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Completed

NCT Number: NCT01020825

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

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.

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Key information

Conditions

Complex Perianal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Mutua de Terrasa, Terrassa, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASCs

Drug

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

Other names: Cx401 (company code), Ontaril®

Fibrin glue

Drug

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

Primary outcomes

  1. Cumulative incidence of adverse events (clinical or laboratory) attributed to the study therapy in the preceding FATT-1 randomized trial (CX401 or fibrin glue)

    Time frame: 6 months (since last visit in FATT-1 trial)

Secondary outcomes

  1. 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)

    Time frame: 6 months (since last visit of FATT-1 trial)

Sponsors and collaborators

Lead sponsor

Tigenix S.A.U.

Industry

Registry information

Official study title

A Prospective Study for the Assessment of the Long-term Safety and Efficacy of Cx401 in Patients Taking Part in the FATT-1 Trial

Acronym: LTE

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 26, 2009
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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