PMID- 22525310
OWN - NLM
STAT- MEDLINE
DCOM- 20130708
LR  - 20220311
IS  - 1476-5624 (Electronic)
IS  - 1362-4393 (Linking)
VI  - 50
IP  - 9
DP  - 2012 Sep
TI  - Autologous incubated macrophage therapy in acute, complete spinal cord injury: 
      results of the phase 2 randomized controlled multicenter trial.
PG  - 661-71
LID - 10.1038/sc.2012.39 [doi]
AB  - STUDY DESIGN: Randomized controlled trial with single-blinded primary outcome 
      assessment. OBJECTIVES: To determine the efficacy and safety of autologous 
      incubated macrophage treatment for improving neurological outcome in patients 
      with acute, complete spinal cord injury (SCI). SETTING: Six SCI treatment centers 
      in the United States and Israel. METHODS: Participants with traumatic complete 
      SCI between C5 motor and T11 neurological levels who could receive macrophage 
      therapy within 14 days of injury were randomly assigned in a 2:1 ratio to the 
      treatment (autologous incubated macrophages) or control (standard of care) 
      groups. Treatment group participants underwent macrophage injection into the 
      caudal boundary of the SCI. The primary outcome measure was American Spinal 
      Injury Association (ASIA) Impairment Scale (AIS) A-B or better at >/=6 months. 
      Safety was assessed by analysis of adverse events (AEs). RESULTS: Of 43 
      participants (26 treatment, 17 control) having sufficient data for efficacy 
      analysis, AIS A to B or better conversion was experienced by 7 treatment and 10 
      control participants; AIS A to C conversion was experienced by 2 treatment and 2 
      control participants. The primary outcome analysis for subjects with at least 6 
      months follow-up showed a trend favoring the control group that did not achieve 
      statistical significance (P=0.053). The mean number of AEs reported per 
      participant was not significantly different between the groups (P=0.942). 
      CONCLUSION: The analysis failed to show a significant difference in primary 
      outcome between the two groups. The study results do not support treatment of 
      acute complete SCI with autologous incubated macrophage therapy as specified in 
      this protocol.
FAU - Lammertse, D P
AU  - Lammertse DP
AD  - Department of Research, Craig Hospital, Englewood, CO 80113-2811, USA. 
      dlammertse@craighospital.org
FAU - Jones, L A T
AU  - Jones LA
FAU - Charlifue, S B
AU  - Charlifue SB
FAU - Kirshblum, S C
AU  - Kirshblum SC
FAU - Apple, D F
AU  - Apple DF
FAU - Ragnarsson, K T
AU  - Ragnarsson KT
FAU - Falci, S P
AU  - Falci SP
FAU - Heary, R F
AU  - Heary RF
FAU - Choudhri, T F
AU  - Choudhri TF
FAU - Jenkins, A L
AU  - Jenkins AL
FAU - Betz, R R
AU  - Betz RR
FAU - Poonian, D
AU  - Poonian D
FAU - Cuthbert, J P
AU  - Cuthbert JP
FAU - Jha, A
AU  - Jha A
FAU - Snyder, D A
AU  - Snyder DA
FAU - Knoller, N
AU  - Knoller N
LA  - eng
SI  - ClinicalTrials.gov/NCT00073853
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120424
PL  - England
TA  - Spinal Cord
JT  - Spinal cord
JID - 9609749
SB  - IM
MH  - Acute Disease
MH  - Adolescent
MH  - Adult
MH  - Cell- and Tissue-Based Therapy/adverse effects/methods
MH  - Female
MH  - Humans
MH  - Macrophages/*transplantation
MH  - Male
MH  - Middle Aged
MH  - Single-Blind Method
MH  - Spinal Cord Injuries/epidemiology/pathology/*surgery
MH  - Transplantation, Autologous/adverse effects/methods/pathology
MH  - Treatment Failure
MH  - Young Adult
EDAT- 2012/04/25 06:00
MHDA- 2013/07/09 06:00
CRDT- 2012/04/25 06:00
PHST- 2012/04/25 06:00 [entrez]
PHST- 2012/04/25 06:00 [pubmed]
PHST- 2013/07/09 06:00 [medline]
AID - sc201239 [pii]
AID - 10.1038/sc.2012.39 [doi]
PST - ppublish
SO  - Spinal Cord. 2012 Sep;50(9):661-71. doi: 10.1038/sc.2012.39. Epub 2012 Apr 24.