Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01372969 |
Date of registration:
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30/08/2010 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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.
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Scientific title:
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Multicenter Phase I/IIa 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. |
Date of first enrolment:
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June 2009 |
Target sample size:
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24 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01372969 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Spain
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Contacts
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Name:
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Damián García Olmo, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Hospital La Paz |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
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
- 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 a history of abuse of alcohol or other addictive substances in the 6
months prior to inclusion.
- 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 any type of medical or psychiatric disease which, in the opinion of the
investigator, could be grounds for exclusion from the study.
- Subjects with congenital or acquired immunodeficiencies.
- Subjects with abnormal laboratory test findings that contraindicate their inclusion in
the study.
- Subjects allergic to anesthetics or MRI contrast.
- MRI is unfeasible, (e.g. due to the presence of pacemakers, hip replacements or severe
claustrophobia)
- Subjects 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.
- Subjects who have suffered major surgery or severe trauma in the prior 6 months.
- Pregnant or breastfeeding women. (Both men and women should use appropriate birth
control methods defined by the investigator).
- Subjects currently receiving, or having received within 1 month prior to enrolment
into this clinical trial, any investigational drug.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anal Fistula
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Crohn's Disease
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Intervention(s)
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Drug: Cx601
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Primary Outcome(s)
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Incidence of treatment emergent adverse-events
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Percentage of subjects in whom, the external openings of treated perianal fistula have closed.
[Time Frame: week 12]
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Percentage of subjects with MRI fistula healing (absence of collections >2cm)
[Time Frame: weeks 12 and 24]
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The reduction in the number of draining fistulas
[Time Frame: weeks 10,12, 22 and 24]
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Percentage of subjects presenting luminal relapse
[Time Frame: weeks 12 and 24.]
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The increase in the number of closed fistulas.
[Time Frame: weeks 12 and 24]
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Secondary ID(s)
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Cx601-0101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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