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)

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 deficie...

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Main Authors: Barbara Soria-Juan, Mariano Garcia-Arranz, Lucía Llanos Jiménez, César Aparicio, Alejandro Gonzalez, Ignacio Mahillo Fernandez, Luis Riera del Moral, Lukasz Grochowicz, Enrique J. Andreu, Pedro Marin, Gregorio Castellanos, Jose Maria Moraleda, Ana Maria García-Hernández, Francisco S. Lozano, Fermin Sanchez-Guijo, Eva María Villarón, Miriam Lopez Parra, Rosa María Yañez, Antonio de la Cuesta Diaz, Juan Rigoberto Tejedo, Francisco J. Bedoya, Franz Martin, Manuel Miralles, Lourdes del Rio Sola, María Eugenia Fernández-Santos, José Manuel Ligero, Francisco Morant, Luis Hernández-Blasco, Etelvina Andreu, Abdelkrim Hmadcha, Damian Garcia-Olmo, Bernat Soria
Format: Article
Language:English
Published: BMC 2021-09-01
Series:Trials
Subjects:
Phase II clinical trial
Randomized
Adipose-derived mesenchymal stromal cells
Critical limb ischemia
Diabetes mellitus
Cell therapy
Online Access:https://doi.org/10.1186/s13063-021-05430-2

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