RecruitingPhase 1Phase 2NCT05626712

Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes

Clinical Trial to Evaluate the Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes (CREATE-1)


Sponsor

Creative Medical Technology Holdings Inc

Enrollment

18 participants

Start Date

Apr 7, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy called CELZ-201 — made from special pancreatic stem cells — to see if it can help preserve the body's own insulin production in people who were recently diagnosed with type 1 diabetes. In type 1 diabetes, the immune system destroys the insulin-making beta cells in the pancreas. This therapy aims to protect and restore some of that function. **You may be eligible if...** - You are between 18 and 35 years old - You were diagnosed with type 1 diabetes within the past year - Your body is still producing some insulin (confirmed by a blood test called C-peptide) - You have at least two positive antibody markers for type 1 diabetes - Your blood sugar control and kidney function meet the required levels **You may NOT be eligible if...** - Your BMI is above 28, or your HbA1c is above 9% - You have a history of heart disease, liver disease, severe pancreatic problems, or a bleeding disorder - You have uncontrolled thyroid disease - You have poorly controlled high blood pressure - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCELZ-201 Administration

Participants in this group will receive a single dose of CELZ-201, in addition to standard of care for Type 1 Diabetes treatment. Perinatal tissue derived cells will be administered at a dose of 1x10\^6 cells/kg via an intra-arterial infusion into the dorsal pancreatic artery.

OTHERControl Group

Enhanced standard of care for Type 1 Diabetes treatment only.


Locations(1)

Diabetes Research Institute, University of Miami Miller School of Medicine

Miami, Florida, United States

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NCT05626712


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