title: Autologous incubated macrophage therapy in acute, complete spinal cord injury: results of the phase 2 randomized controlled multicenter trial.
abstract: METHODS
  Randomized controlled trial with single-blinded primary outcome assessment.
  
  
  OBJECTIVE
  To determine the efficacy and safety of autologous incubated macrophage treatment for improving neurological outcome in patients with acute, complete spinal cord injury (SCI).
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Research, Craig Hospital, Englewood, CO 80113-2811, USA. dlammertse@craighospital.org
authors.forename: D P
authors.initials: DP
authors.lastname: Lammertse
authors.forename: L A T
authors.initials: LA
authors.lastname: Jones
authors.forename: S B
authors.initials: SB
authors.lastname: Charlifue
authors.forename: S C
authors.initials: SC
authors.lastname: Kirshblum
authors.forename: D F
authors.initials: DF
authors.lastname: Apple
authors.forename: K T
authors.initials: KT
authors.lastname: Ragnarsson
authors.forename: S P
authors.initials: SP
authors.lastname: Falci
authors.forename: R F
authors.initials: RF
authors.lastname: Heary
authors.forename: T F
authors.initials: TF
authors.lastname: Choudhri
authors.forename: A L
authors.initials: AL
authors.lastname: Jenkins
authors.forename: R R
authors.initials: RR
authors.lastname: Betz
authors.forename: D
authors.initials: D
authors.lastname: Poonian
authors.forename: J P
authors.initials: JP
authors.lastname: Cuthbert
authors.forename: A
authors.initials: A
authors.lastname: Jha
authors.forename: D A
authors.initials: DA
authors.lastname: Snyder
authors.forename: N
authors.initials: N
authors.lastname: Knoller
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D064987:Cell- and Tissue-Based Therapy / Q000009:adverse effects / Q000379:methods; D005260:Female; D006801:Humans; D008264:Macrophages / Q000637:transplantation*; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D013119:Spinal Cord Injuries / Q000453:epidemiology / Q000473:pathology / Q000601:surgery*; D014182:Transplantation, Autologous / Q000009:adverse effects / Q000379:methods / Q000473:pathology; D017211:Treatment Failure; D055815:Young Adult