NCT01020825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

November 25, 2009

Last Update Submit

April 10, 2019

Conditions

Complex Perianal Fistula

Keywords

Complex perianal fistulaAdipose-derived adult stem cellsFibrin glue

Outcome Measures

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)

    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)

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

Study Arms (3)

ASCs

Patients randomized to experimental treatment (ASC transplantation) in the FATT-1 randomized controlled trial \[ClinicalTrials.gov identifier: NTC00475410\]

Drug: ASCs

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

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

Interventions

ASCsDRUG

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

Also known as: Cx401 (company code), Ontaril®
ASCs
Fibrin glueDRUG

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

Fibrin glue

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • At least 1 dose of the treatment assigned in the FATT-1 trial
  • Informed consent

You may not qualify if:

  • Other experimental drugs other than Cx401 during the follow-up period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hospital Mutua de Terrasa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

Location

Hospital Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Clínica Universitaria Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Nuestra Señora de Valme

Seville, 41014, Spain

Location

Hospital Universitari Joan XXIII

Tarragona, 17300, Spain

Location

Hospital General Univeritario de Valencia

Valencia, 46014, Spain

Location

Hospital Clínico Universitario "Lozano Blesa"

Zaragoza, 50009, Spain

Location

Related Publications (5)

  • Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20.

    PMID: 12756590BACKGROUND

  • Garcia-Olmo D, Garcia-Arranz M, Herreros D, Pascual I, Peiro C, Rodriguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. doi: 10.1007/s10350-005-0052-6.

    PMID: 15933795BACKGROUND

  • Garcia-Olmo D, Herreros D, Pascual M, Pascual I, De-La-Quintana P, Trebol J, Garcia-Arranz M. Treatment of enterocutaneous fistula in Crohn's Disease with adipose-derived stem cells: a comparison of protocols with and without cell expansion. Int J Colorectal Dis. 2009 Jan;24(1):27-30. doi: 10.1007/s00384-008-0559-0. Epub 2008 Aug 12.

    PMID: 18696086BACKGROUND

  • Garcia-Olmo D, Garcia-Arranz M, Herreros D. Expanded adipose-derived stem cells for the treatment of complex perianal fistula including Crohn's disease. Expert Opin Biol Ther. 2008 Sep;8(9):1417-23. doi: 10.1517/14712598.8.9.1417.

    PMID: 18694359BACKGROUND

  • Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a.

    PMID: 22706128DERIVED

MeSH Terms

Interventions

Fibrin Tissue Adhesive

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Damián García-Olmo, MD

    General Surgery Department, Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2009

First Posted

November 26, 2009

Study Start

September 1, 2008

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

April 12, 2019

Record last verified: 2019-04

Locations

ES(15)