Autologous SVF Therapy for Type 2 Diabetes

Официальное название

Evaluation of Autologous Adipose-Derived Stromal Vascular Fraction Obtained by 1210-nm Laser Photostimulation for the Treatment of Type 2 Diabetes Mellitus

Обзор

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.

Подробное описание

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.

The duodenum plays a central role in metabolic signaling and insulin sensitivity regulation. Emerging evidence suggests that gastrointestinal mucosal modulation may improve glycemic control.

Adipose-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.

In 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.

Participants will be monitored for six months with metabolic and quality of life assessments.

Вмешательства

• Биопрепарат 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.

Первичные конечные точки

• Change in Fasting Plasma Glucose (mg/dL) [Срок оценки: Baseline and 6 months post-procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Kaiser Clinica — São Jose Do Rio Preto

Публикации

• 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.
• Bhansali A, Asokumar P, Walia R, Bhansali S, Gupta V, Jain A, Sachdeva N, Sharma RR, Marwaha N, Khandelwal N. Efficacy and safety of autologous bone marrow-derived stem cell transplantation in patients with type 2 diabetes mellitus: a randomized placebo-controlled study. Cell Transplant. 2014;23(9):1075-85. doi: 10.3727/096368913X665576. PMID 23561959
• Zang L, Li Y, Hao H, Liu J, Cheng Y, Li B, Yin Y, Zhang Q, Gao F, Wang H, Gu S, Li J, Lin F, Zhu Y, Tian G, Chen Y, Gu W, Du J, Chen K, Guo Q, Yang G, Pei Y, Yan W, Wang X, Meng J, Zhang S, Ba J, Lyu Z, Dou J, Han W, Mu Y. Efficacy and safety of umbilical cord-derived mesenchymal stem cells in Chinese adults with type 2 diabetes: a single-center, double-blinded, randomized, placebo-controlled phas PMID 35505375
• Uccelli A, Moretta L, Pistoia V. Mesenchymal stem cells in health and disease. Nat Rev Immunol. 2008 Sep;8(9):726-36. doi: 10.1038/nri2395. PMID 19172693
• Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859. PMID 11304456

Идентификаторы

NCT: NCT07487467 · Stem Cells and DM2 · CAAE 69143523.9.0000.0281

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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