Ulcerative Colitis (UC) is a chronic inflammatory disease affecting the mucosal lining of the colon and rectum and the incidence is increasing, but the etiology remains unknown. Patients may require a proctocolectomy due to refractory disease. Prior to an operation, UC is treated with antibiotic therapy, immunomodulatory therapy and immunosuppressive agents. While there is an increasing number of approved biologics for the treatment of UC, there are many patients that still suffer from refractory disease. Thus, alternative mechanisms of therapy are desperately needed.
Treatments that have the potential to reduce mucosal inflammation could alleviate the pathology of luminal UC. This trial will use arterially delivered mesenchymal stem cells (MSCs) to produce these regenerative signals allowing for mucosal healing. This study will enroll patients with medically refractory moderate to severe inflammatory UC who are or plan to be scheduled for a colectomy. Patients enrolled will be those who failed all attempts at standard treatment including antibiotics, corticosteroids, immunomodulator, and/or biologic therapy.
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.