Clinical Trial to Evaluate the Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes (CREATE-1)
Creative Medical Technology Holdings Inc
Summary
The brief purpose of this research study is to learn about the safety and efficacy of intra-arterial administration of CELZ-201 in patients with newly diagnosed Type 1 Diabetes Mellitus (T1D).
Description
The proposed study is a Phase I/IIa randomized, controlled clinical trial to evaluate CELZ-201 therapy as an intervention for the treatment of recent onset Type 1 Diabetes. The objective is to determine the safety and efficacy of CELZ-201 administration, based on the timing and dose of CELZ-201 treatment. Subjects who meet eligibility criteria will be randomized to treatment or control groups, in a 2:1 ratio. Subjects in the Group I (Treatment Group, n=12) will receive standard of care for type 1 diabetes and CELZ-201 within 1 month from enrollment (within 1 year of diagnosis). Subjects in Gro…
Eligibility
- Age range
- 18–35 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject must be able to understand and provide signed informed consent. 2. Males and females, 18-35 years of age. 3. Diagnosis of T1D within 1 year, with stimulated C-peptide peak level \>0.6 ng/mL as assessed by 4-hour MMTT at the time of Visit 0 (screening). 4. Diagnosed with T1D, according to ADA standard criteria, and confirmed by positivity to at least two islet autoantibodies, GAD65, IA-2, or ZnT8. 5. Mentally stable and able to comply with the procedures of the study protocol 6. Subjects must be willing to comply with "standard-of-care" diabetes management. 7. Su…
Interventions
- BiologicalCELZ-201 Administration
Participants in this group will receive a single dose of CELZ-201, in addition to standard of care for Type 1 Diabetes treatment. Perinatal tissue derived cells will be administered at a dose of 1x10\^6 cells/kg via an intra-arterial infusion into the dorsal pancreatic artery.
- OtherControl Group
Enhanced standard of care for Type 1 Diabetes treatment only.
Location
- Diabetes Research Institute, University of Miami Miller School of MedicineMiami, Florida