Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn`s Disease (ALOREVA)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

ClinicalTrials.gov Identifier:

NCT00999115

First received: October 20, 2009

Last updated: January 25, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 20, 2009

Last Updated Date

January 25, 2012

Start Date ^ICMJE

September 2009

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00999115 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of life assessment using the SF-36 questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 1, 4, 8,12, 24, 54 weeks ] [ Designated as safety issue: Yes ]
Clinically relevant variations in laboratory test [ Time Frame: 1, 4 8, 12, 24, 54 weeks ] [ Designated as safety issue: Yes ]
Quality of life assessment using the SF-36 questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn`s Disease (ALOREVA)

Official Title ^ICMJE

Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in Crohn´s Disease

Brief Summary

The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Rectovaginal Fistula
Crohn Disease

Intervention ^ICMJE

Drug: Expanded allogenic adipose-derived adult stem cells

Administration will be preceded by localization and closure of the internal opening. Cell treatment injection will be performed following Major Ambulatory Surgery standards. Patients will receive an intralesional dose of 20 million cells at baseline. 50% of the cell suspension will be placed into fistula walls of the internal opening, with the remaining 50% being injected across the wall tracts of the target fistula. Patients without healing (complete fistula closure)at week 12 will receive a second dose of 40 million cells, using the same treatment approach.

Other Name: CX601 (company code)

Study Arm (s)

Experimental: Allogenic ASCs

Intralesional dose of 20 million cells at baseline with a possible second administration of 40 million in case of incomplete fistula closure following week 12 assessment.

Intervention: Drug: Expanded allogenic adipose-derived adult stem cells

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2011

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Signed informed consent.
Patients with Crohn´s disease diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomopathological and/or radiologic criteria.
Fulfilling one of the following criteria:
- At least, one previous surgery for fistulous disease.
- Physical status which discourage liposuction.
Rectovaginal fistula.
Women of a childbearing age. Good general state of health according to the findings of the clinical history and the physical examination.

Exclusion Criteria:

Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease requiring immediate therapy, assessed by rectosigmoidoscopy
Patients with CDAI≥201
Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
Patients who have received infliximab or any other anti TNF agent in the 8 weeks before the cell treatment administration
Patients who have received tacrolimus or cyclosporine in the 4 weeks before the cell treatment administration
Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent.
Patients allergic to local anesthetics or gadolinium (MRI contrast) MRI is unfeasible (e.g. due to the presence of pacemakers, hip replacements or severe claustrophobia)
Patients who have suffering major surgery or severe trauma in the prior 6 months
Pregnant or breastfeeding women
Patients currently receiving, or having received within 1 month prior to enrolment into this clinical trial, any investigational drug.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00999115

Other Study ID Numbers ^ICMJE

EC08/00153, EudraCT: 2009-010225-39

Has Data Monitoring Committee

Responsible Party

Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Study Sponsor ^ICMJE

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Damián García Olmo, MD

General Surgery Department, Hospital Universitario La Paz

Information Provided By

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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