[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630422":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":29,"overallOfficials":13,"centralContacts":37,"locations":43,"responsibleParty":52,"collaborators":13,"id":54,"slug":13,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":13,"enrollmentInfo":63,"targetDuration":13,"studyType":66,"phases":67,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":46,"whyStopped":13,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Kaiser Clinic and Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Fasting Plasma Glucose (mg\u002FdL)","The primary outcome is the change in fasting plasma glucose levels (mg\u002FdL) 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.","Baseline and 6 months post-procedure",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"NA","SINGLE_GROUP","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.","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","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.\n\nThe duodenum plays a central role in metabolic signaling and insulin sensitivity regulation. Emerging evidence suggests that gastrointestinal mucosal modulation may improve glycemic control.\n\nAdipose-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.\n\nIn 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.\n\nParticipants will be monitored for six months with metabolic and quality of life assessments.",[23],{"label":24,"type":25,"description":26,"interventionNames":27},"Autologous SVF Duodenal Injection","EXPERIMENTAL","Participants with Type 2 Diabetes Mellitus will undergo abdominal adipose tissue harvesting using a 1210-nm diode laser-assisted selective photochemical stimulation technique (One-STEP™ method). The lipoaspirate will be processed by centrifugation without enzymatic digestion to isolate stromal vascular fraction (SVF) enriched with mesenchymal stem cells. The isolated SVF will be injected into the duodenal submucosa during the same surgical procedure. Participants will be followed for six months to assess metabolic outcomes and safety.",[28],"Biological: Autologous Adipose-Derived Stromal Vascular Fraction (SVF)",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BIOLOGICAL","Autologous 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.",[24],[36],"SVFD DM2",[38],{"name":39,"role":40,"phone":41,"phoneExt":13,"email":42},"Luiz Gustavo' Quadros, PhD","CONTACT","+55 17 98138-8737","gustavo_quadros@hotmail.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":13,"geoPoint":13,"contacts":13},"Kaiser Clinica","RECRUITING","São Jose Do Rio Preto","São Paulo","15.015-110","Brazil","BR",{"type":53,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100630422",false,"NCT07487467","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","LASER-DM2 Tria","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Both sexes\n* Diagnosis of Type 2 Diabetes Mellitus for less than 10 years\n* BMI ≥ 25 kg\u002Fm²\n* HbA1c between 7.5% and 9.5%\n* C-peptide \\> 1.0 nmol\u002FL\n* Use of metformin and\u002For pioglitazone, with or without sulfonylurea\n\nExclusion Criteria:\n\n* Type 1 Diabetes Mellitus or autoimmune diabetes\n* Positive anti-GAD antibodies\n* Pregnancy or breastfeeding\n* Use of insulin therapy\n* Use of SGLT2 inhibitors\n* Use of DPP-4 inhibitors\n* Use of GLP-1 receptor agonists\n* Unknown duration of diabetes","ALL","18 Years",{"count":64,"type":65},10,"ESTIMATED","INTERVENTIONAL",[15],"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).\n\nAdipose 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.\n\nFive adult patients with T2DM will be followed for six months to assess metabolic control, pancreatic function, and quality of life outcomes.",[70],"Diabetes Mellitus, Type 2",[72,73,74,75,76],"Adipose-Derived Stem Cells","Stromal Vascular Fraction","Mesenchymal Stem Cells","GLP-1","Regenerative Medicine","2026-03-17",{"date":79,"type":80},"2026-03-23","ACTUAL",{"date":82,"type":80},"2025-01-20",{"date":84,"type":65},"2026-12-31",{"name":5,"class":6},1]