A Phase 1/2 interventional study of Allogeneic adipose tissue-derived mesenchymal stem cells in Ulcerative Colitis, sponsored by Instituto de Investigación Hospital Universitario La Paz. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-02.
Sponsored by Instituto de Investigación Hospital Universitario La Paz · Phase 1/2, Interventional, and Treatment
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, assessing the absence of adverse events associated to the investigational drug, and to evaluate the efficacy of the treatment to induce remission of moderate active ulcerative colitis, by improvements in disease activity index, quality of life index, and endoscopic index.
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 number of clinical trials are being conducted worldwide testing th efficacy of MSC, mainly isolated from bone marrow, for different conditions, such as Graft Versus host Disease, refractory Crohn's Disease, ischemic stroke, acute myocardial infarction, type I Diabetes Mellitus, or Chronic Obstructive Pulmonary Disease. Usually, the route of administration of the cells in these studies is intravenous. Local injection of MSC for fistulizing Crohn's Disease has proven efficacious. Endoscopy is a routinary technique for the evaluation of gastrointestinal and colonic conditions. The purpose of our study is to evaluate safety and efficacy of the intracolonic injection by using a colonoscope of allogeneic adipose tissue-derived MSC in patients with moderate active ulcerative colitis.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's planned enrollment of 8 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 100 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Treatment consists in a cell suspension (5 million cells/mL) in aseptic buffered solution containing human expanded adipose-derived stem cells (eASCs) of allogeneic origin in disposable vials with no preservative agents. The cells will be given in different sites within the affected colonic submucosa at a total dose of 60 million cells with the use of a colonoscope.
Drug: Allogeneic adipose tissue-derived mesenchymal stem cells
The cells will be given in different sites within the affected colonic submucosa at a total dose of 60 million cells with the use of a colonoscope.
Also known as: Cx-601 (company code)
Safety
Evaluation of the presence of any event that could be considered adverse event, especially if it can be attributed to the investigational drug. Physical exam, vital signs, and laboratory tests (hemogram, biochemistry, coagulation, and cytokines) will be performed at 0, 9-10 days, and 4, 8, and 12 weeks.
Time frame: Up to 12 weeks
Efficacy: Change from Baseline in Modified Truelove-Witts score
Remission will be considered if it descends below 11, and response if it diminishes at least 30%. Modified Truelove-Witts score will be evaluated at 0, 4, 8, and 12 weeks.
Time frame: Up to 12 weeks
Efficacy: Change from Baseline in Quality of Life index, Inflammatory Bowel Disease Questionnaire (IBDQ-32)
Response will be considered if it improves at least 30%. IBDQ-32 will be evaluated at 0, 4, 8, and 12 weeks.
Time frame: Up to 12 weeks
Efficacy: Change from baseline in Mayo endoscopic index.
Remission will be considered if reaches 0 points and response if the score diminishes. Endoscopy will be performed at 0 and 8 weeks.
Time frame: 8 weeks
Change from Baseline in C Reactive Protein
C Reactive Protein will be evaluated at 0, 9-10 days, and 4, 8, 12 weeks.
Time frame: Up to 12 weeks
Change from Baseline in fecal calprotectin
Fecal calprotectin will be evaluated at 0, 4, 8, and 12 weeks.
Time frame: Up to 12 weeks
This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Instituto de Investigación Hospital Universitario La Paz