Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925829
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2023-06-09
Brief Title:
Stromal Vascular Fraction and Autologous Activated Platelet-Rich Plasma Combination in Treating Treatment of Type 2 Diabetes
Sponsor:
Hayandra Peduli Foundation
Organization:
Hayandra Peduli Foundation
Study Overview
Official Title:
Stromal Vascular Fraction and Autologous Activated Platelet-Rich Plasma Combination in Treatment of Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 09 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 09 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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None