randomization through interactive web response system (IWRS). The study will follow an add-on design, participants receiving any ongoing concomitant medical treatment, at stable doses at the time of screening, for the CD will be allowed to continue it throughout the study. The primary efficacy analysis, will be conducted at Week 24 timepoint. The double blind design will be maintained up to Week 52 (both participant and investigator) by a specific blinding for study treatment administration and for evaluating its efficacy. This multicenter trial will be conducted globally across 150 centers. The overall time to participate in this study is approximately 5 years.
 
Gender Age Limit
Male & Female 18 - 75 years
 
Inclusion Criteria
  • Signed informed consent
  • Participants of either gender greater than or equal to (>/=) 18 years and less than or equal to (
  • Participants with CD diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria
  • Presence of complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment, a central reading of a locally performed contrast enhanced (gadolinium) pelvic MRI will be performed to confirm location of the fistula and potential associated perianal abscess(es). Fistula(s) must have been draining for at least 6 weeks prior to Screening visit. Actively draining simple subcutaneous fistula(s), at the time of Screening visit, are not allowed in this study. A complex perianal fistula is defined as a fistula that meets one or more of the following criteria : #. High inter-sphincteric, high trans-sphincteric, extra-sphincteric or suprasphincteric, #. Presence of >/=2 external openings, #. Associated perianal abscess(es). Note: Abscesses that are larger than 2 cm at least 2 dimensions on MRI must be confirmed to have been drained adequately by the surgeon during the preparation curettage in order to be eligible
  • Please contact study team for more eligibility criteria
 
Exclusion Criteria
  • Concomitant rectovaginal or rectovesical fistula(s)
  • Participant na├»ve to prior specific medical treatment for complex perianal fistula(s) including immunosuppressant (IS) or anti-TNFs
  • Presence of a perianal collection >/=2 cm in at least two dimensions on the central reading MRI at Screening visit that was not adequately drained as confirmed by the surgeon during the preparation procedure (week -3 to day 0)
  • Severe rectal and/or anal stenosis and/or severe proctitis (defined as the presence of large >/=0.5 cm diameter] ulcers in the rectum) that make impossible to follow the surgery procedure manual
  • Participant with diverting stomas
  • Active, uncontrolled infection requiring parenteral antibiotics
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Crohn's disease
  • Inflammatory Bowel Diseases
  • Digestive System Diseases
  • Intestinal Diseases
  • Fistula
  • Pathological Conditions, Anatomical
  • Gastroenteritis
  • Gastroenterology
  • Gastrointestinal Diseases
 
KP Clinical Facility
  • San Francisco Medical Center
 
Clinical Area
  • Gastroenterology


Principal Investigator:
Fernando S Velayos, MD
Contact Information:
- Catherine Vowels
-415-833-3485
-catherine.vowles@kp.org
-San Francisco Medical Center


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