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

NCT05925829 | Completed Phase 1

• 1 other identifier: YHP005/Riset/2023
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  Change of baseline HbA1c level at 1 month, 3 months, 6 months, and 12 months

• 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.

  Up to 12 months

Study Arms (1)

SVF and aaPRP treatment

EXPERIMENTAL

Patients treated with SVF and aaPRP

Biological: SVF and aaPRP

Interventions

SVF and aaPRP BIOLOGICAL

Stromal vascular fraction and autologous activated platelet-rich plasma

SVF and aaPRP treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hayandra Peduli Foundation: lead

Study Sites (1)

Hayandra Peduli Foundation

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 29, 2023
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)