Stem Cell Therapy for Ulcerative Colitis

Overseen By Jessica Friton

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must be taking: 5-ASA, Thiopurines, Anti-TNF, others

Must not be taking: Investigational drugs

Disqualifiers: Cancer, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial allows participants to continue taking certain medications like corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, and anti-integrin therapy. However, if you are on an investigational drug, you must stop it at least 30 days before starting the trial.

What data supports the effectiveness of the treatment Adipose derived, autologous mesenchymal stem cells for Ulcerative Colitis?

Research shows that adipose-derived mesenchymal stem cells (MSCs) can help control inflammation in conditions like colitis by regulating immune responses and promoting tissue repair. However, MSCs from patients with ulcerative colitis may have reduced effectiveness compared to those from healthy donors. ^{1 2 3 4 5}

Is stem cell therapy safe for treating ulcerative colitis?

Research shows that using mesenchymal stem cells (from sources like human umbilical cords) for ulcerative colitis is generally safe, with no significant adverse reactions or long-term side effects reported in clinical trials. ^{1 6 7 8 9}

How is stem cell therapy different from other treatments for ulcerative colitis?

Stem cell therapy for ulcerative colitis is unique because it uses adipose-derived mesenchymal stem cells, which have the ability to modulate the immune system and promote tissue repair. Unlike traditional treatments that mainly focus on reducing inflammation, this therapy aims to repair the intestinal lining and restore immune balance, potentially offering a novel approach to managing the condition. ^{1 5 10 11 12}

Research Team

William Faubion, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for men and women aged 18-65 with moderate to severe ulcerative colitis that hasn't improved after trying at least two FDA-approved treatments. Participants must have a stable hemoglobin level, normal blood clotting, and agree to use contraception. Excluded are those with certain medical conditions like vasculitis, cancer history (except localized skin cancers), recent investigational drug use, partial colectomy, or significant allergies.

Inclusion Criteria

Ability to comply with protocol

I am between 18 and 65 years old.

I have tried at least 2 standard treatments for UC without success.

Exclusion Criteria

Pregnant patients or trying to become pregnant or breastfeeding

Inability to give informed consent

I have had a C. Diff infection in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-arterial delivery of 15 million or 30 million adipose-derived mesenchymal stem cells

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits on Day 1, Week 1, Week 2, Week 8, Week 24, Week 52, and Week 104

Treatment Details

Interventions

• Adipose derived, autologous mesenchymal stem cells

Trial Overview The study is testing the safety and effectiveness of using adipose-derived mesenchymal stem cells (cells from one's own body fat) in treating ulcerative colitis. Researchers will deliver these cells through an angiographic procedure to see if they can help heal ulcers in the colon.

Participant Groups

Group I: Autologous mesenchymal stem cells Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Endoscopic submucosal injection of adipose-derived mesenchymal stem cells ameliorates TNBS-induced colitis in rats and prevents stenosis. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Isolation of stem cell populations with trophic and immunoregulatory functions from human intestinal tissues: potential for cell therapy in inflammatory bowel disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A single administration of human adipose tissue-derived mesenchymal stromal cells (MSC) induces durable and sustained long-term regulation of inflammatory response in experimental colitis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

The role of adipose stem cells in inflammatory bowel disease: From biology to novel therapeutic strategies. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Adipose-Derived Stem Cells From Patients With Ulcerative Colitis Exhibit Impaired Immunosuppressive Function. [2022]

6. Greece pubmed.ncbi.nlm.nih.gov

Safety and therapeutic effect of mesenchymal stem cell infusion on moderate to severe ulcerative colitis. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Adipose-derived stem cells on the healing of ischemic colitis: a therapeutic effect by angiogenesis. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Human umbilical cord mesenchymal stem cells alleviate inflammatory bowel disease through the regulation of 15-LOX-1 in macrophages. [2018]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Safety of mesenchymal stromal cell therapy for inflammatory bowel diseases: results of a 5-year follow-up]. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Subcutaneous adipose tissue-derived stem cells facilitate colonic mucosal recovery from 2,4,6-trinitrobenzene sulfonic acid (TNBS)-induced colitis in rats. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Hypoxic ASCs-derived Exosomes Attenuate Colitis by Regulating Macrophage Polarization via miR-216a-5p/HMGB1 Axis. [2023]

12. China pubmed.ncbi.nlm.nih.gov

[Experimental study of adipose-derived mesenchymal stem cells in the treatment of Crohn's disease]. [2018]