CELZ-201 for Recent Onset Type 1 Diabetes
This study is testing a treatment called CELZ-201 for people recently diagnosed with Type 1 Diabetes. Researchers want to see if CELZ-201 is safe and effective in slowing down the disease. You might be able to join if you are 18-35 years old and were diagnosed with Type 1 Diabetes within the last year, and have a specific C-peptide level (a measure of insulin production). Participants will either receive a single dose of CELZ-201 along with standard care, or enhanced standard care alone. The main goal is to track any side effects over 6 months. This study is currently recruiting 18 participants.
- Study design
- This is a Phase I/IIa randomized, controlled study with 18 participants. Participants will be assigned to either the CELZ-201 treatment group or a control group.
- What's involved
- Participants in the treatment group will receive a single dose of CELZ-201 via an intra-arterial infusion (a shot into an artery). All participants will receive standard or enhanced standard care for Type 1 Diabetes.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track adverse events (side effects) for 6 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Francesco Vendrame, MD · PRINCIPAL_INVESTIGATOR · University of Miami, Diabetes Research Institute
Who to contact
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What this trial measures
- Number of Participants with Adverse Events6 months
The primary outcome to be assessed is tolerability and safety of the CELZ-201 therapy. The incidence of adverse events (grade 2 or above as per CTCAE version 5.0) in both groups at 6 months.