Allogeneic bone marrow derived mesenchymal stromal cells for the treatment of refractory proctitis in Ulcerative Colitis

Phase 2

Recruiting

• Conditions: Ulcerative Colitis; 10017969

• Registration Number: NL-OMON48876
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

a) Men and women >= 18 years of age;
b) Patient must have ulcerative colitis 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;
k) Patient is willing to participate in the study and has signed the informed consent.
Consent must be obtained prior to any study procedure.

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, except for a successfully removed sporadic adenoma;
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;
k) Patient is unwilling or unable to comply with the study procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The safety, tolerability and feasibility of endoscopic injected MSCs in the<br /><br>distal colon of patients with refractory proctitis after 6 weeks.</p><br>