Efficacy and safety of intramuscular administration of allogeneic adipose tissue derived and expanded mesenchymal stromal cells in diabetic patients with critical limb ischemia with no possibility of revascularization: study protocol for a randomized controlled double-blind phase II clinical trial (The NOMA Trial)

Autor: Alejandro Gonzalez, Franz Martín, Antonio de la Cuesta Diaz, Fermín Sánchez-Guijo, César Aparicio, Manuel Miralles, Eva Villarón, Miriam Lopez Parra, María Eugenia Fernández-Santos, Barbara Soria-Juan, José Manuel Ligero, Abdelkrim Hmadcha, Bernat Soria, José M. Moraleda, Francisco S. Lozano, Mariano Garcia-Arranz, Rosa Yañez, Pedro J. Marín, Luis Hernandez-Blasco, Ignacio Mahillo Fernández, Ana M García-Hernández, Francisco J. Bedoya, Enrique J. Andreu, Lourdes Del Rio Sola, Juan R. Tejedo, Etelvina Andreu, Lukasz Grochowicz, Gregorio Castellanos, Lucía Llanos Jiménez, Luis Riera del Moral, Damian Garcia-Olmo, Francisco Morant
Rok vydání: 2021
Předmět:
Medicine (General)
medicine.medical_specialty
medicine.medical_treatment
Randomized
Medicine (miscellaneous)
Noma
Revascularization
Cell therapy
Study Protocol
R5-920
Diabetes mellitus
Clinical Trials
Phase II as Topic
Double-Blind Method
Ischemia
Internal medicine
medicine
Animals
Humans
Multicenter Studies as Topic
Pharmacology (medical)
Therapeutic angiogenesis
Adverse effect
Randomized Controlled Trials as Topic
Advanced therapy medicinal products
SARS-CoV-2
business.industry
Adipose-derived mesenchymal stromal cells
Hematopoietic Stem Cell Transplantation
Critical limb ischemia
COVID-19
Type 2 Diabetes Mellitus
Mesenchymal Stem Cells
medicine.disease
Phase II clinical trial
Clinical trial
Treatment Outcome
Adipose Tissue
Diabetes Mellitus
Type 2
Quality of Life
medicine.symptom
business
Zdroj: Trials
Trials, Vol 22, Iss 1, Pp 1-12 (2021)
r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
instname
r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe
ISSN: 1745-6215
Popis: 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 ClinicalTrials.govNCT04466007. Registered on January 07, 2020. All items from the World Health Organization Trial Registration Data Set are included within the body of the protocol.
Databáze: OpenAIRE
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