首页> Trials> 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).

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).

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第一作者： Barbara,Soria-Juan

第一单位： Jimenez Diaz Foundation University Hospital, FJD Health Research Institute, IIS-FJD UAM, Madrid, Spain.

作者： Barbara,Soria-Juan ^[1] ; Mariano,Garcia-Arranz ^[1] ; Lucía,Llanos Jiménez ^[2] ; César,Aparicio ^[1] ; Alejandro,Gonzalez ^[1] ; Ignacio,Mahillo Fernandez ^[1] ; Luis,Riera Del Moral ^[3] ; Lukasz,Grochowicz ^[4] ; Enrique J,Andreu ^[4] ; Pedro,Marin ^[5] ; Gregorio,Castellanos ^[5] ; Jose Maria,Moraleda ^[5] ; Ana Maria,García-Hernández ^[5] ; Francisco S,Lozano ^[6] ; Fermin,Sanchez-Guijo ^[6] ; Eva María,Villarón ^[6] ; Miriam Lopez,Parra ^[6] ; Rosa María,Yañez ^[7] ; Antonio,de la Cuesta Diaz ^[8] ; Juan Rigoberto,Tejedo ^[9] ; Francisco J,Bedoya ^[10] ; Franz,Martin ^[9] ; Manuel,Miralles ^[11] ; Lourdes,Del Rio Sola ^[12] ; María Eugenia,Fernández-Santos ^[13] ; José Manuel,Ligero ^[13] ; Francisco,Morant ^[14] ; Luis,Hernández-Blasco ^[14] ; Etelvina,Andreu ^[15] ; Abdelkrim,Hmadcha ^[16] ; Damian,Garcia-Olmo ^[1] ; Bernat,Soria ^[17]

作者单位： Jimenez Diaz Foundation University Hospital, FJD Health Research Institute, IIS-FJD UAM, Madrid, Spain. ^[1] Jimenez Diaz Foundation University Hospital, FJD Health Research Institute, IIS-FJD UAM, Madrid, Spain. lucia.llanos@quironsalud.es. ^[2] La Paz University Hospital, Madrid, Spain. ^[3] Navarra University Clinic, Pamplona, Navarra, Spain. ^[4] Virgen de la Arrixaca University Hospital, Murcia, Spain. ^[5] IBSAL-University Hospital of Salamanca, University of Salamanca, Salamanca, Spain. ^[6] Hematopoietic Innovative Therapies Division, Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas (CIEMAT), Madrid, Spain. ^[7] Queen Victoria Eugenia-Cruz Roja Hospital, Sevilla, Spain. ^[8] University of Pablo de Olavide, Sevilla, Spain. ^[9] University of Pablo de Olavide, Sevilla, Spain.;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. ^[10] La Fe University Hospital, Valencia, Spain. ^[11] Valladolid Clinical University Hospital, Valladolid, Spain. ^[12] Institute for Health Research Gregorio Marañón (IISGM), General University Gregorio Marañón Hospital, Madrid, Spain. ^[13] Institute for Health Research-ISABIAL, General University Hospital, Alicante, Spain. ^[14] Institute for Health Research-ISABIAL, General University Hospital, Alicante, Spain.;University Miguel Hernández de Elche, Alicante, Spain. ^[15] University of Pablo de Olavide, Sevilla, Spain.;The Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders (CIBERDEM), Madrid, Spain.;University of Alicante, Alicante, Spain. ^[16] University of Pablo de Olavide, Sevilla, Spain.;Institute for Health Research-ISABIAL, General University Hospital, Alicante, Spain.;University Miguel Hernández de Elche, Alicante, Spain. ^[17]

关键词 Adipose-derived mesenchymal stromal cells Advanced therapy medicinal products Cell therapy Critical limb ischemia Diabetes mellitus Phase II clinical trial Randomized