Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled just one participant — a child or young adult with inflammatory bowel disease (IBD). The trial was testing an infusion treatment using a type of cell called mesenchymal stromal cells (MSCs), which are cells derived from donated bone marrow. The participant received weekly infusions over 8 weeks and was then monitored for up to 2 years afterwards. The main thing the trial was set up to measure was how often participants experienced serious or non-serious unwanted health events, or stopped treatment early. The reported data shows that 1 out of 1 participant experienced an adverse event (an unwanted health event) during the study. No further breakdown of what that event involved was provided in the submitted results. The trial also intended to measure whether participants showed a meaningful improvement in their IBD symptoms (using standard scoring tools) and whether certain blood and stool tests showed changes — however, the reported data shows that no results were submitted for either of those two secondary outcome measures, so those figures are not available. It is worth noting that with only one person taking part, this trial was extremely small — far too small to draw any broad conclusions. According to the results reported on ClinicalTrials.gov, this appears to have been an early-stage study, likely focused on feasibility and initial safety monitoring rather than proving anything definitive about the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 1 Crohn's Disease and Colitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 17 and 22 years old (young adult group) OR between 12 and 16 years old (pediatric group)
- You have been diagnosed with moderately to severely active Crohn's disease or ulcerative colitis, confirmed by a scope procedure or special MRI scan within the last 2 months
- Your disease has not responded well to, or you could not tolerate, a biologic medication (a type of powerful anti-inflammatory drug)
- You are currently taking certain medications such as steroids (at lower doses), methotrexate, or other bowel disease medicines — these are allowed during the trial
- You (or your parent/guardian if you are a minor) are able to give informed consent to participate
Who may not be able to join:
- You are younger than 12 or older than 22 years of age
- You are pregnant or breastfeeding, or a pregnancy test comes back positive at screening or during the trial
- You have a very serious bowel complication such as a severely swollen colon or a hole in the intestine
- You have certain liver conditions, such as autoimmune hepatitis or sclerosing cholangitis
- You have a high fever (above 39°C/102.2°F) or a significant active infection — including HIV, Hepatitis B or C, a urinary tract infection, or a respiratory infection — within the past week
- You have taken an unapproved drug or certain small molecule medications (such as naltrexone) within the last 60 days
- You are taking more than 20 mg of prednisone (a steroid) per day (or more than 0.5 mg per kg of body weight per day if you weigh less than 40 kg)
- Your blood test results show serious abnormalities, such as very low white blood cell counts, low red blood cell levels, low platelets, or signs that your kidneys or liver are not working well (confirm with trial site)
- You have an active gut infection, such as a positive stool culture or a C. difficile infection
- You have had bowel surgery (other than minor procedures around the anal area) within the last 3 months
- You have an eye condition called uveitis
- You have a known lung disease, other than mild occasional asthma
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Number of Subjects Who Experience Serious Adverse Events, Adverse Events, and/or Early Treatment Discontinuations.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.