Stem Cell Fistula Plug in Perianal Crohn's Disease (MSC-AFP)
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|ClinicalTrials.gov Identifier: NCT01915927|
Recruitment Status : Active, not recruiting
First Posted : August 5, 2013
Last Update Posted : November 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Perianal Crohn's Disease||Drug: MSC-AFP||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease.|
|Actual Study Start Date :||July 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Only 1 arm: treatment with MSC-AFP
- To determine the safety and toxicity of using autologous MSC coated fistula plug in patients with fistulizing Crohn's Disease. [ Time Frame: 2-24 months ]The primary endpoint of this study is to determine the safety and feasibility of using adipose derived, autologous mesenchymal stromal cells (MSC) bound to the Gore® Bio-A® Fistula Plug for treatment of refractory CD perianal fistulae.
- To assess in preliminary fashion the response of fistula healing induced by the GORE plug containing MSC [ Time Frame: 2-24 months ]To assess in preliminary fashion the response of fistula healing induced by the GORE plug containing MSC i) Clinically by drainage assessment and ii) Radiographically by MRI, the gold standard test for assessment of healing.
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): NCT01915927
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||William Faubion, MD||Mayo Clinic|