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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05925829
• Other study ID #: YHP005/Riset/2023
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: June 2023
• Source: Hayandra Peduli Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Platelet-rich Plasma

Intervention

Biological:
• SVF and aaPRP
Stromal vascular fraction and autologous activated platelet-rich plasma

Locations

Country	Name	City	State
Indonesia	Hayandra Peduli Foundation	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Hayandra Peduli Foundation

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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