Actively Recruiting
Safety and Efficacy of OCN19-overexpressed Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Refractory Type 2 Diabetes Mellitus
Led by Lu jin ，MD · Updated on 2024-12-17
10
Participants Needed
1
Research Sites
318 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Efficacy of OCN19-overexpressed Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Refractory Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 2 diabetes based on WHO standards with fasting blood glucose of at least 7.0 mmol/L
- Age between 30 and 75 years, any gender
- Ability to understand the study and willingness to comply and sign informed consent
- Body Mass Index between 20 and 30 kg/m2
- Glycated hemoglobin between 7.5% and 10%
- Use of subcutaneous insulin injections for more than six months and stable use of insulin and/or metformin or glycosidase inhibitors for at least 3 months before randomization
- Willingness to use effective contraception during the study if of reproductive potential
You will not qualify if you...
- Type 1 diabetes, gestational diabetes, or other special diabetes types
- Severe allergies or allergies to any cell culture ingredients
- Use of drugs affecting glucose metabolism within the past month (e.g., glucocorticoids, thiazide diuretics, oral contraceptives, tricyclic antidepressants)
- Acute diabetic complications such as ketoacidosis or non-ketotic hyperosmolar syndrome within the last 6 months
- Serious cardiovascular or cerebrovascular events (e.g., NYHA III/IV heart failure, recent heart attack, stroke) within the last 6 months
- Abnormal blood counts or bleeding disorders
- Liver or kidney dysfunction beyond specified limits
- Serious systemic diseases including cancer or major organ system diseases
- Current use of systemic hormones, immunosuppressants, or cytotoxic therapy
- Antibiotic treatment within 3 months prior to enrollment
- Recent or planned live or attenuated vaccines
- Positive for hepatitis B surface antigen, hepatitis C antibody, HIV, or syphilis
- Active infections requiring treatment
- Fever of unknown origin
- Disability or mental illness affecting participation
- History of drug abuse or alcohol dependence within 5 years
- Pregnancy, lack of contraception, or breastfeeding
- Prior stem cell treatments or participation in clinical trials within 3 months
- Unrecovered adverse events from previous drug treatments
- Immune dysfunction or organ transplantation history
- Other serious diseases affecting treatment results
- Investigator judgment deeming patient unsuitable for the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China
Actively Recruiting
Research Team
J
jin lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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