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)

This study has been completed.
Sponsor:
Information provided by:
Cellerix
ClinicalTrials.gov Identifier:
NCT01020825
First received: November 25, 2009
Last updated: June 13, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Complex Perianal Fistula
Drug: ASCs
Drug: Fibrin glue

Study Type: Observational
Study Design: Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Cellerix:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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®
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 in combination with fibrin glue.
Other Names:
  • Cx401 (company code)
  • Ontaril®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020825

Locations
Spain
Hospital Mutua de Terrasa
Terrasa, Barcelona, Spain, 08221
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital de Fuenlabrada
Fuenlabrada, Madrid, Spain, 28942
Hospital de Sagunto
Sagunto, Valencia, Spain, 46520
Hospital Doctor Josep Trueta
Girona, Spain, 17007
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Clínico San Carlos
Madrid, Spain, 28040
Clínica Universitaria Navarra
Pamplona, Spain, 31008
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Nuestra Señora de Valme
Seville, Spain, 41014
Hospital Universitari Joan XXIII
Tarragona, Spain, 17300
Hospital General Univeritario de Valencia
Valencia, Spain, 46014
Hospital Clínico Universitario "Lozano Blesa"
Zaragoza, Spain, 50009
Sponsors and Collaborators
Cellerix
Investigators
Principal Investigator: Damián García-Olmo, MD General Surgery Department, Hospital Universitario La Paz
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lydia Dorrego, Clinical Operations Director, Cellerix
ClinicalTrials.gov Identifier: NCT01020825     History of Changes
Other Study ID Numbers: CX401-0303, EudraCT: 2008-003140-10
Study First Received: November 25, 2009
Last Updated: June 13, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Cellerix:
Complex perianal fistula
Adipose-derived adult stem cells
Fibrin glue

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014