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临床试验/NCT05925829
NCT05925829已完成1 期

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

Hayandra Peduli Foundation2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
39
试验地点
2
主要终点
Efficacy of SVF and aaPRP in Type 2 Diabetes Patients

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • patients who were pregnant
  • patients who were below 18 years of age
  • patients who were on insulin therapy.

结局指标

主要结局

Efficacy of SVF and aaPRP in Type 2 Diabetes Patients

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Hayandra Peduli Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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