Phase III trial results show efficacy of this investigational therapy up to 52 weeks.
In an industry-funded, randomized, controlled trial of a single stem cell injection for complex perianal fistulae in patients with Crohn disease, efficacy was shown at 24 weeks after treatment initiation. Now, investigators for that trial have analyzed outcomes at 1 year.
The study comprised 212 patients with a maximum of two internal and three external openings that were refractory to antibiotics, immunomodulatory drugs, or anti–tumor necrosis factor agents. Patients with rectovaginal fistulas, lumen stenosis, active proctitis, an abscess >2 cm, a diverting stoma, or prior surgery were excluded.
At least two weeks before injection, patients underwent baseline magnetic resonance imaging (MRI), examination under anesthesia, and seton placement…
Reviewing Author
DisclosuresConsultant/Advisory BoardOlympus Corporation America; Boston Scientific
Speaker’s BureauOlympus
Grant/Research SupportMedtronic; Boston Scientific; Colonary Solutions; Paion Medical; Medivators; Braintree Laboratories
Editorial BoardsWorld Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology; GI Journal Watch; Austin Journal of Gastroenterology; World Journal of Gastrointestinal Pharmacology & Therapeutics
Leadership Positions in Professional SocietiesAmerican Society for Gastrointestinal Endoscopy (Treasurer); US Multi-Society Task Force (AGA, ACG, ASGE) (Chair)
DisclosuresConsultant/Advisory BoardOlympus Corporation America; Boston Scientific
Speaker’s BureauOlympus
Grant/Research SupportMedtronic; Boston Scientific; Colonary Solutions; Paion Medical; Medivators; Braintree Laboratories
Editorial BoardsWorld Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology; GI Journal Watch; Austin Journal of Gastroenterology; World Journal of Gastrointestinal Pharmacology & Therapeutics
Leadership Positions in Professional SocietiesAmerican Society for Gastrointestinal Endoscopy (Treasurer); US Multi-Society Task Force (AGA, ACG, ASGE) (Chair)