Autologous SVF Therapy for Type 2 Diabetes

Conditions studied

Diabetes Mellitus, Type 2

About this study

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.

Interventions

• Biological: 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.

Primary outcomes

• Change in Fasting Plasma Glucose (mg/dL) (Baseline and 6 months post-procedure)

Eligibility information

Study locations

• Kaiser Clinica, São Jose Do Rio Preto, São Paulo 15.015-110 Brazil