PMID- 25304723
OWN - NLM
STAT- MEDLINE
DCOM- 20151117
LR  - 20200905
IS  - 1532-8511 (Electronic)
IS  - 1052-3057 (Linking)
VI  - 23
IP  - 10
DP  - 2014 Nov-Dec
TI  - Reparative therapy for acute ischemic stroke with allogeneic mesenchymal stem 
      cells from adipose tissue: a safety assessment: a phase II randomized, 
      double-blind, placebo-controlled, single-center, pilot clinical trial.
PG  - 2694-2700
LID - S1052-3057(14)00293-6 [pii]
LID - 10.1016/j.jstrokecerebrovasdis.2014.06.011 [doi]
AB  - BACKGROUND: Few studies have evaluated the possible beneficial effect of the 
      administration of stem cells in the early stages of stroke. Intravenous 
      administration of allogeneic mesenchymal stem cells (MSCs) from adipose tissue in 
      patients with acute stroke could be a safe therapy for promoting neurovascular 
      unit repair, consequently supporting better functional recovery. We aim to assess 
      the safety and efficacy of MSC administration and evaluate its potential as a 
      treatment for cerebral protection and repair. MATERIALS: A Phase IIa, 
      prospective, randomized, double-blind, placebo-controlled, single-center, pilot 
      clinical trial. Twenty patients presenting acute ischemic stroke will be 
      randomized in a 1:1 proportion to treatment with allogeneic MSCs from adipose 
      tissue or to placebo (or vehicle) administered as a single intravenous dose 
      within the first 2 weeks after the onset of stroke symptoms. The patients will be 
      followed up for 2 years. Primary outcomes for safety analysis: adverse events 
      (AEs) and serious AEs; neurologic and systemic complications, and tumor 
      development. Secondary outcomes for efficacy analysis: modified Rankin Scale; 
      NIHSS; infarct size; and biochemical markers of brain repair (vascular 
      endothelial growth factor, brain-derived neurotrophic factor, and matrix 
      metalloproteinases 9). RESULTS AND CONCLUSIONS: To our knowledge, this is the 
      first, phase II, pilot clinical trial to investigate the safety and efficacy of 
      intravenous administration of allogeneic MSCs from adipose tissue within the 
      first 2 weeks of stroke. In addition, its results will help us define the best 
      criteria for a future phase III study.
CI  - Copyright (c) 2014 National Stroke Association. Published by Elsevier Inc. All 
      rights reserved.
FAU - Diez-Tejedor, Exuperio
AU  - Diez-Tejedor E
AD  - Stroke Center, Department of Neurology, La Paz University Hospital, IdiPAZ Health 
      Research Institute, Universidad Autonoma de Madrid, Madrid, Spain. Electronic 
      address: exuperio.diez@salud.madrid.org.
FAU - Gutierrez-Fernandez, Maria
AU  - Gutierrez-Fernandez M
AD  - Stroke Center, Department of Neurology, La Paz University Hospital, IdiPAZ Health 
      Research Institute, Universidad Autonoma de Madrid, Madrid, Spain.
FAU - Martinez-Sanchez, Patricia
AU  - Martinez-Sanchez P
AD  - Stroke Center, Department of Neurology, La Paz University Hospital, IdiPAZ Health 
      Research Institute, Universidad Autonoma de Madrid, Madrid, Spain.
FAU - Rodriguez-Frutos, Berta
AU  - Rodriguez-Frutos B
AD  - Stroke Center, Department of Neurology, La Paz University Hospital, IdiPAZ Health 
      Research Institute, Universidad Autonoma de Madrid, Madrid, Spain.
FAU - Ruiz-Ares, Gerardo
AU  - Ruiz-Ares G
AD  - Stroke Center, Department of Neurology, La Paz University Hospital, IdiPAZ Health 
      Research Institute, Universidad Autonoma de Madrid, Madrid, Spain.
FAU - Lara, Manuel Lara
AU  - Lara ML
AD  - Stroke Center, Department of Neurology, La Paz University Hospital, IdiPAZ Health 
      Research Institute, Universidad Autonoma de Madrid, Madrid, Spain.
FAU - Gimeno, Blanca Fuentes
AU  - Gimeno BF
AD  - Stroke Center, Department of Neurology, La Paz University Hospital, IdiPAZ Health 
      Research Institute, Universidad Autonoma de Madrid, Madrid, Spain.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20141007
PL  - United States
TA  - J Stroke Cerebrovasc Dis
JT  - Journal of stroke and cerebrovascular diseases : the official journal of National 
      Stroke Association
JID - 9111633
RN  - 0 (Biomarkers)
RN  - 0 (Brain-Derived Neurotrophic Factor)
RN  - 0 (Vascular Endothelial Growth Factor A)
RN  - 0 (brain-derived growth factor)
RN  - EC 3.4.24.35 (Matrix Metalloproteinase 9)
SB  - IM
MH  - Adipose Tissue/*cytology
MH  - Aged
MH  - Aged, 80 and over
MH  - Biomarkers/blood
MH  - Brain Ischemia/blood/pathology/*therapy
MH  - Brain-Derived Neurotrophic Factor/blood
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Infarction/pathology
MH  - Infusions, Intravenous
MH  - Male
MH  - Matrix Metalloproteinase 9/blood
MH  - Mesenchymal Stem Cell Transplantation/*adverse effects/*methods
MH  - Mesenchymal Stem Cells/*cytology
MH  - Middle Aged
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Stroke/blood/pathology/*therapy
MH  - Time Factors
MH  - Transplantation, Homologous/methods
MH  - Treatment Outcome
MH  - Vascular Endothelial Growth Factor A/blood
OTO - NOTNLM
OT  - Acute ischemic stroke
OT  - clinical trial
OT  - reparative therapy
OT  - safety
OT  - stem cells
EDAT- 2014/10/12 06:00
MHDA- 2015/11/18 06:00
CRDT- 2014/10/12 06:00
PHST- 2014/02/05 00:00 [received]
PHST- 2014/05/12 00:00 [revised]
PHST- 2014/06/15 00:00 [accepted]
PHST- 2014/10/12 06:00 [entrez]
PHST- 2014/10/12 06:00 [pubmed]
PHST- 2015/11/18 06:00 [medline]
AID - S1052-3057(14)00293-6 [pii]
AID - 10.1016/j.jstrokecerebrovasdis.2014.06.011 [doi]
PST - ppublish
SO  - J Stroke Cerebrovasc Dis. 2014 Nov-Dec;23(10):2694-2700. doi: 
      10.1016/j.jstrokecerebrovasdis.2014.06.011. Epub 2014 Oct 7.