NCT00115466

Brief Summary

This comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the non-surgical treatment of complex perianal fistula.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2005

First QC Date

June 22, 2005

Last Update Submit

June 23, 2005

Conditions

Anal Fistula

Keywords

ASCs (adult stem cells derived from adipose tissue)FistulaCell TherapyComplex perianal fistula

Outcome Measures

Primary Outcomes (1)

  • Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization)

Secondary Outcomes (1)

  • No fistula recurrence after 1 year follow-up

Interventions

Non-surgical autologous implant of ASCsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of both sexes older than 18 years of age.
  • Patients with a complex perianal fistula pathology which we define as the subjects that fulfil some of the following conditions:
  • No palpation of the fistula tract beneath the perianal skin.
  • A tract that is parallel to the rectum on exploration with a stylet.
  • Associated faecal incontinence.
  • Risk factors of anal incontinence.
  • At least one previous operation for a fistulous disorder.
  • Suprasphincteric trajectories
  • Rectovaginal fistula
  • Prior diagnosis of Crohn's disease.
  • Patients from whom written informed consent has been obtained for them to participate in the study prior to performing any procedure described in the study.
  • Patients that have already been subjected to a colonoscopy within a period of up to 6 months prior to the study.

You may not qualify if:

  • Patients that are extremely thin who should not be subjected to liposuction.
  • Known allergy to local anaesthetics or to bovine proteins
  • History of neoplasia in the past 5 years.
  • Patients with prior positive markers for any of the following pathogens: Hepatitis B and C, HIV-1 or HIV-2.
  • Any other medical condition that in the judgement of the investigator could interfere with their optimal participation in the study or produce a significant risk to the patient.
  • Patients that have participated in another study in the 30 days prior to this one or that have planned to participate simultaneously in another study.
  • Patients that have not given their informed consent to participate in this study.
  • Psychiatric disorder or other factors that in the judgement of the investigator could complicate the participation of the patient in the study.
  • Breast feeding, gestation or intention to become pregnant up to 6 months after finalising their participation in the study, or that are not using adequate methods of contraception during the same period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cellerix Sl

Tres Cantos, Madrid, 28760, Spain

Location

Related Publications (1)

  • 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: 12756590RESULT

MeSH Terms

Conditions

Rectal FistulaFistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Damian Garcia-Olmo, Prof.

    Cellerix

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 22, 2005

First Posted

June 23, 2005

Study Start

October 1, 2004

Study Completion

July 1, 2006

Last Updated

June 24, 2005

Record last verified: 2005-06

Locations

ES(1)