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Trials ; 22(1): 595, 2021 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-34488845


BACKGROUND: Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatment, based on antiplatelet therapy and statins, has demonstrated deficient improvement of the disease. In recent years, research has shown that it is possible to improve tissue perfusion through therapeutic angiogenesis. Both in animal models and humans, it has been shown that cell therapy can induce therapeutic angiogenesis, making mesenchymal stromal cell-based therapy one of the most promising therapeutic alternatives. The aim of this study is to evaluate the feasibility, safety, and efficacy of cell therapy based on mesenchymal stromal cells derived from adipose tissue intramuscular administration to patients with type 2 diabetes mellitus with critical limb ischemia and without possibility of revascularization. METHODS: A multicenter, randomized double-blind, placebo-controlled trial has been designed. Ninety eligible patients will be randomly assigned at a ratio 1:1:1 to one of the following: control group (n = 30), low-cell dose treatment group (n = 30), and high-cell dose treatment group (n = 30). Treatment will be administered in a single-dose way and patients will be followed for 12 months. Primary outcome (safety) will be evaluated by measuring the rate of adverse events within the study period. Secondary outcomes (efficacy) will be measured by assessing clinical, analytical, and imaging-test parameters. Tertiary outcome (quality of life) will be evaluated with SF-12 and VascuQol-6 scales. DISCUSSION: Chronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future. TRIAL REGISTRATION: NCT04466007 . Registered on January 07, 2020. All items from the World Health Organization Trial Registration Data Set are included within the body of the protocol.

COVID-19 , Diabetes Mellitus Tipo 2 , Transplante de Células-Tronco Hematopoéticas , Células-Tronco Mesenquimais , Noma , Tecido Adiposo , Animais , Ensaios Clínicos Fase II como Assunto , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/terapia , Método Duplo-Cego , Humanos , Isquemia/diagnóstico , Isquemia/terapia , Estudos Multicêntricos como Assunto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Resultado do Tratamento
Front Immunol ; 10: 1151, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31231366


Cell therapy is a progressively growing field that is rapidly moving from preclinical model development to clinical application. Outcomes obtained from clinical trials reveal the therapeutic potential of stem cell-based therapy to deal with unmet medical treatment needs for several disorders with no therapeutic options. Among adult stem cells, mesenchymal stem cells (MSCs) are the leading cell type used in advanced therapies for the treatment of autoimmune, inflammatory and vascular diseases. To date, the safety and feasibility of autologous MSC-based therapy has been established; however, their indiscriminate use has resulted in mixed outcomes in preclinical and clinical studies. While MSCs derived from diverse tissues share common properties depending on the type of clinical application, they markedly differ within clinical trials in terms of efficacy, resulting in many unanswered questions regarding the application of MSCs. Additionally, our experience in clinical trials related to critical limb ischemia pathology (CLI) shows that the therapeutic efficacy of these cells in different animal models has only been partially reproduced in humans through clinical trials. Therefore, it is crucial to develop new research to identify pitfalls, to optimize procedures and to clarify the repair mechanisms used by these cells, as well as to be able to offer a next generation of stem cell that can be routinely used in a cost-effective and safe manner in stem cell-based therapies targeting CLI.

Ann Vasc Surg ; 28(4): 999-1004, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24559786


BACKGROUND: The aim of this study was to investigate the utility of admission neutrophil-lymphocyte ratio (NLR) in predicting the amputation-free survival (AFS) of patients with critical limb ischemia (CLI) who underwent an elective infrainguinal therapeutic intervention. METHODS: All patients with CLI undergoing elective infrainguinal vascular surgery (open or endovascular) at a single university teaching hospital between January 2005 and December 2009 were retrospectively identified from a prospectively maintained database. The primary end point was AFS. The cut-off of NLR >5 was used to categorize patients into low- and high-NLR groups. Kaplan-Meier analysis and long-rank test were used to compare survival between both groups. Cox regression analysis was conducted to determine independent factors affecting the AFS. RESULTS: During a median follow-up of 31 months, 561 patients with chronic CLI underwent infrainguinal revascularization. Five-year mortality was lower in the NLR <5 group (33%) than in the NLR >5 group (49%) (P ≤ 0.001), and the AFS was significantly higher in the NLR <5 group (50%) than in the NLR >5 group (26%) (P ≤ 0.001). In a multivariate analysis, preoperative NLR >5 was independently associated with 5-year AFS (hazard ratio 2.325, 95% CI 1.732-3.121). CONCLUSIONS: Elevated NLR predicts a worse AFS in patients undergoing infrainguinal vascular revascularization with chronic CLI, suggesting that the NLR conveys powerful prognostic information that is independent of other conventional clinical risk factors.

Amputação , Procedimentos Endovasculares , Isquemia/sangue , Salvamento de Membro , Linfócitos , Neutrófilos , Doença Arterial Periférica/sangue , Doença Arterial Periférica/terapia , Procedimentos Cirúrgicos Vasculares , Adulto , Idoso , Idoso de 80 Anos ou mais , Distribuição de Qui-Quadrado , Doença Crônica , Estado Terminal , Intervalo Livre de Doença , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Hospitais Universitários , Humanos , Isquemia/diagnóstico , Isquemia/mortalidade , Isquemia/terapia , Estimativa de Kaplan-Meier , Contagem de Linfócitos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Espanha , Fatores de Tempo , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/mortalidade