Autologous olfactory ensheathing cell transplantation in human paraplegia: a 3-year clinical trial

Brain, 2008 · DOI: 10.1093/brain/awn173 · Published: August 8, 2008

Spinal Cord Injury Regenerative Medicine Neurorehabilitation

Simple Explanation

This study investigates the safety and feasibility of transplanting a patient's own olfactory ensheathing cells (OECs) into their injured spinal cord. OECs are specialized cells that surround nerve fibers in the olfactory system and have shown promise in animal models for spinal cord repair. The trial involved transplanting OECs into six patients with complete paraplegia and monitoring them for three years to assess safety and any potential benefits.

Study Duration

3 years

Participants

6 patients with complete, thoracic paraplegia and a control group

Evidence Level

Level I/IIa clinical trial

Key Findings

1
The transplantation of autologous olfactory ensheathing cells into the injured spinal cord was found to be feasible and safe for up to 3 years post-implantation.
2
MRI scans showed no adverse effects of the transplantation, such as tumor formation or cyst development.
3
One transplant recipient experienced an improvement in light touch and pin prick sensitivity below the level of injury.

Research Summary

This clinical trial evaluated the safety and feasibility of autologous olfactory ensheathing cell (OEC) transplantation in patients with complete thoracic paraplegia. The study followed six transplant recipients and a control group for 3 years, assessing neurological function, psychosocial status, and radiological outcomes. The results indicated that OEC transplantation is feasible and safe, with one patient showing minor sensory improvements, though the small sample size necessitates further research.

Practical Implications

Safety Confirmation

The study provides preliminary evidence that autologous OEC transplantation is a safe procedure for spinal cord injury, paving the way for further research.

Potential for Sensory Improvement

The observed sensory improvement in one patient suggests a possible therapeutic benefit, warranting further investigation in larger trials.

Refinement of Trial Design

The study highlights the importance of controlled trial designs, blinded assessments, and long-term follow-up in evaluating cell transplantation therapies for spinal cord injury.

Study Limitations

1
Small number of patients in the trial
2
Lack of a sham-surgical control group due to ethical concerns
3
Potential for selection bias due to the requirement for highly motivated patients

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