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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The placebo group | Placebo Comparator | The control group was given albumin |
|
| The control group | Active Comparator | The control group was given mesenchymal stem cells |
|
| The experimental group | Experimental | The experimental group was given OCN-19 stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cells with OCN-19 | Biological | The patient received mesenchymal stem cells with OCN-19 three times |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily insulin dose is used | From enrollment to 1 month, 3 months, 6 months and 1 year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fasting Blood Glucose Levels Over Time | Fasting Blood Glucose (FBG) Definition: Blood sugar levels measured after fasting for at least 8 hours. Methods of measurement: Blood samples are determined using standardized laboratory analytical methods. Unit: Expressed in mg/dL (mg/dL). Time point: Measurements were taken at baseline, 12 and 24 weeks post-treatment. Goal: The target fasting blood glucose level in the study was <100 mg/dL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jin lu | Contact | 021-18801784133 | 18801784133@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | China |
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| Mesenchymal stem cells | Biological | Ordinary mesenchymal stem cells were given |
|
| albumin injection | Biological | Placebo |
|
| From enrollment to 1 month, 3 months, 6 months and 1 year after treatment |
| Concentration of Hemoglobin A1c in Participants | Definition: The proportion of hemoglobin bound to glucose that reflects average blood sugar levels over the past 2-3 months. Methods of measurement: Blood samples were analyzed using high performance liquid chromatography (HPLC). Unit: Expressed in percentage (%). Time point: Measurements were taken at baseline, 12 and 24 weeks post-treatment. Target: The target HbA1c level in the study was <7.0%. | From enrollment to 3 months, 6 months and 1 year after treatment |
| Concentration of fasting c-peptide in Participants | Definition: Clarify the definition of fasting C-peptide, which usually refers to the level of C-peptide measured in the fasting state, C-peptide is a by-product of insulin synthesis and reflects the function of islet beta cells. Measurement methods: Describe specific methods used to measure C-peptide, such as enzyme-linked immunosorbent assay (ELISA) . Units: Usually expressed in picmole/liter (pmol/L) or nanogram/milliliter (ng/mL). | From enrollment to 1 month, 3 months, 6 months and 1 year after treatment |
| Concentration of Glycated albumin in Participants | Definition: The proportion of albumin bound to glucose, reflecting the average blood sugar level over the past 2-3 weeks. Methods of measurement: Blood samples were analyzed using immunoassays. Unit: Expressed in percentage (%) | From enrollment to 1 month, 3 months, 6 months and 1 year after treatment |
| Concentration of 2-hour postprandial C-peptide in Participants | Definition: 2-hour postprandial C-peptide refers to the level of C-peptide measured 2 hours after eating, C-peptide is a by-product of insulin synthesis, reflecting the function of islet beta cells and insulin secretion capacity. Methods of measurement: Blood samples are analyzed using standardized methods such as enzyme-linked immunosorbent assay (ELISA) or radioimmunoassay (RIA). Units: Usually expressed in picomoles per liter (pmol/L) or nanograms per milliliter (ng/mL). | From enrollment to 1 month, 3 months, 6 months and 1 year after treatment |
| Concentration of total cholesterol in Participants | Definition: Total cholesterol is the sum of all cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and very low-density lipoprotein cholesterol (VLDL-C). Total cholesterol level is an important indicator of cardiovascular health. Methods of measurement: Blood samples are tested using standardized blood chemical analysis methods, usually enzymatic or chemical. Unit: Usually expressed in milligrams per deciliter (mg/dL). Target value: The normal range of total cholesterol in the study is usually: Ideal level: <200 mg/dL Marginal high levels: 200-239 mg/dL High level: ≥240 mg/dL | From enrollment to 1 month, 3 months, 6 months and 1 year after treatment |
| Concentration of LDL in Participants | Low Density Lipoprotein Cholesterol (LDL-C) Definition: Low-density lipoprotein cholesterol (LDL-C) is a major form of cholesterol transport in the blood and is often referred to as "bad cholesterol." High levels of LDL-C are associated with an increased risk of cardiovascular disease, atherosclerosis, and other cardiovascular events. Methods of measurement: Blood samples are tested using standardized blood chemical analysis methods, usually enzymatic or chemical. Unit: Usually expressed in milligrams per deciliter (mg/dL). Target values: The normal range of LDL-C in studies is usually: Ideal level: <100 mg/dL Near ideal/borderline high l | From enrollment to 1 month, 3 months, 6 months and 1 year after treatment |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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