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Completed

NCT Number: NCT05925829

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hayandra Peduli Foundation

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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

  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SVF and aaPRP

Biological

Stromal vascular fraction and autologous activated platelet-rich plasma

Primary outcomes

  1. Efficacy of SVF and aaPRP in Type 2 Diabetes Patients

    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

  2. Safety of SVF and aaPRP in Type 2 Diabetes Patients

    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.

Sponsors and collaborators

Lead sponsor

Hayandra Peduli Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2023
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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