Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA) (ALOREVA)
Primary Purpose
Rectovaginal Fistula, Crohn Disease
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Expanded allogenic adipose-derived adult stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Rectovaginal Fistula focused on measuring Rectovaginal Fistula, Crohn Disease, Allogenic, Adipose-Derived Stem Cells
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario La Paz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allogenic ASCs
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed
Secondary Outcome Measures
Quality of life assessment using the SF-36 questionnaire
Adverse events
Clinically relevant variations in laboratory test
Quality of life assessment using the SF-36 questionnaire
Full Information
NCT ID
NCT00999115
First Posted
October 20, 2009
Last Updated
January 25, 2012
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
1. Study Identification
Unique Protocol Identification Number
NCT00999115
Brief Title
Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)
Acronym
ALOREVA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectovaginal Fistula, Crohn Disease
Keywords
Rectovaginal Fistula, Crohn Disease, Allogenic, Adipose-Derived Stem Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allogenic ASCs
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Expanded allogenic adipose-derived adult stem cells
Other Intervention Name(s)
CX601 (company code)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Quality of life assessment using the SF-36 questionnaire
Time Frame
12 weeks
Title
Adverse events
Time Frame
1, 4, 8,12, 24, 54 weeks
Title
Clinically relevant variations in laboratory test
Time Frame
1, 4 8, 12, 24, 54 weeks
Title
Quality of life assessment using the SF-36 questionnaire
Time Frame
24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damián García Olmo, MD
Organizational Affiliation
General Surgery Department, Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
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
background
PubMed Identifier
15933795
Citation
Garcia-Olmo D, Garcia-Arranz M, Herreros D, Pascual I, Peiro C, Rodriguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. doi: 10.1007/s10350-005-0052-6.
Results Reference
background
PubMed Identifier
18696086
Citation
Garcia-Olmo D, Herreros D, Pascual M, Pascual I, De-La-Quintana P, Trebol J, Garcia-Arranz M. Treatment of enterocutaneous fistula in Crohn's Disease with adipose-derived stem cells: a comparison of protocols with and without cell expansion. Int J Colorectal Dis. 2009 Jan;24(1):27-30. doi: 10.1007/s00384-008-0559-0. Epub 2008 Aug 12.
Results Reference
background
PubMed Identifier
18694359
Citation
Garcia-Olmo D, Garcia-Arranz M, Herreros D. Expanded adipose-derived stem cells for the treatment of complex perianal fistula including Crohn's disease. Expert Opin Biol Ther. 2008 Sep;8(9):1417-23. doi: 10.1517/14712598.8.9.1417.
Results Reference
background
PubMed Identifier
27412883
Citation
Garcia-Arranz M, Herreros MD, Gonzalez-Gomez C, de la Quintana P, Guadalajara H, Georgiev-Hristov T, Trebol J, Garcia-Olmo D. Treatment of Crohn's-Related Rectovaginal Fistula With Allogeneic Expanded-Adipose Derived Stem Cells: A Phase I-IIa Clinical Trial. Stem Cells Transl Med. 2016 Nov;5(11):1441-1446. doi: 10.5966/sctm.2015-0356. Epub 2016 Jul 13.
Results Reference
derived
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Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)
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