Stromal Vascular Fraction and Autologous Activated Platelet-Rich Plasma Combination in Treating Treatment of Type 2 Diabetes

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Platelet-rich Plasma; Stromal Vascular Fraction
• Interventions: Biological: SVF and aaPRP

• Registration Number: NCT05925829
• Lead Sponsor: Hayandra Peduli Foundation

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

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-22
• Last Update Submitted: 2023-06-22
• Study First Posted: 2023-06-29
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SVF and aaPRP treatment	SVF and aaPRP	Patients treated with SVF and aaPRP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hayandra Peduli Foundation; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia