Autologous SVF Therapy for Type 2 Diabetes
ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaiser Clinic and Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Both sexes
Diagnosis of Type 2 Diabetes Mellitus for less than 10 years
BMI ≥ 25 kg/m²
Disqualifiers
Type 1 Diabetes Mellitus or autoimmune diabetes
Positive anti-GAD antibodies
Pregnancy or breastfeeding
Use of insulin therapy
Trial design
Design model
Single group
Treatments tested in this trial
Autologous Adipose-Derived Stromal Vascular Fraction (SVF)
Biological/VaccineAutologous 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Autologous SVF Duodenal InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Fasting Plasma Glucose (mg/dL)
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.
Time frame
Baseline and 6 months post-procedureLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Kaiser ClinicaRecruiting15.015-110, São Jose Do Rio Preto, São Paulo
Brazil
BrazilSponsors and contacts
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Source ClinicalTrials.gov