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Researchers are trying to determine the safety and feasibility of using an adipose derived mesenchymal stem cell (MSC) to treat people with Ulcerative Colitis.
Participants will undergo screening for study, if eligible, participants will be dosed with 15 million or 30 million cells will be administered via IA delivery with interventional radiology. Participant study visits after study intervention includes visits on: Day 1, Week 1, Week 2, Week 8, Week 24, Week 52, and Week 104.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous mesenchymal stem cells | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipose derived, autologous mesenchymal stem cells | Drug | Fat tissue will be enzymatically treated and cells will be cultured until a sufficient number are obtained for the treatment protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with mucosal healing | Mucosal appearance at endoscopy via Adapted Mayo Score (defined as score of 0 or 1) | 6 months |
| Number of participants with clinical symptom response |
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Inclusion Criteria:
Males and Females 18-65 years of age.
Moderate to Severe medically refractory inflammatory ulcerative colitis:
Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, and anti-integrin therapy are permitted.
To meet the definition of refractory UC, all patients must have failed at least 2 standard FDA approved medications for the treatment of UC
All patients should have undergone a colonoscopy in last 12 months to rule out malignant or premalignant condition
Female subjects that are of child bearing potential must to agree to use effective contraception method(s) for the duration of the study
Hemoglobin must be greater than 8
INR must be less than 1.5
Ability to comply with protocol
Competent and able to provide written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Faubion, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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)
| 24 months |
| Number of participants with improved healing on pathology | Histopathology: Improved healing on surgical pathology (colectomy specimen or post-intervention colonic biopsies) as compared to pre-operative endoscopic biopsies | 24 months |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |