Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol.
Elena de Celis-RuizBlanca FuentesFrancisco MonicheJoan MontanerAlberto M BorobiaMaria Gutiérrez-FernándezExuperio Díez-TejedorPublished in: BMJ open (2021)
This clinical trial has been approved by the Clinical Research Ethics Committee of La Paz University Hospital (Madrid, Spain) and by the Spanish Agency of Medication and Health Products and has been registered in Eudra CT (2019-001724-35) and ClinicalTrials.gov (NCT04280003). Study results will be disseminated through peer-reviewed publications in Open Access format and at conference presentations.
Keyphrases
- double blind
- clinical trial
- placebo controlled
- phase ii
- adipose tissue
- study protocol
- phase iii
- public health
- healthcare
- stem cell transplantation
- computed tomography
- open label
- randomized controlled trial
- minimally invasive
- insulin resistance
- bone marrow
- high dose
- risk assessment
- contrast enhanced
- phase ii study
- metabolic syndrome
- magnetic resonance imaging
- hematopoietic stem cell
- low dose
- skeletal muscle
- mental health
- health promotion
- dual energy
- adverse drug