Clinical translation of stem cell therapy for spinal cord injury still premature: results from a single‑arm meta‑analysis based on 62 clinical trials

BMC Medicine, 2022 · DOI: https://doi.org/10.1186/s12916-022-02482-2 · Published: September 1, 2022

Spinal Cord Injury Regenerative Medicine Research Methodology & Design

Simple Explanation

Researchers conducted a meta-analysis of 62 clinical trials to assess the effectiveness and safety of stem cell therapy for spinal cord injury (SCI). They found that stem cell therapy can lead to improvements in some patients, but also carries the risk of adverse effects. The analysis showed that stem cells improved motor function in some SCI patients. Additionally, improvements were noted in urinary and gastrointestinal system functions. However, the extent of these improvements may not fully meet patient expectations. The study highlights that current clinical trials have limitations such as small sample sizes and poor design. These issues make it difficult to confirm the efficacy and safety of stem cell therapy, suggesting that more rigorous research is needed before widespread clinical translation.

Study Duration

Not specified

Participants

2439 patients

Evidence Level

Level III, Meta-analysis of clinical trials

Key Findings

1
Stem cell therapy improved the ASIA impairment scale score by at least one grade in 48.9% of patients with spinal cord injury, indicating a slight improvement in sensory and motor function.
2
Adverse effects were observed, including neuropathic pain, abnormal feeling, muscle spasms, vomiting, and urinary tract infection, with an incidence of over 20% each.
3
The analysis of adverse effects based on the source of stem cells revealed that UCMSCs were associated with the most types of AEs (15 types), followed by BMSCs (12 types), NSCs (10 types), HSCs (9 types), ESCs (5 types), ADM-SCs (4 types), and CBSCs (1 type).

Research Summary

This meta-analysis of 62 clinical trials evaluated the benefits and risks of stem cell therapy for spinal cord injury (SCI), finding that stem cells can lead to improvements in motor function and urinary/gastrointestinal function in some patients. The study identified 28 types of adverse effects associated with stem cell therapy, including neuropathic pain and muscle spasms, indicating that the safety of stem cell therapy remains a concern. The authors concluded that current clinical trial evidence is insufficient to support widespread clinical translation of stem cell therapy for SCI due to limitations in trial design and safety concerns, emphasizing the need for additional high-quality studies.

Practical Implications

Caution in Clinical Translation

The study suggests that widespread clinical use of stem cell therapy for SCI should be approached with caution until further high-quality clinical studies can confirm its safety and efficacy.

Improvement of Clinical Trial Design

There is a need to improve the design and implementation of clinical trials for stem cell therapy, including larger sample sizes, control groups, blinding, and prospective registration.

Focus on Patient Safety

Patient safety should be prioritized, and comprehensive reporting of adverse events is crucial for assessing the true risk-benefit ratio of stem cell therapy.

Standardization of Methods

Standardizing stem cell therapy protocols is needed to decrease the heterogeneity among study designs, and enable comparison of outcomes across different patient groups.

Study Limitations

1
Heterogeneity among studies regarding patient characteristics, stem cell types, and treatment protocols.
2
Inclusion of only studies published in English and exclusion of grey literature and conference abstracts.
3
Lack of prospective registration of the study protocol, which may have led to reporting bias.

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