Angiographic Delivery of AD-MSC for Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT04312113|
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : September 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Adipose derived, autologous mesenchymal stem cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Single Site Open Label Study of Intra-arterial Delivery of Mesenchymal Stem Cells for Luminal Ulcerative Colitis|
|Actual Study Start Date :||November 16, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Autologous mesenchymal stem cells
Adipose derived, autologous mesenchymal stem cells (AD-MSCs) at a dose of 15 million or 30 million cells will be administered via intra-arterial delivery with interventional radiology to the inferior mesenteric artery in subjects with medically refractory ulcerative colitis.
Drug: Adipose derived, autologous mesenchymal stem cells
Fat tissue will be enzymatically treated and cells will be cultured until a sufficient number are obtained for the treatment protocol.
Other Name: AD-MSC
- Number of participants with treatment-related adverse events [ Time Frame: 24 months ]Evaluate safety by assessment of adverse events defined as worsening (change in nature, severity, or frequency of bowel movements, bleeding per rectum, or tenesmus) of UC present at the time of the study, intercurrent illnesses, abnormal laboratory values (this includes clinically significant shifts from baseline within the range of normal that the investigator considers to be clinically significant) or clinically significant abnormalities in physical examination, vital signs, weight, frequency of bloody stools or change in stools.
- Number of participants with mucosal healing [ Time Frame: 6 months ]Mucosal appearance at endoscopy via Adapted Mayo Score (defined as score of 0 or 1)
- Number of participants with clinical symptom response [ Time Frame: 24 months ]To assess the clinical symptom response of luminal healing induced by the intra-arterial delivery of autologous AD-MSCs for the treatment of UC. Using the validated via Adapted Mayo Score (decrease from Baseline ≥ 2 points and ≥ 30%, including a decrease in rectal bleeding sub-score ≥ 1 or an absolute rectal bleeding sub-score ≤ 1)
- Number of participants with improved healing on pathology [ Time Frame: 24 months ]Histopathology: Improved healing on surgical pathology (colectomy specimen or post-intervention colonic biopsies) as compared to pre-operative endoscopic biopsies
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): NCT04312113
|Contact: Jessica Friton||(507) email@example.com|
|Contact: Erin Kammerfirstname.lastname@example.org|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||William Faubion, MD||Mayo Clinic|