Is NCT05626712 recruiting in Miami, FL?

Yes, NCT05626712 is currently recruiting participants at its Miami, FL location. This type 1 diabetes clinical trial is actively enrolling qualified participants.

How do I join the type 1 diabetes clinical trial in Miami?

To join this clinical trial in Miami, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Miami clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Type 1 Diabetes Clinical Trial in Miami, FL

Who Can Participate

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 ZnT8.

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.

Adequate venous access to support study required blood draws.

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

Ongoing acute infections, e.g., acute respiratory tract, urinary tract, or gastrointestinal tract infections.

Subjects 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 to heparin, will be excluded.

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 issues).

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 subjects: 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 subjects: Male subjects 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT05626712) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Type 1 Diabetes Treatment Options in Miami, FL

If you're searching for type 1 diabetes treatment options in Miami, FL, this clinical trial (NCT05626712) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced type 1 diabetes specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all type 1 diabetes clinical trials near you to find additional studies recruiting in your area.

Type 1 Diabetes Clinical Trial in Miami, FL

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About This Type 1 Diabetes Study in Miami