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

Primary Purpose

Anal Fistula

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Non-surgical autologous implant of ASCs
Sponsored by
Cellerix
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula focused on measuring ASCs (adult stem cells derived from adipose tissue), Fistula, Cell Therapy, Complex perianal fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cellerix Sl

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

No fistula recurrence after 1 year follow-up

Full Information

First Posted
June 22, 2005
Last Updated
June 23, 2005
Sponsor
Cellerix
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1. Study Identification

Unique Protocol Identification Number
NCT00115466
Brief Title
Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cellerix

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
Keywords
ASCs (adult stem cells derived from adipose tissue), Fistula, Cell Therapy, Complex perianal fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Non-surgical autologous implant of ASCs
Primary Outcome Measure Information:
Title
Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization)
Secondary Outcome Measure Information:
Title
No fistula recurrence after 1 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian Garcia-Olmo, Prof.
Organizational Affiliation
Cellerix
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cellerix Sl
City
Tres Cantos
State/Province
Madrid
ZIP/Postal Code
28760
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
12756590
Citation
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.
Results Reference
result

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

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