Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Evaluating Treatment with Autologous Regulatory T-cells Given by Infusion in Adults with Ulcerative Colitis

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with ulcerative colitis, a chronic inflammatory bowel disease that causes inflammation and sores in the digestive tract. The study evaluates a new treatment approach using autologous regulatory T-cells, which are special immune cells taken from the patient's own body, modified and expanded in a laboratory, and then returned through an intravenous infusion.

The treatment involves collecting the patient's own immune cells, specifically T-cells that help regulate the immune system. These cells are processed in a laboratory to increase their numbers and then given back to the patient through an intravenous infusion. The treatment, known as Treg therapy, will be administered over a period of two months.

The purpose of this study is to determine if this cell therapy can help achieve remission in people with ulcerative colitis, meaning a reduction in symptoms such as bleeding and frequent bowel movements. The study will monitor patients for 12 weeks after receiving the treatment to evaluate its effectiveness. Each patient may receive up to two infusions of the processed immune cells during the study period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    Your condition will be evaluated using the modified Mayo score, which measures the severity of ulcerative colitis

    An endoscopy examination will be performed to assess the condition of your colon

    The examination will cover an area extending at least 15 centimeters above the anal opening

  2. Step 2

    Collection of T-cells

    A blood sample will be taken to collect your T-cells (a type of immune system cell)

    These cells will be processed in a laboratory to increase their numbers

  3. Step 3

    Treatment administration

    You will receive an intravenous infusion (through a vein) of your processed T-cells

    The infusion contains your own regulatory T-cells that have been specially prepared in the laboratory

  4. Step 4

    Follow-up period

    Your condition will be monitored for 12 weeks after the treatment

    At week 12, another endoscopy will be performed

    Your symptoms will be evaluated using the modified Mayo score to assess:

    - Bleeding from the rectum

    - Frequency of bowel movements

    - Appearance of the colon during endoscopy

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must have been diagnosed with active ulcerative colitis for at least 3 months
  • Must have inflammation extending at least 15 centimeters above the anal opening, confirmed by endoscopy (a procedure where a camera is used to look inside the colon)
  • Must have a modified Mayo score between 5 and 9 (a scoring system that measures disease activity)
  • Must have an endoscopic subscore of 2 or higher (indicating moderate to severe inflammation seen during endoscopy)
  • Must have a WHO performance status of 0, 1, or 2 (a scale that measures a person's ability to perform daily activities, where 0 means fully active and 2 means able to do light activities)
  • Both men and women can participate in the study

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years old
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to medications
  • Current active infection or serious infection within the past 3 months
  • History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Severe liver disease (when liver does not function properly)
  • Severe kidney disease (when kidneys do not function properly)
  • Current treatment with other biological medications for ulcerative colitis
  • Having received live vaccines within 4 weeks before starting the study
  • Severe heart conditions or uncontrolled high blood pressure
  • History of blood disorders or significant abnormal blood test results
  • Current participation in other clinical trials
  • Alcohol or drug abuse within the past 6 months
  • Mental health conditions that could interfere with study participation
  • Unable to follow study procedures or attend scheduled visits
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Regulatory T cells (Tregs) This therapy uses the patient's own immune cells called regulatory T cells (Tregs). These cells are first collected from the patient's blood, then grown and multiplied in a laboratory (ex-vivo expansion). After processing, these cells are given back to the patient through an infusion. Tregs help control inflammation and maintain balance in the immune system, which is particularly important for people with ulcerative colitis. The treatment aims to reduce inflammation in the bowel by using these specially processed immune cells.

What is already known about the treatment

Since no specific medication names are provided in the source data, I can describe the main therapeutic approach mentioned in the trial: Regulatory T cells (Tregs) – This is a cell-based therapy where a patient's own regulatory T cells are collected, expanded in laboratory conditions (ex-vivo), and then reinfused back into the patient's body. The treatment is administered through intravenous infusion and is being investigated for treating ulcerative colitis, an inflammatory bowel disease. Regulatory T cells work by suppressing excessive immune responses and inflammation in the gut, helping to restore normal immune balance. This experimental therapy belongs to the class of cellular immunotherapies and represents a personalized medicine approach where the patient's own cells are used as the therapeutic agent.

Investigated diseases

Ulcerative colitis - A chronic inflammatory bowel disease that affects the large intestine (colon) and rectum. The condition causes inflammation and sores (ulcers) in the digestive tract's innermost lining. The disease typically begins in the rectum and lower colon but may spread continuously to involve the entire colon. Patients experience recurring periods of active disease and remission. The inflammation leads to frequent bowel movements, diarrhea, abdominal pain, and rectal bleeding. The condition can develop gradually or suddenly, and symptoms range from mild to severe.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520628-11-00Estimated enrolment30 patientsSponsorUniversitaetsklinikum Erlangen AöR

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.