Autologous SVF Therapy for Type 2 Diabetes

NCT07487467 · tracked via the Priya Life Science Brazil tracker

Sponsor

Kaiser Clinic and Hospital

Phase

Not applicable

Started

2025-01-20

Last updated

2026-03-23

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

Autologous Adipose-Derived Stromal Vascular Fraction (SVF)

Autologous Adipose-Derived Stromal Vascular Fraction (SVF): Autologous adipose tissue will be harvested using a 1210-nm diode laser-assisted liposuction technique (One-STEP™). The lipoaspirate will undergo double centrifugation without collagenase digestion to isolate stromal vascular fraction enriched with mesenchymal stem cells. The isolated SVF will be immediately injected into the duodenal submucosa during the same operative session.

Study summary

This prospective clinical study aims to evaluate the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF), enriched with mesenchymal stem cells (ADSCs), for the treatment of Type 2 Diabetes Mellitus (T2DM).

Adipose tissue will be harvested using a 1210-nm diode laser-assisted selective photochemical stimulation technique (One-STEP™ method), followed by centrifugation without enzymatic digestion. The isolated SVF will be injected endoluminally into the duodenal submucosa during the same surgical procedure.

Five adult patients with T2DM will be followed for six months to assess metabolic control, pancreatic function, and quality of life outcomes.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥ 18 years * Both sexes * Diagnosis of Type 2 Diabetes Mellitus for less than 10 years * BMI ≥ 25 kg/m² * HbA1c between 7.5% and 9.5% * C-peptide \> 1.0 nmol/L * Use of metformin and/or pioglitazone, with or without sulfonylurea Exclusion Criteria: * Type 1 Diabetes Mellitus or autoimmune diabetes * Positive anti-GAD antibodies * Pregnancy or breastfeeding * Use of insulin therapy * Use of SGLT2 inhibitors * Use of DPP-4 inhibitors * Use of GLP-1 receptor agonists * Unknown duration of diabetes

Primary outcome measure(s)

Change in Fasting Plasma Glucose (mg/dL) — Baseline and 6 months post-procedure
The primary outcome is the change in fasting plasma glucose levels (mg/dL) from baseline to 6 months after autologous stromal vascular fraction (SVF) injection into the duodenal submucosa. Fasting plasma glucose will be measured after an overnight fast of at least 8 hours.

Trial sites (1)

Facility	City	Region	Status
Kaiser Clinica	São Jose Do Rio Preto	São Paulo	Recruiting

More Kaiser Clinic and Hospital trials in Brazil

Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365 Recruiting

Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome Recruiting

Other trials for the same condition

Effect of Nutrition Education Groups in the Treatment of Patients with Type 2 Diabetes Recruiting

EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease Recruiting

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes Recruiting

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes Active, not recruiting

Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals With Type 2 Diabetes Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07487467 on ClinicalTrials.gov ↗ ← All trials in Brazil