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Angiographic Delivery of AD-MSC for Ulcerative Colitis | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Angiographic Delivery of AD-MSC for Ulcerative Colitis

A Phase I Single Site Open Label Study of Intra-arterial Delivery of Mesenchymal Stem Cells for Luminal Ulcerative Colitis

NCT04312113•Mayo Clinic

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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.
+6 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

November 16, 2020

Primary Completion Date

October 1, 2026

Completion Date

December 1, 2026

Last Updated

January 21, 2026

Enrollment

ESTIMATED participants

Conditions

Ulcerative Colitis

Interventions

Adipose derived, autologous mesenchymal stem cells

DRUG

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

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RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722

Ulcerative Colitis

View study

RECRUITINGPHASE3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Angiographic Delivery of AD-MSC for Ulcerative Colitis

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects