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Myfortic for Type 1 Diabetes Islet Transplant Recipients
Study Summary
This trial is for people who have had a transplant of islet cells (which help produce insulin in the pancreas) that has failed, and now have very low levels of a protein called c-peptide.
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 at least one islet cell transplant.I am between 18 and 70 years old.You are currently using alcohol or drugs excessively.Your liver function tests have shown consistently high levels, which means your liver may not be working properly.You currently have an infection.I have not always followed my prescribed medical treatments.I have untreated severe high cholesterol, obesity, or hard-to-control high blood pressure.I do not have severe heart disease, recent heart attacks, or very poor heart function.I have had cancer before, but it was completely removed except for skin cancer.I am not taking any immunosuppressive medications or have stopped them as required for islet transplantation.Your C-peptide level after stimulation is less than 0.3 ng/ml.I am currently pregnant or breastfeeding.I am mentally stable and can follow the study's procedures.You have a high level of antibodies in your blood or signs of strong sensitivity, as decided by the doctor.I have an active stomach or intestinal ulcer.I have no active infections like hepatitis B, C, HIV, or TB.
- Group 1: Myfortic treatment
- 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
Does this medical trial still have available vacancies?
"The information available on clinicaltrials.gov reveals that the recruitment process is ongoing for this particular study, which was initially posted in January 2009 and last modified in March 2022."
How many individuals are engaging in the research?
"Affirmative. Clinicaltrials.gov confirms that this clinical study, which was posted on January 1st 2009, is actively recruiting participants. The trial requires 18 volunteers to be sourced from a single medical centre."
Do I fulfill the requirements to take part in this research?
"This medical study requires 18 participants with diabetes and/or autoimmune diseases, aged between eighteen and seventy. Additionally, the candidates must be mentally sound and compliant to abide by this trial's protocols; have a history of at least one islet transplantation procedure; not currently prescribed immunosuppressive medications (or if so, need to discontinue them as per protocol); male or female patients."
Does this trial accept applicants who are younger than forty years old?
"The eligiblity requirements for this trial state that the minimum age of entry is 18 years old, with a maximum enrollment age being 70."
Are there any other investigations involving the use of Myfortic?
"Currently, 25 trials concerning Myfortic are in progress. 5 of these experiments have reached Phase 3 while the bulk is located in Saint Louis, Missouri. In total, 265 different sites are running studies on this drug."
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