Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative Colitis (ALOASCU)
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|ClinicalTrials.gov Identifier: NCT01914887|
Recruitment Status : Unknown
Verified July 2013 by Instituto de Investigación Hospital Universitario La Paz.
Recruitment status was: Recruiting
First Posted : August 2, 2013
Last Update Posted : August 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Allogeneic adipose tissue-derived mesenchymal stem cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIa Clinical Trial to Evaluate Safety and Efficacy of Adipose Tissue-derived Mesenchymal Stem Cells (ASC) on Induction to Remission in Ulcerative Colitis|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: allogeneic ASCs
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.
Other Name: Cx-601 (company code)
- Safety [ Time Frame: Up to 12 weeks ]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.
- Efficacy: Change from Baseline in Modified Truelove-Witts score [ Time Frame: Up to 12 weeks ]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.
- Efficacy: Change from Baseline in Quality of Life index, Inflammatory Bowel Disease Questionnaire (IBDQ-32) [ Time Frame: Up to 12 weeks ]Response will be considered if it improves at least 30%. IBDQ-32 will be evaluated at 0, 4, 8, and 12 weeks.
- Efficacy: Change from baseline in Mayo endoscopic index. [ Time Frame: 8 weeks ]Remission will be considered if reaches 0 points and response if the score diminishes. Endoscopy will be performed at 0 and 8 weeks.
- Change from Baseline in C Reactive Protein [ Time Frame: Up to 12 weeks ]C Reactive Protein will be evaluated at 0, 9-10 days, and 4, 8, 12 weeks.
- Change from Baseline in fecal calprotectin [ Time Frame: Up to 12 weeks ]Fecal calprotectin will be evaluated at 0, 4, 8, and 12 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914887
|Contact: Maria Dolores Martin Arranz, MD||+34 firstname.lastname@example.org|
|Contact: Fernando de Miguel, PhD||+34 email@example.com|
|Hospital Universitario La Paz||Recruiting|
|Madrid, Spain, 28046|
|Contact: Maria Dolores Martin Arranz, MD +34 917277467 firstname.lastname@example.org|
|Contact: Fernando de Miguel, PhD +34 917277389 email@example.com|
|Principal Investigator: Maria Dolores Martin Arranz, MD|
|Principal Investigator:||Maria Dolores Martin Arranz, MD||Gastroenterology Department|