Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes
- Conditions
- Type 1 DiabetesDiabetes Mellitus, Type 1
- Registration Number
- NCT05626712
- Lead Sponsor
- Creative Medical Technology Holdings Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria:<br><br> 1. Subject must be able to understand and provide signed informed consent.<br><br> 2. Males and females, 18-35 years of age.<br><br> 3. Diagnosis of T1D within 180 days, with stimulated C-peptide peak level >0.6 ng/mL as<br> assessed by 4-hour MMTT at the time of Visit 0 (screening).<br><br> 4. Diagnosed with T1D, according to ADA standard criteria, and confirmed by positivity<br> to at least two islet autoantibodies, GAD65, IA-2, or ZnT8.<br><br> 5. Mentally stable and able to comply with the procedures of the study protocol<br><br> 6. Subjects must be willing to comply with standard-of-care diabetes management.<br><br> 7. Subjects with eGFR >80 ml/min/1.73m2<br><br> 8. Female subjects of childbearing potential must have a negative pregnancy test upon<br> study entry.<br><br> 9. Female (and male) subjects with reproductive potential must agree to use two FDA<br> approved methods of birth control for the entire duration of the study. Potential<br> subjects of childbearing potential should agree to use effective contraception for<br> the entire 2-year period.<br><br> 10. Adequate venous access to support study required blood draws.<br><br>Exclusion Criteria:<br><br> 1. Inability or unwillingness of a subject to give written informed consent or comply<br> with study protocol.<br><br> 2. BMI>28 kg/m.<br><br> 3. HbA1c > 9%<br><br> 4. Subjects with poorly controlled hypertension as defined by systolic blood pressure<br> >140 mmHg or diastolic blood pressure >90 mmHg.<br><br> 5. Subjects with any history of cardiac disease, including but not limited to<br> myocardial infarction, uncompensated heart failure, fluid overload, as well as any<br> clinically significant abnormality identified on prior cardiac stress test,<br> angiogram evaluation, or echocardiogram.<br><br> 6. Subjects with liver disease, portal hypertension, any coagulopathy (including<br> history of Factor V deficiency) or long-term anti-coagulant therapy (except low-dose<br> aspirin). Other hepatic conditions including hepatic anatomic abnormalities or<br> variants that would place the individual at increased risk in the judgment of the<br> investigator are also considered exclusionary.<br><br> 7. Symptomatic cholecystolithiasis; acute or chronic pancreatitis; or current<br> symptomatic peptic ulcer disease.<br><br> 8. Subjects with uncontrolled thyroid disease: thyroid stimulating hormone <0.3 mU/L or<br> >5 mU/L; free T4 <5.0 ug/dL or >11.0 ug/dL.<br><br> 9. Any of the following laboratory findings: hemoglobin <11.5 g/dL (females) or <13.2<br> g/dL (males); leukocytes <3,000/µL; neutrophils <1,500/µL; lymphocytes <800/µL;<br> platelets <100,000/µL; elevation in AST and ALT >2 x ULN (upper limit of normal);<br> LDL cholesterol >160; Triglycerides >3 x ULN; total bilirubin >1.5 x ULN.<br><br> 10. Screening laboratory evidence consistent with significant chronic active infection<br> (i.e.., hepatitis B and C, tuberculosis, and HIV), and IGRA Tuberculosis (Tb) test<br> during screening<br><br> 11. Ongoing acute infections, e.g., acute respiratory tract, urinary tract, or<br> gastrointestinal tract infections.<br><br> 12. Subjects with eating disorders.<br><br> 13. Ongoing or anticipated use of diabetes medications other than insulin.<br><br> 14. Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control<br> within 7 days of screening.<br><br> 15. Recent recipient of any licensed or investigational live attenuated vaccine(s)<br> within 6 weeks of randomization.<br><br> 16. Patients who have participated in previous clinical studies, other than<br> observational studies, will be excluded.<br><br> 17. Concomitant therapy with immunosuppressive drugs, immunomodulators, or cytotoxic<br> agents, or previous therapy less than 3 months from randomization.<br><br> 18. History or diagnosis of malignancy with the exception of a history of localized<br> basal or squamous cell carcinoma.<br><br> 19. Any history of gastroparesis or other severe gastrointestinal disease.<br><br> 20. Presence of an allograft.<br><br> 21. Diagnosed or self-reported drug or alcohol abuse.<br><br> 22. An individual who has a medical, psychological or social condition that, in the<br> opinion of the Principal Investigator, would interfere with safe and proper<br> completion of the trial.<br><br> 23. Pregnancy or ongoing breastfeeding for women; unwillingness or inability of both<br> females and males of childbearing age to use a reliable and effective form of<br> contraception, for the entire 2-year duration of the study.<br><br> 24. Inability to perform any of the assessments required for endpoint analysis.<br><br> 25. Known history of serious allergic reactions, including anaphylaxis to CELZ-201 or<br> its preparation components. Specifically, patients with a prior history of heparin<br> induced thrombocytopenia or any other adverse reaction to heparin, will be excluded.<br><br> 26. The investigator believes that participating in the trial is not in the best<br> interest of the patient, or the investigator considers patient unsuitable for<br> enrollment (such as unpredictable risks or subject compliance issues).<br><br> 27. Positive for coronavirus disease (COVID)-19 by PCR or evidence of active infection<br> per local institutional standards.<br><br> 28. Allergy to iodine contrast or anesthesia<br><br> 29. For female subjects: Pregnant, nursing, or planning to become pregnant during the<br> course of entire duration of the study (approximately little over two years) or<br> unwillingness to comply with contraceptive requirements.<br><br> 30. For male subjects: Male subjects with a female partner who is planning to become<br> pregnant with the male subject during the entire course of the study or<br> unwillingness to comply with contraceptive requirements.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events;Number of Participants with Adverse Events;Glycosylated HbA1C;Insulin Requirement;Islet Autoantibody Levels;Alloreactive Antibody Levels;C-peptide during a 4-hour MMTT