Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula

Anal Fistula Clinical Trial

Official title:

Phase II Clinical Trial, Multicentre, Randomised and Comparative, to Evaluate the Efficacy and Safety of a New Therapy With Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00115466
• Other study ID #: GX401/TCFIS
• Secondary ID: Nr. 04-0211
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 22, 2005
• Last updated: June 23, 2005
• Start date: October 2004
• Est. completion date: July 2006

Study information

• Verified date: June 2005
• Source: Cellerix
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Description:

Comparative, multicentre, randomised clinical trial, 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. The closure/healing of the fistula will be evaluated periodically, and it will be considered completely closed if there is no suppuration from the external orifice and re-epithelialisation can be observed at 8 weeks after the administration of the randomised therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 a diagnosis of active Tuberculosis at the moment of inclusion.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Fistula
• Fistula

Intervention

Procedure:
• Non-surgical autologous implant of ASCs

Locations

Country	Name	City	State
Spain	Cellerix Sl	Tres Cantos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Cellerix

Country where clinical trial is conducted

Spain, 

References & Publications (1)

García-Olmo D, García-Arranz M, García LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, García-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization)
Secondary	No fistula recurrence after 1 year follow-up