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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Anal Fistula

Keywords

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ASCs (adult stem cells derived from adipose tissue) Fistula Cell Therapy Complex perianal fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Non-surgical autologous implant of ASCs

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Damian Garcia-Olmo, Prof.

Role: PRINCIPAL_INVESTIGATOR

Cellerix

Locations

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Cellerix Sl

Tres Cantos, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT

PMID: 12756590 (View on PubMed)

Other Identifiers

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Nr. 04-0211

Identifier Type: -

Identifier Source: secondary_id

GX401/TCFIS