Using stem cells from umbilical cords to treat Type 1 diabetes
Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells
PHASE1 · Medical University of South Carolina · NCT04061746
This study is testing if stem cells from umbilical cords can help young adults with newly diagnosed Type 1 diabetes manage their condition better.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT04061746 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of allogeneic umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in patients with new-onset Type 1 diabetes (T1D) diagnosed within the last six months. Participants aged 18 to 40 will receive either the stem cell treatment or a placebo, and the study will monitor their health and diabetes management over the course of one year. The research seeks to understand how these stem cells may protect against the autoimmune destruction of insulin-producing cells in the pancreas. If successful, this approach could offer a new therapeutic option for T1D and potentially other autoimmune diseases.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 40 who have been diagnosed with Type 1 diabetes within the last six months and have residual insulin-producing cell function.
Not a fit: Patients who do not have a recent diagnosis of Type 1 diabetes or those who do not meet the specific autoantibody and C-peptide criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective therapy for managing Type 1 diabetes.
How similar studies have performed: Previous studies have shown promising results with mesenchymal stem cell therapies in suppressing autoimmune diseases, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * A new diagnosis of T1D based on the ADA criteria within 6 months of randomization. * Male and female between the ages of 18 and 40 * Mentally stable and able to comply with the procedures of the study protocol * Positivity for at least one T1D-associated autoantibody, such as GAD, IA-2 or ZnT8 autoantibodies * At screening, patients must have residual β cell function with a stimulated peak C-peptide \>0.2 nmol/l during a 2 hour MMTT * Must be willing to comply with "intensive diabetes management" (\* See diabetes management at MUSC below) as directed by the participant's clinician with the goal of maintaining blood glucose as close to normal as possible * Subject must be willing to comply with the schedule of study visits and protocol requirements * Subject with normal laboratory values of: White blood cell counts: between 4,500 to 11,000 per microliter; Platelet counts: 140,000 to 450,000 platelets per microliter of blood; Serum creatinine range is 0.6-1.3 mg/dL, Hepatic function: ALT 5 to 55 units per liter (U/L), AST 5 to 48 U/L. Exclusion criteria: * Evidence of retinopathy at baseline based on ophthalmologic examination or medical record review. * Body Mass Index \< 14 or \>35 * Presence of malignancy * Subject has abnormally high lipid levels that exceeds \> 3 times the upper limit of normal for LDL cholesterol or triglycerides * Subject has blood pressure greater than 160 mmHg systolic or 100 mmHg diastolic at time of consent * Subject is being treated for severe active infection of any type * A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study. * Subject with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. severe psychiatric, hematologic, renal, hepatic, neurologic, cardiac, or respiratory disorder) * 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).
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Hongjun Wang, PhD — Medical University of South Carolina
- Study coordinator: Leah Benn, MPH
- Email: bennle@musc.edu
- Phone: 843-792-2813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 1, mesenchymal stem cells, diabetes, autoantibodies, C-peptide, Type 1 diabetes mellitus