None listed
Conditions
Brief summary
Apart from topical aminosalicylates and steroids, there is limited local treatment available for ulcerative proctitis, a incurable relapsing inflammatory condition of the bowel. This study aims to assess the safety of using locally injected stem cells derived from healthy placentas to treat ulcerative proctitis. Participants will receive a single injection of cells during routine colonoscopy and undergo assessment using routine colonoscopy, blood tests and stool tests. We hypothesise that these placental-derived stem cells will be safe and well-tolerated and that local injection is feasible.
Interventions
This intervention requires a single procedure of allogeneic human amnion epithelial cells (hAEC) obtained from the placentas of consenting healthy donors delivering at-term healthy babies at Monash Health, obtained under Good Manufacturing Practice-like conditions for clinical trial use. 20 million to 60 million cells will be administered per patient in 4-12 injections into the rectum (based on the baseline length of disease) during colonoscopy by a specialist gastroenterologist in our endoscopy
This intervention requires a single procedure of allogeneic human amnion epithelial cells (hAEC) obtained from the placentas of consenting healthy donors delivering at-term healthy babies at Monash Health, obtained under Good Manufacturing Practice-like conditions for clinical trial use. 20 million to 60 million cells will be administered per patient in 4-12 injections into the rectum (based on the baseline length of disease) during colonoscopy by a specialist gastroenterologist in our endoscopy suite at our quaternary Australian hospital. The overall estimated duration of injection will be approximately 30 minutes. The anaesthesia administered will be deep sedation as per routine general colonoscopy. The entire endoscopic procedure will be recorded and read by the endoscopist and a central reader as well as recorded in a procedural report.
Sponsors
Monash Health
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Adult participant 2. Ulcerative proctitis defined by less than 15 cm length of active inflammation from anus 3. At least 6 months disease duration 4. Refractory to at least one of the following treatments: topical aminosalicylate or prednisolone or budesonide. Definition of lack of response will assessed as per Modified Mayo Score of 5 or more, endoscopic subscore of 2 or more.
Exclusion criteria
1. Acute severe ulcerative colitis 2. Rectal or anal stenosis 3. Diverting stomas 4. Perianal or rectovaginal fistula 5. Active infection 6. Any previous colonic dysplasia or malignancy 7. Inability to tolerate or comply with trial requirements eg. high anaesthetic risk unsuitable for endoscopy 8. Current pregnancy/breast feeding
Outcome results
None listed