Hayandra Peduli Foundation
Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia
NCT Number: NCT05925829
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stromal vascular fraction and autologous activated platelet-rich plasma
Time frame: Change of baseline HbA1c level at 1 month, 3 months, 6 months, and 12 months
HbA1c level at baseline, 1-month, 3-month, 6-month, and 12-month post-treatment
Time frame: Up to 12 months
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.
Hayandra Peduli Foundation
Other
Stromal Vascular Fraction and Autologous Activated Platelet-Rich Plasma Combination in Treatment of Type 2 Diabetes
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