Efficacy and safety of stem cell therapy as compared to standard care in patients with spinal cord injury: A meta-analysis
Poorvi Tangri, Manabesh Nath, Bhoomika Arora, Pradeep Kumar, Rajesh Kumar Singh, Deepti Vibha, Kanwaljeet Garg, Awadh Kishor PanditObjectives:
Stem cell intervention shows promise for treating spinal cord injury (SCI) through regenerative mechanisms. This study aimed to thoroughly assess the efficacy and safety of stem cell therapy in SCI patients compared to standard care.
Materials and Methods:
Databases such as Cochrane Central, EMBASE, Web of Science, and PubMed were searched until 30 th April 2025. Randomized controlled trials (RCTs) evaluating clinical outcomes of stem cell interventions versus standard care were included. Data on American Spinal Injury Association (ASIA) scores, ASIA impairment scale grade, spinal cord independence measure (SCIM), and adverse events were extracted. Grading of recommendations, assessment, development, and evaluation (GRADE) methodology and Cochrane’s risk of bias tool were used to assess the risk of bias.
Results:
Twelve RCTs comprising 256 intervention and 203 control subjects were analyzed, among which 11 were considered for meta-analysis. Results indicated a significant improvement in SCIM scores (mean difference [MD] = −9.09; 95% confidence interval [CI]: −12.06–−6.13, I 2 = 0%) and on GRADE assessment showed very-low certainty of evidence of the included studies, ASIA total motor score (MD = −6.58;95% CI: −10.16–−3.00), ASIA sensory score (MD = −10.31;95% CI = −15.79–−4.84), ASIA sensory light touch score (MD = −32.73; 95% CI = −60.80–−4.66), and ASIA sensory pin prick score (MD = −22.32; 95% CI = −32.62–−8.02). Safety outcomes showed no significant increase in total adverse events (relative risk [RR] = 0.60; 95% CI: 0.24–1.48). However, subgroup analysis indicated significantly lower incidence of total adverse events in chronic phase SCI patients undergoing stem cell treatment (RR = 0.33; 95% CI: 0.16–0.69).
Conclusion:
Stem cell therapy may not be recommended as an effective treatment option for SCI patients. Robust and large-scale RCTs are imperative for providing better clinical recommendations involving stem cell therapy.