Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 65 Years|
- - 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 angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
- - Specific exclusions; Known history of hepatitis B, C, or HIV - Patients that have had a partial colectomy - Patients that have underlying vasculitis or have been diagnosed with an underlying condition that predisposes to developing blood clots.
- - History of cancer including melanoma (with the exception of localized skin cancers) - Investigational drug within thirty (30) days of baseline - History of clinically significant auto-immunity (other than UC) or any previous example of fat-directed autoimmunity.
- - Allergic to local anesthetics - Pregnant patients or trying to become pregnant or breast feeding.
- - Neoplasia of the colon and preoperative biopsy - C.
- - Diagnosis of indeterminate colitis or suspicion of CD - Subjects with fulminant colitis, toxic megacolon, with ostomy, or ileoanal pouch - History or demonstration of pathology related to adipose tissue - Any other indication determined by the PI to be counter indicated for participation on this trial.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|William Faubion, MD|
|Principal Investigator Affiliation||Mayo Clinic|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
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.
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.