Multicentre,Randomized,Comparative,Add-on,Into Two Parallel Groups Clinical Trial to Evaluate Efficacy and Safety of Autologous Mesenchymal Stem Cells Derived From Expanded Adipose Tissue (ASC), for Treatment of Complex Perianal Fistulizing Disease in Patients Without IBD. (FISPAC)

NCT01803347 Phase 3 COMPLETED

Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery

Details

Lead sponsor	Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Phase	Phase 3
Status	COMPLETED
Enrolment	80
Start date	2013-02
Completion	2017-10

Conditions

• Anal Fistula

Interventions

• ◦Drug: ASCs. + fibrin glue
• fibrin glue

Primary outcomes

• Safety/efficacy — 2014, march
  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) \[ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose \]

Countries

Spain