NCT04061746Active, not recruitingPhase 1
Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
The goal of this study is to determine the safety and efficacy of fresh metabolically active allogeneic umbilical cord-derived mesenchymal stromal cells (UC-MSCs) for the treatment of new-onset type 1 diabetes (T1D) and to understand the mechanisms of protection. If proven effective, such a strategy can be used as a therapeutic option for T1D patients and potentially other autoimmune disorders.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Aug 2019
- Start date
- 27 Feb 2020
- Primary completion date
- 30 May 2027
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Type 1 diabetes
- NCT number
- NCT04061746
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 27 Feb 2020 to the primary completion date, 30 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of malignancy
- Subject is being treated for severe active infection of any type
- Subject with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. severe psychiatric, hematologic, renal, hepatic, neurologic, cardiac, or respiratory disorder)
Lab values
- 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).
Other
- Evidence of retinopathy at baseline based on ophthalmologic examination or medical record review.
- Body Mass Index \< 14 or \>35
- 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
- A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.