Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells for the Treatment of Refractory Proctitis in Ulcerative Colitis - BMMSCproctitis

eiden University Medical Center0 sites14 target enrollmentFebruary 19, 2018

Conditionslcerative Colitis MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856 Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: lcerative Colitis
Sponsor: eiden University Medical Center
Enrollment: 14
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 19, 2018

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

eiden University Medical Center

Eligibility Criteria

Inclusion Criteria

•a)Men and women \= 18 years of age;
•b)Patient must have UC confirmed by endoscopic and histologic evidence;
•c)Inflammation must be limited to the rectum (up to 15 cm beyond the anal verge), confirmed by endoscopy maximum 3 months before baseline (slight inflammation in other parts of the colon is accepted with a maximum Mayo Score of 1\);
•d)Moderate to severe proctitis indicated by a Mayo Score of 2 or 3;
•e)Proctitis must be refractory to conventional medical therapy. Which means that at some time during the course of the disease, patient must have received rectal 5\-ASA therapy and rectal corticosteroid therapy for at least 4 weeks which did not result in an adequate response to treatment;
•f)If treated with rectal therapy, therapy must be stopped two weeks before endoscopic implantation of MSCs and only restarted after 6 weeks;
•g)If treated with oral 5\-ASA therapy, dose must be stable for 4 weeks prior to study entry and remain on same dose during the first 6 weeks after MSC treatment;
•h)If treated with oral corticosteroids, dose must be stable for 2 weeks prior to study entry and remain on same dose during the first 6 weeks after MSC treatment;
•i)If treated with 6\-mercaptopurine, methotrexate, azathioprine, vedolizumab or anti\-TNF therapy patients must have been on medication for 3 months and a stable dose for 2 months prior to study entry and remain on same dose during the first 6 weeks after MSC treatment;
•j)If female and of child\-bearing age, patient must be non\-pregnant, non\-breastfeeding, and use adequate contraception;

Exclusion Criteria

•a)Patients suffering from renal\- or hepatic failure;
•b)Use of any investigational drug within 1 month prior to screening or within 5 half\-lives of the investigational agent, whichever is longer;
•c)Positive stool culture for enteric pathogens (salmonella, shigella, and campylobacter), positive C. difficile toxin, or positive stool ova and parasite exam;
•d)All active infections requiring treatment;
•e)Patients who had tuberculosis or an opportunistic infection (e.g., herpes zoster \[shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis) within 6 months prior to screening;
•f)Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence);
•g)Any dysplasia in the colon in the past 5 years;
•h)Very severe proctitis; expected to result in hospitalization/ surgery within 3 months;
•i)Previous treatment with allogeneic MSCs;
•j)Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study;