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

NCT00999115 | Completed Phase 1

• 2 other identifiers: EC08/00153EudraCT: 2009-010225-39
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectovaginal Fistula; Crohn Disease

Keywords

Rectovaginal Fistula; Crohn Disease; Allogenic; Adipose-Derived Stem Cells

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed

  12 weeks

Secondary Outcomes (4)

• Quality of life assessment using the SF-36 questionnaire

  12 weeks

• Adverse events

  1, 4, 8,12, 24, 54 weeks

• Clinically relevant variations in laboratory test

  1, 4 8, 12, 24, 54 weeks

• Quality of life assessment using the SF-36 questionnaire

  24 weeks

Study Arms (1)

Allogenic ASCs

EXPERIMENTAL

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.

Drug: Expanded allogenic adipose-derived adult stem cells

Interventions

Expanded allogenic adipose-derived adult stem cells DRUG

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.

Also known as: CX601 (company code)

Allogenic ASCs

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (5)

• 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.

  PMID: 12756590 BACKGROUND

• 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.

  PMID: 15933795 BACKGROUND

• 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.

  PMID: 18696086 BACKGROUND

• 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.

  PMID: 18694359 BACKGROUND

• 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.

  PMID: 27412883 DERIVED

MeSH Terms

Conditions

Rectovaginal Fistula; Crohn Disease

Condition Hierarchy (Ancestors)

Rectal Fistula; Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Vaginal Fistula; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammatory Bowel Diseases; Gastroenteritis

Study Officials

• Damián García Olmo, MD

  General Surgery Department, Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 20, 2009
• First Posted: October 21, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: January 26, 2012

Record last verified: 2012-01

Locations

ES (1)