Actively Recruiting
Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes
Led by Creative Medical Technology Holdings Inc · Updated on 2026-02-19
18
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide signed informed consent
- Male or female aged 18 to 35 years
- Diagnosis of Type 1 Diabetes within 1 year with stimulated C-peptide peak level >0.6 ng/mL
- Confirmed Type 1 Diabetes diagnosis with at least two positive islet autoantibodies (GAD65, IA-2, or ZnT8)
- Mentally stable and able to follow study procedures
- Willing to comply with standard diabetes care
- Estimated glomerular filtration rate (eGFR) >80 ml/min/1.73m2
- Negative pregnancy test for females of childbearing potential
- Agree to use two FDA-approved birth control methods throughout the study duration
- Adequate venous access for required blood draws
You will not qualify if you...
- Unable or unwilling to provide informed consent or follow study protocol
- Body mass index (BMI) greater than 28 kg/m2
- HbA1c greater than 9%
- Poorly controlled hypertension (blood pressure >140/90 mmHg)
- History of cardiac disease or significant heart abnormalities
- Liver disease, portal hypertension, bleeding disorders, or long-term anticoagulant use (except low-dose aspirin)
- Symptomatic gallstones, pancreatitis, or active peptic ulcer disease
- Uncontrolled thyroid disease
- Certain abnormal blood test results including low hemoglobin, leukocytes, neutrophils, lymphocytes, platelets, or elevated liver enzymes and cholesterol
- Evidence of chronic active infections or positive tuberculosis or HIV tests
- Current acute infections
- Eating disorders
- Use of diabetes medications other than insulin or non-insulin drugs affecting blood sugar within 7 days of screening
- Recent live attenuated vaccine within 6 weeks
- Prior participation in interventional clinical trials
- Use of immunosuppressive or immunomodulatory drugs within 3 months
- History of cancer except localized basal or squamous cell carcinoma
- Severe gastrointestinal diseases
- Presence of an allograft
- History of drug or alcohol abuse
- Any condition that may interfere with safe trial completion
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Inability to complete required assessments
- Known serious allergies to CELZ-201 or related components
- Investigator judgment deeming participation unsafe
- Positive COVID-19 test or active infection
- Allergy to iodine contrast or anesthesia
- For females, pregnant, nursing, or planning pregnancy during study
- For males, female partner planning pregnancy during study or unwilling to use contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
C
Creative Medical Technology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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