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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).
Soria-Juan, Barbara; Garcia-Arranz, Mariano; Llanos Jiménez, Lucía; Aparicio, César; Gonzalez, Alejandro; Mahillo Fernandez, Ignacio; Riera Del Moral, Luis; Grochowicz, Lukasz; Andreu, Enrique J; Marin, Pedro; Castellanos, Gregorio; Moraleda, Jose Maria; García-Hernández, Ana Maria; Lozano, Francisco S; Sanchez-Guijo, Fermin; Villarón, Eva María; Parra, Miriam Lopez; Yañez, Rosa María; de la Cuesta Diaz, Antonio; Tejedo, Juan Rigoberto; Bedoya, Francisco J; Martin, Franz; Miralles, Manuel; Del Rio Sola, Lourdes; Fernández-Santos, María Eugenia; Ligero, José Manuel; Morant, Francisco; Hernández-Blasco, Luis; Andreu, Etelvina; Hmadcha, Abdelkrim; Garcia-Olmo, Damian; Soria, Bernat.
  • Soria-Juan B; Jimenez Diaz Foundation University Hospital, FJD Health Research Institute, IIS-FJD UAM, Madrid, Spain.
  • Garcia-Arranz M; Jimenez Diaz Foundation University Hospital, FJD Health Research Institute, IIS-FJD UAM, Madrid, Spain.
  • Llanos Jiménez L; Jimenez Diaz Foundation University Hospital, FJD Health Research Institute, IIS-FJD UAM, Madrid, Spain. lucia.llanos@quironsalud.es.
  • Aparicio C; Jimenez Diaz Foundation University Hospital, FJD Health Research Institute, IIS-FJD UAM, Madrid, Spain.
  • Gonzalez A; Jimenez Diaz Foundation University Hospital, FJD Health Research Institute, IIS-FJD UAM, Madrid, Spain.
  • Mahillo Fernandez I; Jimenez Diaz Foundation University Hospital, FJD Health Research Institute, IIS-FJD UAM, Madrid, Spain.
  • Riera Del Moral L; La Paz University Hospital, Madrid, Spain.
  • Grochowicz L; Navarra University Clinic, Pamplona, Navarra, Spain.
  • Andreu EJ; Navarra University Clinic, Pamplona, Navarra, Spain.
  • Marin P; Virgen de la Arrixaca University Hospital, Murcia, Spain.
  • Castellanos G; Virgen de la Arrixaca University Hospital, Murcia, Spain.
  • Moraleda JM; Virgen de la Arrixaca University Hospital, Murcia, Spain.
  • García-Hernández AM; Virgen de la Arrixaca University Hospital, Murcia, Spain.
  • Lozano FS; IBSAL-University Hospital of Salamanca, University of Salamanca, Salamanca, Spain.
  • Sanchez-Guijo F; IBSAL-University Hospital of Salamanca, University of Salamanca, Salamanca, Spain.
  • Villarón EM; IBSAL-University Hospital of Salamanca, University of Salamanca, Salamanca, Spain.
  • Parra ML; IBSAL-University Hospital of Salamanca, University of Salamanca, Salamanca, Spain.
  • Yañez RM; Hematopoietic Innovative Therapies Division, Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas (CIEMAT), Madrid, Spain.
  • de la Cuesta Diaz A; Queen Victoria Eugenia-Cruz Roja Hospital, Sevilla, Spain.
  • Tejedo JR; University of Pablo de Olavide, Sevilla, Spain.
  • Bedoya FJ; University of Pablo de Olavide, Sevilla, Spain.
  • Martin F; Network Center for Research in Diabetes and Associated Metabolic Diseases (Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas-CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain.
  • Miralles M; University of Pablo de Olavide, Sevilla, Spain.
  • Del Rio Sola L; La Fe University Hospital, Valencia, Spain.
  • Fernández-Santos ME; Valladolid Clinical University Hospital, Valladolid, Spain.
  • Ligero JM; Institute for Health Research Gregorio Marañón (IISGM), General University Gregorio Marañón Hospital, Madrid, Spain.
  • Morant F; Institute for Health Research Gregorio Marañón (IISGM), General University Gregorio Marañón Hospital, Madrid, Spain.
  • Hernández-Blasco L; Institute for Health Research-ISABIAL, General University Hospital, Alicante, Spain.
  • Andreu E; Institute for Health Research-ISABIAL, General University Hospital, Alicante, Spain.
  • Hmadcha A; Institute for Health Research-ISABIAL, General University Hospital, Alicante, Spain.
  • Garcia-Olmo D; University Miguel Hernández de Elche, Alicante, Spain.
  • Soria B; University of Pablo de Olavide, Sevilla, Spain.
Trials ; 22(1): 595, 2021 Sep 06.
Article in English | MEDLINE | ID: covidwho-1398873
ABSTRACT

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 111 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.gov 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.
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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Hematopoietic Stem Cell Transplantation / Diabetes Mellitus, Type 2 / Mesenchymal Stem Cells / COVID-19 / Noma Subject: Hematopoietic Stem Cell Transplantation / Diabetes Mellitus, Type 2 / Mesenchymal Stem Cells / COVID-19 / Noma Type of study: Controlled clinical trial / Diagnostic study / Clinical Practice Guide / Observational study / Patient-preference / Prognostic study Language: English Journal: Trials Clinical aspect: Therapy Year: 2021

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Hematopoietic Stem Cell Transplantation / Diabetes Mellitus, Type 2 / Mesenchymal Stem Cells / COVID-19 / Noma Subject: Hematopoietic Stem Cell Transplantation / Diabetes Mellitus, Type 2 / Mesenchymal Stem Cells / COVID-19 / Noma Type of study: Controlled clinical trial / Diagnostic study / Clinical Practice Guide / Observational study / Patient-preference / Prognostic study Language: English Journal: Trials Clinical aspect: Therapy Year: 2021
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