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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

NCT01020825 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2019-04-12

No results posted yet for this study

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.

Conditions

  • Complex Perianal Fistula

Interventions

DRUG

ASCs

Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.

DRUG

Fibrin glue

After curettage, the fistulous tract was sealed with fibrin glue.

DRUG

ASCs

Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue.

Sponsors & Collaborators

  • Tigenix S.A.U.

    lead INDUSTRY

Principal Investigators

  • Damián García-Olmo, MD · General Surgery Department, Hospital Universitario La Paz

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01020825 on ClinicalTrials.gov