Complex Perianal Fistula
Conditions
Keywords
Complex perianal fistula, Adipose-derived adult stem cells, Fibrin glue
Brief 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.
Detailed 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.
Interventions
DRUGASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.
DRUGFibrin glue
After curettage, the fistulous tract was sealed with fibrin glue.
Sponsors
Tigenix S.A.U.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of adverse events (clinical or laboratory) attributed to the study therapy in the preceding FATT-1 randomized trial (CX401 or fibrin glue) | 6 months (since last visit in FATT-1 trial) |
Secondary
| Measure | Time frame |
|---|---|
| Closure of the fistula (defined as suppuration through the external opening of the fistula spontaneously and on pressure, complete re-epithelization of the external opening in the clinical evaluation and absence of collections >2 cm in MRI) | 6 months (since last visit of FATT-1 trial) |
Countries
Spain
Outcome results
None listed