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Stem Cell Educator Therapy for Type 1 Diabetes
Study Summary
This trial uses a patient's own immune cells that are "educated" by cord blood stem cells in order to improveC-peptide levels, reduce median glycated hemoglobin A1C (HbA1C) values, and decrease median daily usage of insulin in Type 1 diabetes (T1D) patients.
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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- Your liver enzymes (AST or ALT) are higher than a certain limit.I am on a blood thinner that is not aspirin.You are pregnant or breastfeeding.Your creatinine level is higher than 2.0 mg/dl.You have any other autoimmune diseases, like lupus or rheumatoid arthritis.I am willing to use birth control as recommended until 6 months after treatment ends.I haven't taken any immunosuppressive drugs in the last month.Your C-peptide level is higher than 0.3 ng/ml when you haven't eaten.I am 14 years old or older.My veins are suitable for apheresis.I have heart disease or an EKG that suggests heart disease but have been cleared by a cardiologist.You need to have a continuous glucose monitoring system.I have been diagnosed with type 1 diabetes according to the 2015 ADA criteria.Your HbA1C level is less than 10% when you join the study.My blood test shows I have antibodies against pancreatic cells.Your hemoglobin is less than 10 grams per deciliter or your platelet count is less than 100 thousand per microliter.Your bilirubin levels are higher than normal.I was diagnosed within the last two years.I do not have active infections like Hepatitis B, C, or HIV.I cannot or do not want to give permission for treatment.
- Group 1: Treatment of T1D with Stem Cell Educator therapy
- Group 2: Conventional insulin therapy
- 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 new patients being accepted for this clinical trial currently?
"Based on the information available from clinicaltrials.gov, this research is currently recruiting patients. The study was first announced on 9/20/2022 and updated as recently as yesterday (9/19/2022)."
How many people are enrolled in this experiment at most?
"That is accurate. According to the information available on clinicaltrials.gov, this study was posted on 9/20/2022 and is currently seeking candidates for participation. They are looking for 50 individuals across 1 site."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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