Diabetes Mellitus, Type 2
Conditions
Keywords
Adipose-Derived Stem Cells, Stromal Vascular Fraction, Mesenchymal Stem Cells, GLP-1, Regenerative Medicine
Brief 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.
Detailed description
Type 2 Diabetes Mellitus (T2DM) is a progressive metabolic disorder characterized by insulin resistance and beta-cell dysfunction. Current therapeutic approaches primarily aim to improve insulin sensitivity and glycemic control but do not restore pancreatic beta-cell function or incretin signaling. The duodenum plays a central role in metabolic signaling and insulin sensitivity regulation. Emerging evidence suggests that gastrointestinal mucosal modulation may improve glycemic control. Adipose-derived mesenchymal stem cells (ADSCs), obtained from stromal vascular fraction (SVF), have demonstrated immunomodulatory and regenerative properties. The One-STEP™ selective tissue engineering photostimulation technique (1210-nm diode laser) enables preservation of adipocytes and ADSCs without enzymatic digestion, maintaining high cell viability and surface marker expression. In this study, 40 mL of abdominal subcutaneous adipose tissue will be harvested using laser-assisted photochemical stimulation (Medilaser S 1210 nm). The lipoaspirate will undergo double centrifugation (800g and 700g) to isolate SVF without collagenase. The resulting pellet will be injected into the duodenal submucosa during the same procedure. Participants will be monitored for six months with metabolic and quality of life assessments.
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.
Sponsors
Kaiser Clinic and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, single-arm, open-label interventional feasibility study designed to evaluate the safety and preliminary efficacy of autologous adipose-derived stromal vascular fraction (SVF) enriched with mesenchymal stem cells in patients with Type 2 Diabetes Mellitus. All participants will undergo adipose tissue harvesting using a 1210-nm diode laser-assisted photochemical stimulation technique (One-STEP™ method), followed by same-procedure centrifugation and immediate endoluminal injection of SVF into the duodenal submucosa. Participants will be followed for six months to assess metabolic outcomes, pancreatic function, medication adjustment, and quality of life.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Contacts
CONTACTLuiz Gustavo' Quadros, PhD
Outcome results
None listed