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  4. Adverse events of cell therapy clinical trials in human chronic spinal cord injury, a systematic review and meta-analysis

Adverse events of cell therapy clinical trials in human chronic spinal cord injury, a systematic review and meta-analysis

Regenerative Therapy, 2024 · DOI: https://doi.org/10.1016/j.reth.2024.03.012 · Published: March 15, 2024

Spinal Cord InjuryRegenerative MedicineHealthcare

Simple Explanation

This study reviews the safety of cell therapy for chronic spinal cord injury by examining the adverse events reported in clinical trials. The review included 76 studies with over 1600 patients and identified common side effects like backache and urinary issues. No life-threatening events were reported. The researchers concluded that cell therapy appears relatively safe for chronic spinal cord injury, with most side effects being mild to moderate.

Study Duration
Not specified
Participants
1633 cases and 189 controls
Evidence Level
Systematic Review and Meta-Analysis

Key Findings

  • 1
    The most common adverse events were transient backache and meningism (90%) and cord malacia (80%).
  • 2
    The cell therapy method in which the treatment was associated with more adverse events was Olfactory ensheathing cell and bone marrow mesenchymal stem cell combination therapy in 55%, and the adverse events were less with the embryonic stem cell in 2.33% of patients.
  • 3
    The total prevalence of adverse events in cell therapy was 19% and the highest pulled effect size belonged to urinary tract and localized adverse events.

Research Summary

This study analyzed the AE of 14 types of cell therapy clinical trials in human chronic spinal cord injury and showed that in 45 studies of 76 reviewed articles, 64 types of AEs in 12 categories were reported. The most common AEs were transient backache and meningism in 90% of patients and cord malacia in 80% of patients in case groups. The results of our systematic review and meta-analysis emphasized that the safety of various cell therapy methods is remarkable.

Practical Implications

Clinical Practice

Provides clinicians with a comprehensive understanding of potential adverse events associated with different cell therapies for chronic SCI, aiding in patient counseling and management.

Future Research

Highlights the need for standardized AE reporting in clinical trials and longer follow-up periods to assess long-term safety.

Therapeutic Development

Identifies cell therapy methods associated with fewer adverse events (e.g., ESC), suggesting potential avenues for optimizing treatment strategies.

Study Limitations

  • 1
    Non-uniformity of the AEs measurements in different studies
  • 2
    The clinical trials typically assess only a few patients and thus the chances of detecting rare AEs are small.
  • 3
    One of the important limitations of our study was the exclusion of 75 non-English articles in the first stage of screening of the records.

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