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Tests treatment safety and results for Type 1 Diabetes
Official title Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes
ClinicalTrials.gov ID: NCT05626712
What this study is testing
What is CELZ-201 Administration?
CELZ-201 Administration is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for type 1 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35
You may be able to join if
- 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.
- Mentally stable and able to comply with the procedures of the study protocol
You likely can't join if
- Inability or unwillingness of a subject to give written informed consent or comply with study protocol.
- BMI\>28 kg/m.
- HbA1c \> 9%
- people with poorly controlled hypertension as defined by systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg.
- people with any history of cardiac disease, including but not limited to myocardial infarction, uncompensated heart failure, fluid overload, as well...
- people with liver disease, portal hypertension, any coagulopathy (including history of Factor V deficiency) or long-term anti-coagulant therapy...
See the full eligibility 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 ZnT8.
- Mentally stable and able to comply with the procedures of the study protocol
- people must be willing to comply with "standard-of-care" diabetes management.
- people with eGFR \>80 ml/min/1.73m2
- Female people of childbearing potential must have a negative pregnancy test upon study entry.
- Female (and male) people with reproductive potential must agree to use two FDA approved methods of birth control for the entire duration of the study. Potential people of childbearing potential should agree to use...
- Adequate venous access to support study required blood draws.
- Inability or unwillingness of a subject to give written informed consent or comply with study protocol.
- BMI\>28 kg/m.
- HbA1c \> 9%
- people with poorly controlled hypertension as defined by systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg.
- people 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...
- people 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...
- Symptomatic cholecystolithiasis; acute or chronic pancreatitis; or current symptomatic peptic ulcer disease.
- people with uncontrolled thyroid disease: thyroid stimulating hormone \ 5 mU/L; free T4 \ 11.0 ug/dL.
- Any of the following laboratory findings: hemoglobin \ 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
- Ongoing acute infections, e.g., acute respiratory tract, urinary tract, or gastrointestinal tract infections.
- people with eating disorders.
- Ongoing or anticipated use of diabetes medications other than insulin.
- Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within 7 days of screening.
- Recent recipient of any licensed or investigational live attenuated vaccine(s) within 6 weeks of randomization.
- Patients who have participated in previous clinical studies, other than observational studies, will be excluded.
- Concomitant therapy with immunosuppressive drugs, immunomodulators, or cytotoxic agents, or previous therapy less than 3 months from randomization.
- History or diagnosis of malignancy with the exception of a history of localized basal or squamous cell carcinoma.
- Any history of gastroparesis or other severe gastrointestinal disease.
- Presence of an allograft.
- Diagnosed or self-reported drug or alcohol abuse.
- An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
- Pregnancy or ongoing breastfeeding for women; unwillingness or inability of both females and males of childbearing age to use a reliable and effective form of contraception, for the entire 2-year duration of the study.
- Inability to perform any of the assessments required for endpoint analysis.
- Known history of serious allergic reactions, including anaphylaxis to CELZ-201 or its preparation components. Specifically, patients with a prior history of heparin induced thrombocytopenia or any other adverse reaction...
- The investigator believes that participating in the trial is not in the best interest of the patient, or the investigator considers patient unsuitable for enrollment (such as unpredictable risks or subject compliance...
- Positive for coronavirus disease (COVID)-19 by PCR or evidence of active infection per local institutional standards.
- Allergy to iodine contrast or anesthesia
- For female people: Pregnant, nursing, or planning to become pregnant during the course of entire duration of the study (approximately little over two years) or unwillingness to comply with contraceptive requirements.
- For male people: Male people with a female partner who is planning to become pregnant with the male subject during the entire course of the study or unwillingness to comply with contraceptive requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.