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Cell injury in human islets induced by non-immune mediated inflammation occur in vitro upon hyperglycemia in type 2 diabetes mellitus. Infusion of autologous bone marrow mononuclear cells (MCs) is an emerging therapeutic approach for DM, which showed promising outcomes with mild side effects. Infusion of MCs and autologous bone marrow mesenchymal stem cells in combination might exert enhanced repairing effects. We hypothesized that infusion of these two classes of cells might provide multiple signals for regeneration and improve recovery from inflammation-induced lesion. The effects might be maximized by intra-arterial pancreatic infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC+MC | Experimental | infusion of BMMSC+BMMNC and insulin injection |
|
| MC | Active Comparator | infusion of BMMNC and insulin injection |
|
| Insulin | Active Comparator | insulin injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infusion of MSCs | Drug | infusion of MSCs |
| |
| infusion MCs |
| Measure | Description | Time Frame |
|---|---|---|
| macrovascular complications | 8 years | |
| microvascular complications | 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| DPN | diabetes peripheral neuropathy | 8 years |
| MI | myocardial infarction | 8 years |
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Inclusion Criteria:
Insulin dose and metformin doses should be stable over the 3 months prior to randomization.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou General Hospital, Xiamen Univ | Fuzhou | Fujian | 350025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39350270 | Derived | Wu Z, Huang S, Li S, Cai J, Huang L, Wu W, Chen J, Tan J. Bone marrow mesenchymal stem cell and mononuclear cell combination therapy in patients with type 2 diabetes mellitus: a randomized controlled study with 8-year follow-up. Stem Cell Res Ther. 2024 Sep 30;15(1):339. doi: 10.1186/s13287-024-03907-w. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
infusion of MCs |
|
| insulin | Drug | intensive insulin care |
|
| angina | angina | 8 years |
| stroke | stroke | 8 years |
| amputation | amputation | 8 years |
| DN | diabetes nephropathy | 8 years |
| DRP | diabetes retinopathy | 8 years |
| pro-DRP | proliferative diabetes retinopathy | 8 years |
| C-peptide AUC | C-peptide area under the curve | 1y |
| insulin AUC | insulin area under the curve | 1y |
| HbA1c | glycated hemoglobin | 1y |
| FBG | fasting hemoglucose | 1y |
| insuline dose | exogenous insulin requirements | 1y |
| fasting C-p | fasting c-peptide | 1y |
| The incidence and severity of adverse events related to the stem cell infusion procedure | 8y |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |