Angiographic Delivery of AD-MSC for Ulcerative Colitis (NCT04312113) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Angiographic Delivery of AD-MSC for Ulcerative Colitis
United States20 participantsStarted 2020-11-16
Plain-language summary
Researchers are trying to determine the safety and feasibility of using an adipose derived mesenchymal stem cell (MSC) to treat people with Ulcerative Colitis.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and Females 18-65 years of age.
* Moderate to Severe medically refractory inflammatory ulcerative colitis:
* as defined by a an Adapted Mayo Score of 5to 9 points
* including an endoscopic sub-score of 2 or 3
* 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
* Current standard therapy includes 5-ASA products, thiopurines, anti-TNF therapy, ustekinemab, vedolizumab, and tofacitinib (i.e. all FDA approved therapies for UC).
* Refractory and failure to response is defined as continued symptoms despite 12 weeks of therapy at FDA approved doses by product necessitating change in medical strategy or referral for colectomy.
* 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:
* Inability to give informed consent.
* Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active a…
What they're measuring
1
Number of participants with treatment-related adverse events