Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue

NCT01157650 | Completed Phase 1 DMC

• 2 other identifiers: CSM/CROH2009-009880-71
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

Primary outcome measure: Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study. Secondary outcome measures:

• Fistulas healing efficiency
• Changes in quality of life in patients treated
• Changes of systemic Crohn's disease after implant
• Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem Cells treatment success.
• Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with:
• Phenotype study
• Suppressor capacity study.
• Citoquines production analysis

Conditions

Crohn Disease

Keywords

Fistulizing Crohn's disease; stem cells implant

Outcome Measures

Primary Outcomes (1)

• Security and tolerance

  Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Chron's disease patients, collecting the reactions and adverse events occurred during the study

  3 years

Secondary Outcomes (1)

• therapeutic effect

  3 years

Study Arms (1)

Autologous mesenchymal stem cells

EXPERIMENTAL

Fistulizing Crohn's disease

Other: Autologous mesenchymal stem cells

Interventions

Autologous mesenchymal stem cells OTHER

The trial is divided in three phases: I. - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature. II.- Treatment phase includes: 1. Liposuction procedure to obtain adipose tissue. 2. Processing and production of Autologous Mesenchymal Stem Cells from adipose tissue (ASCs) 3. ASCs implant III.- Follow up: Study visits post-implant will take place at the 1st week (+/- 3 days), 4th week (+/- 3 days), 8th week (+/- 7 days), 12nd week (+/- 7 days), 24th week (+/- 7 days), and 1 year (+/- 7 days) after implant.

Also known as: Implant of ASCs.

Autologous mesenchymal stem cells

Eligibility Criteria

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

You may qualify if:

• Fistulizing Crohn´s disease patients with 1 or more enterocutaneous fistulas, recto-vaginal fistula or complex perianal fistula. The complex perianal fistula is defined as a fistula presenting one of these conditions:
• Trans-sphincteric, supra-sphincteric or extra-sphincteric tract, determined with:
• Clinical criteria: No palpation of the tract and surgical exploration
• Radiological criteria: Nucleal Magnetic Resonance (NMR)or Echoendoscopy
• Multiple fistulas
• "Horseshoe" fistula
• Any fistula with fecal incontinence associated
• Any fistula with a risk of fecal incontinence as a result of:
• previous anal fistula surgery or other perianal pathology (hemorrhoids, fissures), that involves lesions or muscular complications.
• Obstetric or iatrogenic sphincter lesions
• Patients with Crohn Disease (CD) at screening and been diagnosed within 12 months before acceptance of clinical, endoscopical, anatomopathological and/or radiological criteria and have a non-active CD.(Crohn´s Disease Activity Index (CDAI)≤ 200)
• \> 18 Years and both genders eligible.
• Negative pregnancy test In female fertile subjects
• Patient must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care.
• Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements

You may not qualify if:

• Patients with a highly active CD, i.e., if they meet any of the following criteria:
• Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease that requires immediate treatment, revealed by rectosigmoidoscopy
• CDAI ≥201
• Presence of abscess or other collections not drained (revealed by basal radiologic study).
• Presence of setons drainage, unless they are removed before treatment beginning.
• Rectal and/ or anal stenosis revealed with rectoscopy or EBA.
• Patients who have received infliximab or any other anti-TNF agent within 8 weeks before the cell treatment administration.
• Patients who have received tacrolimus or cyclosporine within 4 weeks before cell treatment.
• Severe uncontrolled diseases (chronic renal failure, cardio, pulmonary,…).
• Patients with diagnosis of malignant neoplasia, except basal cell or epidermoid carcinoma of the skin or previous history of malignant tumours, except those that have no evidence of relapse for at least 5 years.
• Subjects with congenital or acquired immunodeficiency.
• Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
• Patient had major surgery or serious traumatism within 6 weeks before enrolment.
• Pregnant or breast-feeding women.
• Physical or psychical impossibility of following the protocol requirements

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (3)

Clínica Universitaria de Navarra

Pamplona, Pamplona, 31008, Spain

Location

Hospital Provincial de Navarra

Pamplona, Pamplona, 31008, Spain

Location

Hospital Virgen del Camino

Pamplona, Pamplona, 31008, Spain

Location

Related Publications (21)

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  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.

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  PMID: 17560413 RESULT

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Felipe Prosper, MD, PhD

  Clinica Universidad de Navarra

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2010
• First Posted: July 7, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 8, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)