Angiographic Delivery of AD-MSC for Ulcerative Colitis

Study Purpose

Researchers are trying to determine the safety and feasibility of using an adipose derived mesenchymal stem cell (MSC) to treat people with Ulcerative Colitis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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 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.
Note that auto-immmunity is defined as a systemic immune mediated disease for which the antigen is known or unknown. Autoimmune diseases other than UC are excluded. Extraintestinal manifestations of UC (specifically joint inflammation, eye inflammation, PSC, skin manifestations- i.e. pyoderma gangrenosum, erythema nodosum) will be allowable.
  • - Allergic to local anesthetics - Pregnant patients or trying to become pregnant or breast feeding.
  • - Neoplasia of the colon and preoperative biopsy - C.
Difficile infection within 30 days of study injection
  • - 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.

Trial Details

Trial ID:

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.

NCT04312113
Phase

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.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

William Faubion, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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.

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

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