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Stem Cell Therapy for Ulcerative Colitis
Study Summary
This trial is testing whether using a person's own stem cells can help treat Ulcerative 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.Trial Design
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Who is running the clinical trial?
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- I have had a C. Diff infection in the last 30 days.I have a colon tumor and had a biopsy before surgery.I have a history of hepatitis B, C, or HIV.I have had part of my colon removed.I haven't taken any experimental drugs in the last 30 days.I am between 18 and 65 years old.I might have Crohn's disease or an unclear type of colitis.I have a medical condition related to my body fat.I have tried at least 2 standard treatments for UC without success.I haven't had major heart issues or other serious health problems in the last 6 months.I agree to use effective birth control during the study.I had a colonoscopy within the last year to check for cancer.I have a condition that increases my risk of blood clots.I have had cancer before, but not including minor skin cancers.I have severe colon issues, including an ostomy or ileoanal pouch.I am capable of understanding and signing the consent form.My ulcerative colitis is severe and not responding to standard treatments.I am currently taking medications like corticosteroids or antibiotics.
- Group 1: Autologous mesenchymal stem cells
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any enrolment slots available for this medical experiment?
"Affirmative. Clinicaltrials.gov attests to this medical trial's recruitment status, which began on November 16th 2020 and was most recently modified on September 30th 2022. The study requires the enrollment of 20 patients from a single site."
Is the age requirement for participants in this trial beyond forty years old?
"The age parameters for this medical trial are 18 to 65 years old. In addition, there are 70 trials specifically targeting minors and 347 studies focusing on a geriatric patient population."
What is the total number of participants in this clinical trial?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial is looking for enrollees, with the initial posting date being November 16th 2020 and last edit on September 30th 2022. The study requires 20 candidates from 1 centre to participate in the experiment."
To what extent can autologous mesenchymal stem cells from adipose tissue be detrimental to health?
"As this is a phase 1 trial, and thus limited data exists regarding the safety and efficacy of adipose derived autologous mesenchymal stem cells, our team at Power assesses its risk level as a score of one."
May I be admitted as a participant in this experiment?
"This trial is seeking twenty people between the ages of eighteen and sixty-five who are suffering from ulcerative colitis. To qualify, patients must have experienced persistent symptoms over a 12 week period while using FDA approved medications, passed an adapted Mayo Score of 5 - 9 points with an endoscopic sub score ranging 2 - 3, and failed at least two standard treatments. Concurrent therapies such as corticosteroids or anti-integrin drugs may be allowed in certain cases following medical evaluation. Furthermore, male and female participants must have undergone colonoscopy within the past year to exclude malignant pathologies."
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