NCT00475410: FATT1

A Phase III Multicenter, Single Blind, Randomized, Comparative and add-on Clinical Trial, in Three Parallel Groups, to Evaluate Efficacy and Safety of a New Therapy With Adipose-derived Autologous Stem Cells for the Treatment of Complex Perianal Fistulas in Patients Without Inflammatory Bowel Disease

Completed Phase 3 Last updated 10 April 2019

What this trial tests

Phase 3 trial testing ASCs (Cx401, company code) in Anal Fistula in 214 participants. Completed in 1 August 2009.

Timeline

1 February 2007

Primary endpoint
1 August 2009

1 August 2009

Quick facts

Lead sponsor	Tigenix S.A.U.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	214
Start date	1 February 2007
Primary completion	1 August 2009
Estimated completion	1 August 2009
Sites	10 locations across Germany, Spain, United Kingdom

Drugs / interventions tested

• ASCs (Cx401, company code) — full drug profile →
• Fibrin adhesive — full drug profile →

Conditions studied

• Anal Fistula — all drugs for Anal Fistula →

Sponsor

Tigenix S.A.U. — full company profile →

Who can join

18 and older, any sex, with Anal Fistula. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Closure of fistulas defined as absence of suppuration and re-epithelization of the external opening and absence of collections>2 cm directly related to the fistula tract treated, as measured by MRI (healing)
  Time frame: weeks 1, 4, 12 and 24. Week 26 in patients with a second dose

Sponsor's own description

Anal fistula is defined as an abnormal communication between the anal canal and the perianal skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas. This study will test the safety and efficacy of ASCs (adipose stem cells) in the treatment of patients without Crohn´s disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities.
   Galipeau J, Sensébé L. · · 2018 · cited 1288× · PMID 29859173 · DOI 10.1016/j.stem.2018.05.004
2. Mesenchymal stromal cell therapies: immunomodulatory properties and clinical progress.
   Wu X, Jiang J, Gu Z, Zhang J, et al · · 2020 · cited 232× · PMID 32771052 · DOI 10.1186/s13287-020-01855-9
3. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation.
   Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, et al · · 2012 · cited 192× · PMID 22706128 · DOI 10.1097/dcr.0b013e318255364a
4. Adipose-Derived Stem Cells for Tissue Engineering and Regenerative Medicine Applications.
   Dai R, Wang Z, Samanipour R, Koo KI, et al · · 2016 · cited 191× · PMID 27057174 · DOI 10.1155/2016/6737345
5. Adipose-derived stromal cells: Their identity and uses in clinical trials, an update.
   Casteilla L, Planat-Benard V, Laharrague P, Cousin B. · · 2011 · cited 162× · PMID 21607134 · DOI 10.4252/wjsc.v3.i4.25
6. Foundations of gastrointestinal-based drug delivery and future developments.
   Chu JN, Traverso G. · · 2022 · cited 136× · PMID 34785786 · DOI 10.1038/s41575-021-00539-w
7. Adipose-Derived Mesenchymal Stromal Cells in Regenerative Medicine: State of Play, Current Clinical Trials, and Future Prospects.
   Laloze J, Fiévet L, Desmoulière A. · · 2021 · cited 40× · PMID 32470315 · DOI 10.1089/wound.2020.1175
8. Enhanced anti-inflammatory effects of mesenchymal stromal cells mediated by the transient ectopic expression of CXCR4 and IL10.
   Hervás-Salcedo R, Fernández-García M, Hernando-Rodríguez M, Quintana-Bustamante O, et al · · 2021 · cited 29× · PMID 33579367 · DOI 10.1186/s13287-021-02193-0