BridgeMD
Multi-center, single-arm, phase II clinical trial evaluating efficacy and in-vivo homing of adoptively transferred autologous ex-vivo expanded regulatory T cells in adults with ulcerative colitis
EU CTIS ID: 2025-520628-11-00
What this study is testing
The primary objective of this study is to evaluate the rate of clinical remission according to the modified Mayo (mMayo) score at week 12 compared to the day of screening (Mayo subscores of 0 for rectal bleeding, 0 or 1 for stool frequency, and 0 or 1 for endoscopy [modified excluding friability]).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Established diagnosis of active UC, with minimum time from diagnosis of ≥ 3 months and confirmed by endoscopy extending 15 cm or more above the anal verge, with a mMayo score of 5-9, including an endoscopic subscore of ≥ 2 (modified to exclude friability from grade 1), WHO performance status of 0, 1 or 2
- age ≥ 18 years
You likely can't join if
- Seriously impaired hematological, hepatic or renal function, major serious illness, evidence for human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2, Treponema pallidum (TPHA), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, subjects who have spent a cumulative period of 1 year or more in the UK between the beginning of 1980 and the end of 1996, subjects who have a family history which places them at risk of developing Creutzfeldt-Jacob disease
- Subjects who have received a corneal or dura mater graft, or who have been treated in the past with medicines made from human pituitary glands, cancer, splenectomy or radiation therapy of the spleen, organ allografts
- suspicion of differential diagnosis including but not limited to Crohn’s enterocolitis, ischaemic colitis, radiation colitis, indeterminate colitis, infectious colitis, diverticular disease associated colitis, microscopic colitis
- UC limited to the rectum
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.