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This study was a retrospective study on type 2 diabetes patients that were treated with autologous stromal vascular fraction (SVF) and autologous activated platelet-rich plasma (aaPRP) measuring HbA1c level at baseline, 1-month, 3-month, 6-month, and 12-month post-treatment.
The preparation of SVF used the H-Remedy (Jakarta, Indonesia) method invented by HayandraLab. Manual liposuction was performed to collect the lipoaspirate. The aaPRP was prepared using an in-house method of HayandraLab. The SVF pellet was resuspended in 0.9% normal saline, resulting in a total of 22 mL SVF suspension. 7 mL of cell suspension was used for quality control. A total of 15 mL SVF suspension was mixed with 3 mL aaPRP. A total of 20 mL of SVF and aaPRP suspension was injected into an infusion bag which contained 250 ml of 0.9% normal saline. The mixture of SVF and aaPRP was then infused intravenously to each patient for a duration of around 30 minutes. The infusion was given on the day of the patient's lipoaspiration procedure. The patients underwent three subsequent infusions of SVF and aaPRP combination, followed by four aaPRP infusions. These therapy sessions were scheduled with a 2-weeks interval.
Inclusion criteria:
Exclusion criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SVF and aaPRP treatment | Experimental | Patients treated with SVF and aaPRP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SVF and aaPRP | Biological | Stromal vascular fraction and autologous activated platelet-rich plasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of SVF and aaPRP in Type 2 Diabetes Patients | HbA1c level at baseline, 1-month, 3-month, 6-month, and 12-month post-treatment | Change of baseline HbA1c level at 1 month, 3 months, 6 months, and 12 months |
| Safety of SVF and aaPRP in Type 2 Diabetes Patients | Adverse events related with SVF and aaPRP treatment such as hematoma, infection, profuse bleeding, vessel puncture, intravascular administration of the cell preparation with potential phlebitis and/or distal embolism. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hayandra Peduli Foundation | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
HbA1c level at baseline, 1-month, 3-month, 6-month, and 12-month post-treatment Adverse events post-treatment
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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 |
| D004700 | Endocrine System Diseases |
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