Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.

NCT01372969 | Completed Phase 1

• 1 other identifier: Cx601-0101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to asses the safety and efficacy of adipose-derived adult stem cells from healthy donnors for treatment of complex perianal fistulas in Crohn's disease.

Conditions

Crohn's Disease; Anal Fistula

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse-events

  24 weeks

Secondary Outcomes (5)

• The reduction in the number of draining fistulas

  weeks 10,12, 22 and 24

• The increase in the number of closed fistulas.

  weeks 12 and 24

• Percentage of subjects in whom, the external openings of treated perianal fistula have closed.

  week 12

• Percentage of subjects with MRI fistula healing (absence of collections >2cm)

  weeks 12 and 24

• Percentage of subjects presenting luminal relapse

  weeks 12 and 24.

Study Arms (1)

Cx601

EXPERIMENTAL

Drug: Cx601

Interventions

Cx601 DRUG

Suspension of adult expanded allogenic adipose-derived stem cells (eASCs) at a doses of 20 million cells and 40 million cells.

Cx601

Eligibility Criteria

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

You may qualify if:

• Signed informed consent.
• Subjects with Crohn's disease diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomopathological and/or radiologic criteria.
• Presence of complex perianal fistula with 3 or fewer fistulous tracts assessed by MRI,
• Subjects with persistent and active complex perianal fistula and non active luminal CD defined by a CDAI ≤ 200.
• Subjects of either sex aged over 18 years. 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
• Subjects with a CDAI ≥ 221.
• Subjects 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).
• The presence of setons unless removed prior to treatment start.
• Presence of \>3 fistulous tracts and/or external openings.
• Subjects with rectal and/or anal stenosis evaluated by rectoscopy or EUA.
• Subjects who have received infliximab or any other anti-TNF agent in the 8 weeks before the cell treatment administration.
• Subjects who have received tracrolimus or ciclosporine in the 4 weeks before the cell treatment administration.
• Subjects with rectovaginal fistula, anal fistula(s), and/or non-perianal enterocutaneous fistula.
• Subjects with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or Subjects with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years.
• Subjects with cardiopulmonary disease which, in the opinion of the investigator, is unstable or sufficiently serious to exclude the patient from the study.
• Subjects with congenital or acquired immunodeficiencies.
• Subjects allergic to anesthetics or MRI contrast.
• MRI is unfeasible, (e.g. due to the presence of pacemakers, hip replacements or severe claustrophobia)
• Subjects who have suffered major surgery or severe trauma in the prior 6 months.

Sponsors & Collaborators

• Tigenix S.A.U.: lead

Study Sites (6)

Hospital Son Dureta

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital San Juan de Dios del Aljarafe

Bormujos, Sevilla, 41930, Spain

Location

Hospital Juan Ramón Jimenez

Huelva, 21005, Spain

Location

Hospital Universitario La Paz

Madrid, 28042, Spain

Location

Hospital Universitario Nuestra Señora de Valme

Seville, 41014, Spain

Location

Hospital Virgen de la Macarena

Seville, 41071, Spain

Location

MeSH Terms

Conditions

Crohn Disease; Rectal Fistula

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Intestinal Fistula; Digestive System Fistula; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Damián García Olmo, MD

  Hospital La Paz

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: June 14, 2011
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

ES (6)