Status:
UNKNOWN
Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative Colitis
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsors:
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Ministry of Health, Spain
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The aims of our study are to evaluate the feasibility and safety of endoscopic injection of adipose tissue-derived mesenchymal stem cells in human subjects with moderate active ulcerative colitis, ass...
Detailed Description
Mesenchymal stem cells (MSC) may be a therapeutic option in diseases associated with severe inflammation or auto-immune diseases, due to their immunomodulatory and anti-inflammatory properties. A numb...
Eligibility Criteria
Inclusion
- Patients of either sex aged 18 years and older
- Signed informed consent
- Patients with ulcerative colitis diagnosed at least 6 months earlier in accordance with usual criteria
- Left-sided colitis with moderate activity defined by a modified Truelove-Witts score between 11 and 21, and with no response to 4 weeks of treatment with oral and/or topical 5-aminosalicylates
- Negative pregnancy test for women of childbearing potential (from menarche to menopause) using consistently and correctly highly effective (i.e. less than 1% failure rate per year) methods of birth control
Exclusion
- Mental disability that impedes adequate understanding of the study and of the associated procedures
- Extensive colitis
- Patients with an impaired general state which requires, according to the investigator judgment, immediate treatment with corticosteroids and/or anti-Tumor Necrosis Factor (TNF) and/or surgery
- Patients that fulfill criteria of corticodependency and in ongoing treatment with corticosteroids
- Patients with previous colectomies
- Known history of alcohol or other addictive substances abuse
- History of malignant disease - Patients having participated in clinical trials with any investigational drug within 6 months prior to enrolment in this study
- Patients with known allergies to penicillin, gentamicin, aminoglycosides, human serum albumin (HSA), Dulbecco's modified Eagle medium (DMEM), or materials of bovine origin
- Pregnant or breastfeeding women
- Presence of severe concomitant diseases
- Patients with suspicion of Crohn?s enterocolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, or microscopic colitis
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01914887
Start Date
June 1 2013
End Date
December 1 2013
Last Update
August 2 2013
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Spain, 28046