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Stem Cell Mobilization + Immunotherapy for Type 1 Diabetes
Study Summary
This trial is based on the "immunological reset" approach to treat type 1 diabetes. T-depletion therapy and anti-inflammatory treatment will restore self-tolerance in T1DM patients. Autologous, peripheral-blood mobilized hematopoietic CD34+-enriched stem cells and a long-acting GLP-1 analogue will promote pancreatic islet regeneration and repair.
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 2017 Phase 4 trial • 8 Patients • NCT01395316Trial Design
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- I understand the study's risks and have signed the consent form.My hemoglobin level is below the normal range for my gender.I use more than 1 unit of insulin per kilogram of my body weight daily.I do not have severe heart problems like recent heart attacks or very weak heart pumping.You have been using alcohol, drugs, or smoking heavily, and need to stop for at least 6 months before joining the study.You have a history of not following your doctor's instructions for taking medicine.Your liver function tests must be within the normal range, unless you have uncomplicated Gilbert's Syndrome.I am not pregnant, not planning to become pregnant, not breastfeeding, and I follow effective contraceptive measures.I have Graves' disease but have been treated with radioiodine.I or my family have a history of MEN2 or medullary thyroid cancer.You are allergic to a protein derived from E. coli.I am taking blood thinners other than aspirin, or my blood clotting time is longer than normal.You have been diagnosed with type 1 diabetes using specific criteria.I have not had a serious infection in the last 3 weeks.You have a history of having a lot of protein in your urine.I have an untreated eye condition where new blood vessels grow abnormally.I am suspected to have rapidly worsening kidney problems.I have not had major surgery in the last 30 days.Your HbA1C level is higher than 12% at the screening.I am on long-term steroids for another health issue.I have a history of cancer other than non-melanoma skin cancer.I do not have active infections like Hepatitis C, B, HIV, or tuberculosis.Your pancreas still produces a certain amount of insulin, as measured by a test called MMTT.You have a very high body mass index (BMI) at the screening visit.You have a high amount of the EBV virus in your blood, as measured by a specific test.I have had Type 1 Diabetes for more than 6 months.I am between 18 and 45 years old.I have Celiac disease that has not been treated.I am either younger than 18 or older than 45 years old.Your lab test results show important problems, except those related to type 1 diabetes.Your kidney function is too low, with a GFR less than 60.You have a positive test for syphilis.I have tested positive for one or more autoantibodies confirming Type 1 Diabetes.My cholesterol levels are very high and not under control.I have not received a live vaccine in the last 30 days.I haven't taken strong immune-weakening drugs in the last 30 days.
- 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 people still being accepted into the experimental group for this research?
"According to the latest information on clinicaltrials.gov, this trial is not looking for any more participants at present time. The study was originally posted on August 15th, 2017 and updated as recently as July 6th, 2022. Although this particular trial isn't seeking patients right now, there are 1,457 other studies that are actively recruiting candidates."
How many test subjects are a part of this research?
"This study is not recruiting at the moment, as per the latest update on July 6th, 2022. The clinical trial was first posted on August 15th, 2017. However, there are many other trials seeking patients with diabetes and autoimmune disorders that you may be eligible for. For example, there are presently 1304 trials actively looking for participants with diabetes and 153 studies for Alemtuzumab admitting patients."
What other drugs has Alemtuzumab been tested with in clinical trials?
"As of now, there are 153 ongoing clinical trials for Alemtuzumab. Out of these, 28 have reached Phase 3. Most of the research teams conducting these studies are based in Philadelphia, Pennsylvania; although, in total, there are 1454 locations where these trials are taking place."
Would I be a good candidate for this clinical trial?
"Up to 60 patients that have diabetes and an autoimmune disease, between the ages of 18-45, can be enrolled in this study. The most crucial requirements for candidates are as follows: being free from any condition which would rule them out at PI's discretion and being within the age range of 18-45."
What are the most frequent indications for Alemtuzumab?
"Alemtuzumab is most frequently used to combat cardiovascular disease (cvd), but it can also be used as part of a treatment plan for systemic juvenile idiopathic arthritis (sjia), neonatal-onset multisystem inflammatory disease (nomid) and for hematopoietic stem cell mobilization therapy."
Can young adults participate in this research project?
"If patients meet the age requirement of 18 to 45 years old, they may be eligible for this clinical trial. However, there are 272 trials specifically designed for people under 18 and 1073 trials meant for those over 65."
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