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Mesenchymal Stem Cells
Stem Cell Therapy for Type 1 Diabetes
Phase 1
Recruiting
Led By Hongjun Wang, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Positivity for at least one T1D-associated autoantibody, such as GAD, IA-2 or ZnT8 autoantibodies
Male and female between the ages of 18 and 30
Must not have
Subjects with HgbA1c >12%, and/or fasting blood glucose >270 mg/dL and/or frequent episodes of hypoglycemia (>2 episodes per week of blood glucose levels <60 mg/dL)
Subject is being treated for severe active infection of any type
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the course of 1 year (0, 1, 3, 6, 12 months)
Summary
This trial is testing if special cells from umbilical cords can help young adults with Type 1 diabetes by calming their immune system and reducing inflammation. These cells pose a lesser risk of viral contamination due to low placental transmission during prenatal life.
Who is the study for?
This trial is for individuals aged 18-30 recently diagnosed with Type 1 Diabetes, having some remaining insulin-producing cell function and positive for specific diabetes-related autoantibodies. They must be mentally stable, able to manage their diabetes intensively, and have normal blood counts and liver function. Excluded are those with severe infections, certain eye diseases, extreme body weights, high blood pressure or lipids, pregnancy or intent to become pregnant during the study.
What is being tested?
The trial is testing the safety and effectiveness of using umbilical cord-derived mesenchymal stem cells (UC-MSCs) compared to a placebo in treating new-onset Type 1 Diabetes. The aim is to see if these cells can help manage the disease by preserving insulin production.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include immune reactions since MSCs are involved; however this will be closely monitored as part of assessing the treatment's safety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have antibodies linked to type 1 diabetes.
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I am between 18 and 30 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood sugar levels are very high or I often have very low blood sugar.
Select...
I am currently being treated for a severe infection.
Select...
My LDL cholesterol or triglycerides are more than three times the normal limit.
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I do not have severe health issues unrelated to diabetes.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
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I have been diagnosed with cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over the course of 1 year (0, 1, 3, 6, 12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the course of 1 year (0, 1, 3, 6, 12 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
12 month Change in C-peptide area under the curve after a 2-hour MMTT
Secondary study objectives
1 year peak C-peptide after a 2-hour MMTT
6 Month Change in C-Peptide area under the curve after a 2-hour MMTT
6 Month peak C-peptide after a 2-hour MMTT
+1 moreOther study objectives
Change in autoantigen specific T-cell response
Change in beta cell death measurements
Change in blood T-reg number and function
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A TreatmentExperimental Treatment1 Intervention
2.5 x 10\^6 MSC per kg will be infused intravenously on Day 1
Group II: Group B PlaceboPlacebo Group1 Intervention
Plasmalyte with 0.5% Human Serum Albumin will be infused intravenously on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesenchymal Stem Cells (MSCs)
2017
Completed Phase 2
~50
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Type 1 Diabetes (T1D) include insulin therapy, which replaces the insulin that the body can no longer produce, and immunomodulatory therapies that aim to preserve or restore beta-cell function. Treatments like Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs) are being studied for their potential to modulate the immune system and repair tissue.
UC-MSCs may help prevent the immune system from attacking insulin-producing beta cells and promote tissue regeneration, which could preserve or restore the body's ability to produce insulin. This is crucial for T1D patients as it addresses the root cause of the disease and could reduce the need for lifelong insulin therapy.
Current progress in stem cell therapy for type 1 diabetes mellitus.Mesenchymal stromal cells to halt the progression of type 1 diabetes?
Current progress in stem cell therapy for type 1 diabetes mellitus.Mesenchymal stromal cells to halt the progression of type 1 diabetes?
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
968 Previous Clinical Trials
7,399,640 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,439 Previous Clinical Trials
4,324,764 Total Patients Enrolled
Hongjun Wang, PhDPrincipal Investigator - Medical University of South Carolina
Medical University of South Carolina
1 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to follow a strict diabetes management plan.My blood sugar levels are very high or I often have very low blood sugar.Before the study starts, patients must have some remaining ability for their pancreas to produce insulin.I am currently being treated for a severe infection.You have signs of retinopathy in your eyes.Your body mass index is very low or very high.I am mentally stable and can follow the study's procedures.I have antibodies linked to type 1 diabetes.My LDL cholesterol or triglycerides are more than three times the normal limit.I do not have severe health issues unrelated to diabetes.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.Your blood and organ function tests must show normal levels within a specific range. For example, your white blood cell count should be between 4,500 and 11,000.I have been diagnosed with cancer.I was diagnosed with Type 1 Diabetes within the last 6 months.I am between 18 and 30 years old.Your blood pressure is higher than 160 over 100 when you agree to join the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group A Treatment
- Group 2: Group B Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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