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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CELZ-201 Administration
Biological/VaccineParticipants 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.
Control Group
Other interventionEnhanced standard of care for Type 1 Diabetes treatment only.
Treatment groups
18 Participants
are divided into 2 treatment groupsGroup A: CELZ-201 Treatment GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events
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.
Time frame
6 monthsSecondary outcomes
1
Number of Participants with Adverse Events
Incidence of adverse events (grade 2 or above as per CTCAE version 5.0) in both groups at 12 months.
Time frame
12 months2
Number of Participants with Adverse Events
Incidence of adverse events (grade 2 or above as per CTCAE version 5.0) in both groups at 24 months.
Time frame
24 months3
Glycosylated HbA1C
Changes in glycosylated HbA1c (%)
Time frame
12 months4
Insulin Requirement
Changes in exogenous insulin requirement
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov