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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
SVF and aaPRP
Sponsored by
Hayandra Peduli Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring glycosylated hemoglobin A1c, platelet-rich plasma, stromal vascular fraction, type 2 diabetes mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hayandra Peduli Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SVF and aaPRP treatment

Arm Description

Patients treated with SVF and aaPRP

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
June 9, 2023
Last Updated
June 22, 2023
Sponsor
Hayandra Peduli Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05925829
Brief Title
Stromal Vascular Fraction and Autologous Activated Platelet-Rich Plasma Combination in Treating Treatment of Type 2 Diabetes
Official Title
Stromal Vascular Fraction and Autologous Activated Platelet-Rich Plasma Combination in Treatment of Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hayandra Peduli Foundation

4. Oversight

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Platelet-rich Plasma, Stromal Vascular Fraction
Keywords
glycosylated hemoglobin A1c, platelet-rich plasma, stromal vascular fraction, type 2 diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SVF and aaPRP treatment
Arm Type
Experimental
Arm Description
Patients treated with SVF and aaPRP
Intervention Type
Biological
Intervention Name(s)
SVF and aaPRP
Intervention Description
Stromal vascular fraction and autologous activated platelet-rich plasma
Primary Outcome Measure Information:
Title
Efficacy of SVF and aaPRP in Type 2 Diabetes Patients
Description
HbA1c level at baseline, 1-month, 3-month, 6-month, and 12-month post-treatment
Time Frame
Change of baseline HbA1c level at 1 month, 3 months, 6 months, and 12 months
Title
Safety of SVF and aaPRP in Type 2 Diabetes Patients
Description
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.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hayandra Peduli Foundation
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
HbA1c level at baseline, 1-month, 3-month, 6-month, and 12-month post-treatment Adverse events post-treatment

Learn more about this trial

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

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