Using your own fat-derived cells injected into the duodenum to help control 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
This study will try injecting a person's own fat-derived cell mix into the duodenal lining to see if it improves blood sugar control in adults with type 2 diabetes who are not using insulin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kaiser Clinic and Hospital Academic / other |
| Locations | 1 site (São Jose Do Rio Preto, São Paulo) |
| Trial ID | NCT07487467 on ClinicalTrials.gov |
What this trial studies
About 40 mL of abdominal fat will be harvested using a 1210-nm diode laser One-STEP technique, and the stromal vascular fraction (SVF) will be isolated by double centrifugation without enzymatic digestion. The autologous SVF, which contains adipose-derived mesenchymal stem cells and supporting cells, will be injected into the duodenal submucosa during the same procedure. Five adults with type 2 diabetes meeting entry criteria will be followed for six months with metabolic testing, measures of pancreatic function (including C-peptide), and quality-of-life assessments. The trial is small and primarily designed to provide preliminary safety, feasibility, and early efficacy signals of this regenerative approach.
Who should consider this trial
Good fit: Adults (≥18 years) with type 2 diabetes diagnosed less than 10 years ago, BMI ≥25 kg/m², HbA1c between 7.5% and 9.5%, C-peptide >1.0 nmol/L, and treated with metformin and/or pioglitazone (with or without sulfonylurea) are ideal candidates.
Not a fit: People with type 1 or autoimmune diabetes, positive anti-GAD antibodies, those on insulin or GLP-1/SGLT2/DPP-4 therapies, pregnant or breastfeeding individuals, or those with long-standing/advanced disease are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the procedure could improve blood sugar control and possibly support pancreatic beta-cell function using the patient's own cells.
How similar studies have performed: Early preclinical work and small clinical reports of adipose-derived mesenchymal stem cells show some promising metabolic effects, but direct injection of SVF into the duodenal submucosa is novel and lacks larger confirmatory trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
São Jose Do Rio Preto, São Paulo
- Kaiser Clinica — São Jose Do Rio Preto, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Luiz Gustavo' Quadros, PhD
- Email: gustavo_quadros@hotmail.com
- Phone: +55 17 98138-8737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.