Clinical Trial to Evaluate the Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes (CREATE-1)
Overview
- Phase
- Phase 1
- Intervention
- CELZ-201 Administration
- Conditions
- Type 1 Diabetes
- Sponsor
- Creative Medical Technology Holdings Inc
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Number of Participants with Adverse Events
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief 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).
Detailed 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 Group II (Control Arm, n=6) and will receive enhanced standard of care for type 1 diabetes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 ZnT
- •Mentally stable and able to comply with the procedures of the study protocol
- •Subjects must be willing to comply with "standard-of-care" diabetes management.
- •Subjects with eGFR \>80 ml/min/1.73m2
- •Female subjects of childbearing potential must have a negative pregnancy test upon study entry.
- •Female (and male) subjects with reproductive potential must agree to use two FDA approved methods of birth control for the entire duration of the study.
- •Potential subjects of childbearing potential should agree to use effective contraception for the entire 2-year period.
Exclusion Criteria
- •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.
- •Subjects with any history of cardiac disease, including but not limited to myocardial infarction, uncompensated heart failure, fluid overload, as well as any clinically significant abnormality identified on prior cardiac stress test, angiogram evaluation, or echocardiogram.
- •Subjects with liver disease, portal hypertension, any coagulopathy (including history of Factor V deficiency) or long-term anti-coagulant therapy (except low-dose aspirin). Other hepatic conditions including hepatic anatomic abnormalities or variants that would place the individual at increased risk in the judgment of the investigator are also considered exclusionary.
- •Symptomatic cholecystolithiasis; acute or chronic pancreatitis; or current symptomatic peptic ulcer disease.
- •Subjects with uncontrolled thyroid disease: thyroid stimulating hormone \<0.3 mU/L or \>5 mU/L; free T4 \<5.0 ug/dL or \>11.0 ug/dL.
- •Any of the following laboratory findings: hemoglobin \<11.5 g/dL (females) or \<13.2 g/dL (males); leukocytes \<3,000/μL; neutrophils \<1,500/μL; lymphocytes \<800/μL; platelets \<100,000/μL; elevation in AST and ALT \>2 x ULN (upper limit of normal); LDL cholesterol \>160; Triglycerides \>3 x ULN; total bilirubin \>1.5 x ULN.
- •Screening laboratory evidence consistent with significant chronic active infection (i.e.., hepatitis B and C, tuberculosis, and HIV), and IGRA Tuberculosis (Tb) test during screening
Arms & Interventions
CELZ-201 Treatment Group
Participants in this group will receive a single dose of CELZ-201, in addition to standard of care of care for Type 1 Diabetes treatment.
Intervention: CELZ-201 Administration
Control Group
Participants in this group will receive standard of care for Type 1 Diabetes only.
Intervention: Control Group
Outcomes
Primary Outcomes
Number of Participants with Adverse Events
Time Frame: 6 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.
Secondary Outcomes
- Alloreactive Antibody Levels(12 months)
- Number of Participants with Adverse Events(24 months)
- Islet Autoantibody Levels(12 months)
- Glycosylated HbA1C(12 months)
- Insulin Requirement(12 months)
- C-peptide during a 4-hour MMTT(12 months)
- Number of Participants with Adverse Events(12 months)