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Autologous SVF Therapy for Type 2 Diabetes

RECRUITINGN/ASponsored by Kaiser Clinic and Hospital
Actively Recruiting
PhaseN/A
SponsorKaiser Clinic and Hospital
Started2025-01-20
Est. completion2026-03-16
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

DiabetesDiabetes Mellitus, Type 2

Interventions1

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