Angiographic Delivery of AD-MSC for Ulcerative Colitis

NCT04312113 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 19-000826
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Number of participants with mucosal healing

  6 months

• Number of participants with clinical symptom response

  24 months

• Number of participants with improved healing on pathology

  24 months

Study Arms (1)

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.

Drug: Adipose derived, autologous mesenchymal stem cells

Interventions

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.

Also known as: AD-MSC

Autologous mesenchymal stem cells

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• William Faubion, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2020
• First Posted: March 18, 2020
• Study Start: November 16, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)