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Remestemcel-L for Granulomatous Colitis
Study Summary
This trial is testing whether bone marrow-derived stem cells can help treat Crohn's colitis when other medical treatments have failed.
- Granulomatous Colitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 3 trial • 32 Patients • NCT02652130Trial Design
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Who is running the clinical trial?
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- If you are taking budesonide, you must have been taking the same amount consistently for at least 2 weeks.You have taken antibiotics to treat ulcerative colitis for at least two weeks.Your health condition has not gotten worse, and may have even improved.If you stopped taking oral 5-ASA compounds or oral corticosteroids (including budesonide), you must have stopped taking them at least 2 weeks ago.You were given a fake medication (placebo) during your first injection.You are allowed to have taken certain medications before, but you need to stop taking any monoclonal antibodies for 4 weeks before the trial.
- Group 1: remestemcel-L (150 million cells)
- Group 2: Placebo
- Group 3: remestemcel-L (300 million cells)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can you provide a synopsis of the research surveying Remestemcel-L's effects?
"Currently, three clinical trials are underway for Remestemcel-L. None of them have entered Phase 3 yet. The primary study location is in Cleveland Ohio; however, other places around the country are also enrolling participants."
Who is appropriate for inclusion in this trial?
"The requirements to be part of this clinical trial include a diagnosis of granulomatous colitis and being between the ages of 18 and 75. As such, 24 individuals are currently being sought out for enrolment."
Are there any remaining available slots for participation in this clinical investigation?
"This clinical trial is accepting participants, as evidenced by its listing on clinicaltrials.gov; the initial post was made on November 4th 2020 and has been updated most recently on April 4th 2022."
Does this investigation offer participation to those above the age of seventy-five?
"This trial is open to individuals aged 18-75. For those below the age of majority, there are 98 studies available and 347 for senior citizens above 65 years old."
How many participants are eligible for enrollment in this experiment?
"Affirmative. Per clinicaltrials.gov, this medical trial has been recruiting since November 4th 2020 and is currently still enrolling patients. 24 participants need to be sourced from a single facility."
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