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  4. Phase 1 Safety Trial of Autologous Human Schwann Cell Transplantation in Chronic Spinal Cord Injury

Phase 1 Safety Trial of Autologous Human Schwann Cell Transplantation in Chronic Spinal Cord Injury

Journal of Neurotrauma, 2022 · DOI: 10.1089/neu.2020.7590 · Published: February 1, 2022

Spinal Cord InjuryRegenerative MedicineRehabilitation

Simple Explanation

This study explored the safety of transplanting a patient's own Schwann cells into the damaged spinal cord in people with long-term spinal cord injuries. Schwann cells are a type of cell that can help to repair nerve damage. The researchers took a small piece of nerve from the participants, grew Schwann cells in the lab, and then injected them into the injury site in the spinal cord. Participants also underwent a special rehabilitation program before and after the cell transplant. The main goal was to see if this treatment was safe and if it could potentially improve function in people with chronic spinal cord injuries. The study looked at both complete and incomplete spinal cord injuries in the neck and chest areas.

Study Duration
10 Months (on-site study activities) + 5 years post-transplant monitoring
Participants
8 participants with chronic spinal cord injury (4 cervical, 4 thoracic; AIS A, B, C)
Evidence Level
Level 1, Phase 1 open-label, non-randomized clinical trial

Key Findings

  • 1
    The study demonstrated that transplanting autologous human Schwann cells into chronic spinal cord injuries is feasible and appears to be safe.
  • 2
    One participant experienced a notable improvement in motor and sensory function after the cell transplant and rehabilitation.
  • 3
    MRI scans showed a reduction in cyst volume in some participants after transplantation, although this effect decreased over time.

Research Summary

This phase 1 trial assessed the safety and feasibility of autologous human Schwann cell (ahSC) transplantation combined with rehabilitation in chronic SCI patients. The study involved harvesting, culturing, and injecting ahSCs into the spinal cord lesion, followed by a multi-modal rehabilitation protocol. The results indicated that the procedure is feasible and safe, with no serious adverse events reported. Some participants showed improvements in neurological function and a reduction in cyst volume on MRI. The study highlights the potential of ahSC transplantation as a therapeutic approach for chronic SCI, warranting further investigation in larger, controlled trials to assess its efficacy.

Practical Implications

Future Clinical Trials

This study supports further research into cell transplantation therapies for spinal cord injury.

Combination Therapies

Combining cell transplantation with rehabilitation may enhance functional outcomes.

Personalized Dosing

Individualized dosing strategies based on lesion volume can improve treatment outcomes.

Study Limitations

  • 1
    Small sample size
  • 2
    Open-label, non-randomized design
  • 3
    Lack of a control group

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