Safety of cell therapy with Mesenchymal Stromal Cells (MSCs): A systematic review

  • M.M. L
  • L. M
  • C. P
 et al. 
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Abstract

BACKGROUND: Recent preclinical studies suggest that mesenchymal stromal cells (MSCs) may markedly improve outcome from critical illness, specifically septic shock and acute respiratory distress syndrome. Before considering a human clinical trial of MSC immunomodulatory cell therapy for the critically ill, we performed a systematic review of all clinical studies to examine the safety of MSCs in adults. We focused on serious adverse events that could affect the cardiovascular, pulmonary, renal, neurological, and hematological systems. METHODS: Electronic databases were searched from 1950 to 2009 (MEDLINE, EMBASE, Cochrane Central Registry of Controlled Trials); conference proceedings and grey literature were also searched from 2004 to 2009. All prospective clinical trials (randomized controlled trials (RCT), prospective cohort studies, and case series) that examined safety of MSCs in adult populations were identified. Only trials that exclusively used MSCs with no other concomitant experimental therapy were included. No restrictions were placed for language or publication type. RESULTS: Of the 1885 citations reviewed, 24 studies were included. A total of 652 patients with conditions including ischemic stroke, spinal cord injury, Crohn's disease, cardiomyopathy, myocardial infarction, graft versus host disease, and healthy volunteers were included. Eleven studies included a control group for comparison (191 MSC treated patients, 250 control) ten were RCTs. No study stopped MSCs administration due to immediate adverse reactions. Of eleven trials with a control group, death was reported in five and was less frequent in the MSC as compared to the control group (7/102 (6.8%) vs. 20/112 (17.8%), p

Author-supplied keywords

  • Crohn disease
  • Medline
  • adult
  • adult respiratory distress syndrome
  • adverse drug reaction
  • brain
  • brain ischemia
  • cardiomyopathy
  • carotid artery
  • case study
  • cell therapy
  • clinical study
  • clinical trial
  • clinical trial (topic)
  • cohort analysis
  • computer assisted tomography
  • control group
  • controlled study
  • critical illness
  • critically ill patient
  • data base
  • death
  • embolism
  • experimental therapy
  • fever
  • follow up
  • graft versus host reaction
  • heart arrhythmia
  • heart infarction
  • human
  • injection
  • intraarterial drug administration
  • intrathecal drug administration
  • kidney failure
  • language
  • lung edema
  • mesenchymal stroma cell
  • normal human
  • patient
  • population
  • pulmonary hypertension
  • randomized controlled trial (topic)
  • register
  • safety
  • septic shock
  • society
  • spinal cord injury
  • systematic review

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Authors

  • Lalu M.M.

  • McIntyre L.

  • Pugliese C.

  • Stewart D.J.

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