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 (LTE)

April 10, 2019 updated by: Tigenix S.A.U.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Girona, Spain, 17007
        • Hospital Doctor Josep Trueta
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Pamplona, Spain, 31008
        • Clínica Universitaria Navarra
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Seville, Spain, 41014
        • Hospital Universitario Nuestra Señora de Valme
      • Tarragona, Spain, 17300
        • Hospital Universitari Joan Xxiii
      • Valencia, Spain, 46014
        • Hospital General Univeritario de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Clínico Universitario "Lozano Blesa"
    • Barcelona
      • Terrasa, Barcelona, Spain, 08221
        • Hospital Mutua de Terrasa
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital De Fuenlabrada
    • Valencia
      • Sagunto, Valencia, Spain, 46520
        • Hospital de Sagunto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that received at least one treatment dose in study Cx401/FATT1

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ASCs
Patients randomized to experimental treatment (ASC transplantation) in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410]
Drug: ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.
Other Names:
  • Cx401 (company code)
  • Ontaril®
Drug: ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue.
Other Names:
  • Cx401 (company code)
  • Ontaril®
Fibrin glue
Patients randomized to the control treatment (application of fibrin glue) in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410]
Drug: Fibrin glue
After curettage, the fistulous tract was sealed with fibrin glue.
ASCs + Fibrin Glue
Patients randomized to the control treatment (application of fibrin glue) + intralesional injection of ASCs in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410]
Drug: ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.
Other Names:
  • Cx401 (company code)
  • Ontaril®
Drug: ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue.
Other Names:
  • Cx401 (company code)
  • Ontaril®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tigenix S.A.U.

Investigators

  • Principal Investigator: Damián García-Olmo, MD, General Surgery Department, Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (ESTIMATE)

November 26, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CX401-0303
  • EudraCT: 2008-003140-10 (OTHER: EMEA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Complex Perianal Fistula

Clinical Trials on ASCs

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe