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Clinical Trial Summary

The purpose of this extension is to investigate and confirm the long-term (6 months) safety and efficacy of the preceding FATT-1 trial [ClinicalTrials.gov identifier: NTC00475410], which studied patients with perianal fistula treated having received adipose-derived adult stem cell (ASC)and/or fibrin glue.


Clinical Trial Description

Complex perianal fistulas are a source of great distress for suffers. Treatment options are limited and surgery is often associated with incontinence and recurrence.

The biological properties of stem cells derived from adult tissues make them candidates for the treatment of pathologies requiring tissue regeneration or in diseases where the healing process is altered.

This study aims to evaluate the safety and efficacy of patients having participated within a preceding multicenter, placebo-controlled, phase 3 study [ClinicalTrials.gov identifier: NTC00475410]. The present extension aims to collect safety and efficacy data for up to 12 month from initial administration.

Fistula closure is defined as absence of suppuration through the external orifice with complete re-epithelization of the external orifice and absence of collections >2cm directly related to the fistula tract treated, as measured by MRI. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01020825
Study type Observational
Source Takeda
Contact
Status Completed
Phase
Start date September 2008
Completion date May 2010

See also
  Status Clinical Trial Phase
Completed NCT04075825 - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Phase 3
Recruiting NCT04701411 - A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease Phase 3
Terminated NCT01314092 - Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula Phase 2
Active, not recruiting NCT04118088 - A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula Phase 4
Terminated NCT01378390 - Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease Phase 3
Active, not recruiting NCT04940611 - A Study of Surgical Interventions in Fistulizing Conditions
Active, not recruiting NCT04971525 - A Study to Check How Often People Treated With Darvadstrocel for Crohn's Disease Are Diagnosed With Cancer