Could stem cells help newly diagnosed type 1 diabetes patients?
NCT ID NCT04061746
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests whether a single infusion of umbilical cord stem cells can safely preserve insulin production in adults newly diagnosed with type 1 diabetes. Sixty participants will receive either the stem cells or a placebo. The main goal is to see if the treatment protects the cells that make insulin, potentially reducing the need for insulin injections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- umbilical cord-derived mesenchymal stem cells (MSCs)
- What this could lead to
- If it works, this could help people with new-onset type 1 diabetes keep making some of their own insulin, reducing the need for daily insulin shots.
- What could go wrong
- This is an early Phase 1 trial focused on safety, so it is not yet proven to work. The effects may be small or temporary, and there are risks from the infusion itself.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2020
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 40 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetes mellitus, type 1 are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a glucose app that predicts lows calm diabetes fears?
- Could type 1 diabetes hide liver problems in children?
- Can a Weight-Loss drug slow stomach emptying in type 1 diabetes?
- Can pressurized oxygen tame blood sugar spikes?
- Could a virtual life-coach program help young adults tame type 1 diabetes?
- Can Real-World data improve diabetes care in pregnancy?