Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 10:42 AM
Study NCT ID:
NCT07487467
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous SVF Therapy for Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Fasting Plasma Glucose (mg/dL)', 'timeFrame': 'Baseline and 6 months post-procedure', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adipose-Derived Stem Cells', 'Stromal Vascular Fraction', 'Mesenchymal Stem Cells', 'GLP-1', 'Regenerative Medicine'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Centurion P, Gamarra R, Caballero G, et al. Optimizing harvesting for facial lipografting with a new photochemical stimulation concept: One STEP technique™. Eur J Plast Surg. 2020;43(6):733-742.'}, {'type': 'BACKGROUND', 'citation': 'Bhansali A, Asokumar P, Walia R, et al. Efficacy and safety of autologous bone marrow-derived stem cell transplantation in patients with type 2 diabetes mellitus: randomized placebo-controlled study. Cell Transplant. 2014;23(9):1075-1085.'}, {'type': 'BACKGROUND', 'citation': 'Zang L, Li Y, Hao H, et al. Efficacy and safety of umbilical cord-derived mesenchymal stem cells in adults with type 2 diabetes: randomized placebo-controlled phase II trial. Stem Cell Res Ther. 2022;13:180.'}, {'type': 'BACKGROUND', 'citation': 'Uccelli A, Moretta L, Pistoia V. Mesenchymal stem cells in health and disease. Nat Rev Immunol. 2008;8(9):726-736.'}, {'type': 'BACKGROUND', 'citation': 'Zuk PA, Zhu M, Mizuno H, et al. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001;7(2):211-228.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/m²\n* HbA1c between 7.5% and 9.5%\n* C-peptide \\> 1.0 nmol/L\n* Use of metformin and/or 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'}, 'identificationModule': {'nctId': 'NCT07487467', 'acronym': 'LASER-DM2 Tria', 'briefTitle': 'Autologous SVF Therapy for Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Clinic and Hospital'}, 'officialTitle': 'Evaluation of Autologous Adipose-Derived Stromal Vascular Fraction Obtained by 1210-nm Laser Photostimulation for the Treatment of Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'Stem Cells and DM2'}, 'secondaryIdInfos': [{'id': 'CAAE 69143523.9.0000.0281', 'type': 'OTHER', 'domain': 'CEP KAISER CLÍNICA & HOSPITAL DIA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autologous SVF Duodenal Injection', 'description': '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.', 'interventionNames': ['Biological: Autologous Adipose-Derived Stromal Vascular Fraction (SVF)']}], 'interventions': [{'name': 'Autologous Adipose-Derived Stromal Vascular Fraction (SVF)', 'type': 'BIOLOGICAL', 'otherNames': ['SVFD DM2'], 'description': '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.', 'armGroupLabels': ['Autologous SVF Duodenal Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15.015-110', 'city': 'São Jose Do Rio Preto', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Kaiser Clinica'}], 'centralContacts': [{'name': "Luiz Gustavo' Quadros, PhD", 'role': 'CONTACT', 'email': 'gustavo_quadros@hotmail.com', 'phone': '+55 17 98138-8737'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The decision regarding individual participant data (IPD) sharing has not yet been finalized. Given the small sample size and the need to ensure participant confidentiality, data sharing policies will be defined after study completion in accordance with institutional regulations and applicable data protection laws.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Clinic and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}