RecruitingNot ApplicableNCT07487467

Autologous SVF Therapy for Type 2 Diabetes

Evaluation of Autologous Adipose-Derived Stromal Vascular Fraction Obtained by 1210-nm Laser Photostimulation for the Treatment of Type 2 Diabetes Mellitus

Sponsor

Kaiser Clinic and Hospital

Enrollment

10 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria8

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

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Interventions

BIOLOGICALAutologous 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.