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

NCT ID: NCT05925829

Last Updated: 2023-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-12-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Diabetes Mellitus, Type 2 Platelet-rich Plasma Stromal Vascular Fraction

Keywords

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glycosylated hemoglobin A1c platelet-rich plasma stromal vascular fraction type 2 diabetes mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SVF and aaPRP treatment

Patients treated with SVF and aaPRP

Group Type EXPERIMENTAL

SVF and aaPRP

Intervention Type BIOLOGICAL

Stromal vascular fraction and autologous activated platelet-rich plasma

Interventions

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SVF and aaPRP

Stromal vascular fraction and autologous activated platelet-rich plasma

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hayandra Peduli Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hayandra Peduli Foundation

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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YHP005/Riset/2023

Identifier Type: -

Identifier Source: org_study_id