Overview

Long-term Safety and Efficacy of Adipose-derived Stem Cells to Treat Complex Perianal Fistulas in Patients Participating in the FATT-1 Randomized Controlled Trial

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cellerix
Tigenix S.A.U.
Treatments:
Fibrin Tissue Adhesive
Criteria
Inclusion Criteria:

- At least 1 dose of the treatment assigned in the FATT-1 trial

- Informed consent

Exclusion Criteria:

- Other experimental drugs other than Cx401 during the follow-up period