Overview

Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease

Status:
Terminated
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine safety and efficacy of eASCs (expanded adult stem cells) for treatment of complex perianal fistulas in patients with Crohn's disease.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cellerix
Tigenix S.A.U.
Treatments:
Polystyrene sulfonic acid
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

- Presence of complex perianal fistula with 3 or fewer fistulous tracts assessed by MRI

- Patients with persistent and active complex perianal fistula and non-active luminal
Crohn's disease defined by a CDAI ≤ 200. (Complex perianal fistula is defined as a
fistula that meets one or more of the following criteria: High fistulas [high
inter-sphincteric, high trans-sphincteric, extra-sphincteric or supra-sphincteric],
presence of 3 or fewer external openings [tracts] associated with a complex perianal
fistula, or pain/fluctuation

- Good general state of health according to the findings of the clinical history and the
physical examination

- Women of a childbearing age with negative serum or urine pregnancy test (sensitive to
25 IU hCG). Both men and women should use appropriate birth control methods defined by
the investigator

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 a 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

- The presence of setons unless removed prior to the study procedure

- Presence of >3 fistulous tracts and/or external openings

- Patients with rectal and/or anal stenosis evaluated by rectoscopy or EUA

- 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 rectovaginal fistula, anal fistula(s), and/or non-perianal
enterocutaneous fistula

- Patients with HIV, HBV, HCV or treponema infection, whether active or latent

- 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 the opinion of the investigator, is
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 the study

- Patients with congenital or acquired immunodeficiencies

- Patients with abnormal laboratory test findings that contraindicate their inclusion in
the study

- 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)

- Liposuction with extraction of at least 100 cm3 of fat from the abdominal wall is
technically unfeasible or the patient does not consent to the procedure

- Patients in need of surgery in the perianal region for reasons other than fistulas at
the time of inclusion in the study, or a need for such surgery is foreseen in this
region in the 26 weeks after treatment administration.

- Patients who have suffered major surgery or severe trauma in the prior 6 months

- Pregnant or breastfeeding women

- Patients who do not wish to or cannot comply with study procedures

- Patients currently receiving, or having received within 1 month prior to enrolment
into this clinical trial, any investigational drug

- Patients unlikely to comply with study procedures