Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-35
SponsorCreative Medical Technology Holdings Inc
About this trial
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).
Eligibility criteria
Qualifiers
Subject must be able to understand and provide signed informed consent.
Males and females, 18-35 years of age.
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).
Diagnosed with T1D, according to ADA standard criteria, and confirmed by positivity to at least two islet autoantibodies, GAD65, IA-2, or ZnT8.
Disqualifiers
Inability or unwillingness of a subject to give written informed consent or comply with study protocol.
BMI>28 kg/m.
HbA1c > 9%
Subjects with poorly controlled hypertension as defined by systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg.
Trial design
Treatments tested in this trial
- CELZ-201 Administration
- Control Group
Treatment groups
18 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov