Diabetes Mellitus, Type 2, Platelet-rich Plasma, Stromal Vascular Fraction
Conditions
Keywords
glycosylated hemoglobin A1c, platelet-rich plasma, stromal vascular fraction, type 2 diabetes mellitus
Brief summary
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.
Detailed description
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: 1. Patients who were diagnosed with type 2 diabetes (T2D) for at least 2 years with the diagnosis of T2D and treatment with oral anti-hyperglycemic therapy with metformin were in accordance with the guideline for management and prevention of T2D by the Indonesian Society of Endocrinology. 2. Patients who have undergone standard oral anti-hyperglycemic therapy with metformin and had not been able to reach normal HbA1c level with the medication 3. Patients who underwent autologous SVF-aaPRP therapy between January until December 2017 Exclusion criteria 1. Patients who were pregnant 2. Patients who were below 18 years of age 3. Patients who were on insulin therapy
Interventions
BIOLOGICALSVF and aaPRP
Stromal vascular fraction and autologous activated platelet-rich plasma
Sponsors
Hayandra Peduli Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who were diagnosed with T2D for at least 2 years * patients who have undergone standard oral anti-hyperglycemic therapy with metformin and had not been able to reach normal HbA1c level with the medication * patients who underwent autologous SVF-aaPRP therapy between January until December 2017
Exclusion criteria
* patients who were pregnant * patients who were below 18 years of age * patients who were on insulin therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of SVF and aaPRP in Type 2 Diabetes Patients | 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 |
| Safety of SVF and aaPRP in Type 2 Diabetes Patients | 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. |
Countries
Indonesia
Outcome results
None listed