RecruitingPhase 2NCT06727721

Safety and Efficacy of OCN19-overexpressed Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Refractory Type 2 Diabetes Mellitus


Sponsor

Lu jin ,MD

Enrollment

10 participants

Start Date

Nov 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Umbilical cord mesenchymal stem cell injection expressing OCN19, while playing the role of MSCs, can directly stimulate the expression of insulin gene and the division and proliferation of islet beta cells, which is expected to further enhance the therapeutic effect of stem cells. In non-clinical studies, it was found that MSCs expressing OCN19 had better hypoglycemic effect than MSCs


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special type of stem cell therapy — using umbilical cord stem cells engineered to produce a protein called OCN19 — can help people with type 2 diabetes that hasn't responded well to standard medications. **You may be eligible if...** - You are 30 to 75 years old with confirmed type 2 diabetes (fasting blood sugar ≥ 7.0 mmol/L) - Your HbA1c (3-month blood sugar average) is between 7.5% and 10% - Your BMI is between 20 and 30 - You have been on insulin injections for at least 6 months, with a stable dose for the last 3 months - You are willing to use effective contraception during the study **You may NOT be eligible if...** - You have type 1 diabetes, gestational diabetes, or another special type of diabetes - You have severe allergies or known allergy to any component of the cell culture - You have had a serious heart attack, stroke, or heart failure in the past 6 months - You have significant liver or kidney disease - You have an active infection, cancer, or immune system disorder - You are pregnant, breastfeeding, or planning pregnancy - You have received other stem cell treatments in the past 3 months 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

BIOLOGICALmesenchymal stem cells with OCN-19

The patient received mesenchymal stem cells with OCN-19 three times

BIOLOGICALMesenchymal stem cells

Ordinary mesenchymal stem cells were given

BIOLOGICALalbumin injection

Placebo


Locations(1)

Changhai Hospital

Shanghai, China

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NCT06727721


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