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).
Barbara Soria-JuanMariano Garcia-ArranzLucía Llanos JiménezCésar AparicioAlejandro GonzalezIgnacio Mahillo FernandezLuis Riera Del MoralLukasz GrochowiczEnrique J AndreuPedro MarinGregorio CastellanosJose Maria MoraledaAna Maria García-HernándezFrancisco S LozanoFermin Sanchez-GuijoEva María VillarónMiriam Lopez ParraRosa María YañezAntonio de la Cuesta DiazJuan Rigoberto TejedoFrancisco J BedoyaFranz MartinManuel MirallesLourdes Del Rio SolaMaría Eugenia Fernández-SantosJosé Manuel LigeroFrancisco MorantLuis Hernández-BlascoEtelvina AndreuAbdelkrim HmadchaDamian Garcia-OlmoBernat SoriaPublished in: Trials (2021)
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.
Keyphrases
- phase ii
- clinical trial
- double blind
- phase iii
- open label
- placebo controlled
- adipose tissue
- bone marrow
- stem cell transplantation
- type diabetes
- randomized controlled trial
- electronic health record
- percutaneous coronary intervention
- high fat diet
- insulin resistance
- wound healing
- acute coronary syndrome
- metabolic syndrome
- coronary artery bypass grafting
- low dose
- high dose
- skeletal muscle
- atrial fibrillation
- data analysis