Introduction The devastating and permanent effects of complete spinal cord injury are well documented. In animal models, olfactory ensheathing cells (OEC) transplanted into areas of complete spinal cord injury have promoted regeneration of the neural elements with reconnection of the descending motor pathways. This reproducible anatomical finding is associated with significant motor functional recovery. Accordingly, cellular transplantation therapies have been advocated for human spinal cord injury.

In a single-blind, Phase I clinical trial, we aimed to test the feasibility and safety of transplantation of autologous olfactory ensheathing cells into the spinal cord of three humans with complete spinal cord injury. This paper describes the trial and the surgical procedures and presents twelve month safety data.

Methods Six patients with paraplegia resulting from chronic (6 – 36 months post-injury) traumatic spinal cord injury (thoracic) were enrolled in the trial. Exclusion criteria included the presence of vertebral column instability, syringomyelia, an implanted spinal device or instrumentation and the presence of psychological instability. The patients were allocated to a treatment group and a control group. No intervention was undertaken to the control group.

Olfactory ensheathing cells were harvested from each subject in the surgery group, grown and purified in vitro. After exposure via laminectomy, durotomy and adhesolysis, the cells were injected into the region of injured spinal cord.

All patients are tested on enrollment and then at regular intervals up to three years by a group of assessors who are blinded to the treatment or control group status. These assessments include physical, radiological, neurophysiological and psychosocial parameters.

Results All surgery patients exhibited continuity of presumed pia through the cystic region at the site of injury. The spinal cord adjacent to the cyst appeared macroscopically normal. There were no complications of surgery evident in the peri-operative period. At twelve months there was no evidence of tumour formation, syrinx development, clinical or psychosocial deterioration.

Discussion The dictum, primum non nocere, is especially relevant to the emerging field of human spinal cord regeneration. Animal models promise such exciting potentials for therapy in this devastating condition, that the possibilities need to be fully explored. Anecdotal, non-trial based reports suggest that equivalent results may be able to be obtained in humans. However, science and care should guide the endeavours in this controversial field.

This is the first reported trial of OEC’s in human spinal cord injury. Twelve-month data in a small cohort shows that there is no evidence of adverse events that would preclude completion of the current trial and the development of efficacy trials.

Study design: Retrospective, descriptive study

Objectives: To describe the characteristics and outcomes of patients with spinal canal stenosis who suffer significant spinal cord injury (SCI) due to hyperextension injury of the cervical spine. To compare their characteristics and outcomes with all patients suffering traumatic cervical SCI and with the total cohort of patients admitted to a Spinal Injuries Unit for rehabilitation.

Setting: Spinal Injuries Unit (SIU), Princess Alexandra Hospital, Brisbane.

Methods: Demographic, injury and outcome data were obtained from an existing database and by review of the medical records of 575 patients admitted to and discharged from the SIU between July 1st, 1995 and July 1st 2002. Main outcome measures were: change in American Spinal Injury Association (ASIA) scale category, change in ASIA motor score, discharge Functional Independence Measure (FIM) score and change in FIM score, length of stay (LOS), primary means of mobility at discharge and discharge destination. Standard statistical methods were used to compare groups.

Results: A total of 18 (3%) of the 575 patients were found to have cervical canal stenosis and hyperextension injury (the CCS/HI group). This represents 8% of the total group suffering traumatic injury to the cervical spinal cord (the total cervical trauma: TCT group, n = 225). This CCS/HI group was found to have a mean age at injury of 55.1 years compared to 37.1 and 37.8 years respectively for the TCT and total groups. Ninety-four percent of patients were found to have a neurological level at admission at C1–3 or C4–5 compared to 75.6% of the TCT group and only 5.6% of patients had an ASIA Impairment Category A lesion at admission compared to 38.7% of the TCT group. Falls (55.6%) was the most common cause of injury in the CCS/HI group with motor vehicle accidents (33.8%) most common in the TCT group.

The mean change in ASIA motor score between admission and discharge was 34.7 compared to 20.4 for the TCT group. Degree of impairment (measured by a change in ASIA Category) improved in 28% of patients and mean change in total FIM score was 41.3. There was no difference seen with the TCT group. LOS was shorter for these patients (111.1 days vs. 161.6 days). The primary means of mobility at discharge was “walking” for 50% of this group (compared to 28.4% for the TCT group) while the next most common means of mobility was “power wheelchair” at 28% (17% of TCT group). Most patients (55.4%) were discharged to their previous home following rehabilitation and 22.3% were discharged to another rehabilitation unit or acute hospital.

Conclusions: Patients with cervical spinal canal stenosis who suffer hyperextension injury constitute a distinct subgroup with the total group of traumatic cervical spinal cord injuries. This study suggests that they are older at the time of injury, have more rostral cervical injuries, are more likely to have incomplete injuries and that falls is the most common cause of injury. They have greater improvement in motor function but this does not appear to result in greater function at discharge as measured by the FIM. There appears to be a dichotomy with results for mobility at discharge with patients either being able to walk or requiring a power wheelchair. LOS in the SIU is shorter but a higher percentage are discharged to another hospital or rehabilitation unit.

STUDY DESIGN: Retrospective, descriptive study.

OBJECTIVES: To describe the characteristics and outcomes of patients with spinal canal stenosis who suffer significant spinal cord injury (SCI) due to hyperextension injury of the cervical spine. To compare their characteristics and outcomes with all patients suffering traumatic cervical SCI and with the total cohort of patients admitted to a Spinal Injuries Unit for rehabilitation.

SETTING: Spinal Injuries Unit (SIU), Princess Alexandra Hospital, Brisbane.

METHODS: Demographic, injury and outcome data were obtained from an existing database and by review of the medical records of 575 patients admitted to and discharged from the SIU between July 1st, 1995 and July 1st 2002. Main outcome measures were: change in American Spinal Injury Association (ASIA) scale category, change in ASIA motor score, discharge Functional Independence Measure (FIM) score and change in FIM score, length of stay (LOS), primary means of mobility at discharge and discharge destination. Standard statistical methods were used to compare groups.

RESULTS: A total of 18 (3%) of the 575 patients were found to have cervical canal stenosis and hyperextension injury (the CCS/HI group). This represents 8% of the total group suffering traumatic injury to the cervical spinal cord (the total cervical trauma: TCT group, n = 225). This CCS/HI group was found to have a mean age at injury of 55.1 years compared to 37.1 and 37.8 years respectively for the TCT and total groups. Ninety-four percent of patients were found to have a neurological level at admission at C1-3 or C4-5 compared to 75.6% of the TCT group and only 5.6% of patients had an ASIA Impairment Category A lesion at admission compared to 38.7% of the TCT group. Falls (55.6%) was the most common cause of injury in the CCS/HI group with motor vehicle accidents (33.8%) most common in the TCT group.

The mean change in ASIA motor score between admission and discharge was 34.7 compared to 20.4 for the TCT group. Degree of impairment (measured by a change in ASIA Category) improved in 28% of patients and mean change in total FIM score was 41.3. There was no difference seen with the TCT group. LOS was shorter for these patients (111.1 days vs. 161.6 days). The primary means of mobility at discharge was “walking” for 50% of this group (compared to 28.4% for the TCT group) while the next most common means of mobility was “power wheelchair” at 28% (17% of TCT group). Most patients (55.4%) were discharged to their previous home following rehabilitation and 22.3% were discharged to another rehabilitation unit or acute hospital.

CONCLUSIONS: Patients with cervical spinal canal stenosis who suffer hyperextension injury constitute a distinct subgroup with the total group of traumatic cervical spinal cord injuries. This study suggests that they are older at the time of injury, have more rostral cervical injuries, are more likely to have incomplete injuries and that falls is the most common cause of injury. They have greater improvement in motor function but this does not appear to result in greater function at discharge as measured by the FIM. There appears to be a dichotomy with results for mobility at discharge with patients either being able to walk or requiring a power wheelchair. LOS in the SIU is shorter but a higher percentage are discharged to another hospital or rehabilitation unit.