Evaluation of the Clinical Efficacy of Stem Cell Transplantation in the Treatment of Spinal Cord Injury: A Systematic Review and Meta-analysis

Tang, Qiaorui; Xue, Hui; Zhang, Qiao; Guo, Ying; Xu, Huiqiong; Liu, Ying; Liu, Jiamei

doi:10.1177/09636897211067804

Cited by 12 publications

(11 citation statements)

References 60 publications

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“…Tang, Q. R. et al. mentioned the pain, fever, and headache as the most common mild and moderate AEs in stem cell transplantation for treatment of spinal cord injury [ 54 ]. The most reported AEs were febrile reaction, headache, and neurologic pain with mild or moderate severity in ten studies in Liu, S. et al.…”

Section: Discussionmentioning

confidence: 99%

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

Davoudi-Monfared,

Abolghasemi,

Allahyari

et al. 2024

Regenerative Therapy

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Section: Discussionmentioning

confidence: 99%

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

Davoudi-Monfared,

Abolghasemi,

Allahyari

et al. 2024

Regenerative Therapy

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“…In order to better highlight the purpose and value of this study, we compared it with previously published studies. A total of 8 systematic reviews/meta-analyses (SR/MA) of stem cells for SCI were searched [ 20 , 21 , 109 – 114 ], as detailed in Table 2 . Although safety is paramount for the clinical application of any therapy, we found that the published SR/MA focused on efficacy indicators while largely ignoring the safety outcomes of stem cell therapy.…”

Section: Similarities and Differences With Similar Studiesmentioning

confidence: 99%

“…2) More adverse effects occurred after stem cell transplantation, mainly including fever (7.59%), headache (5.69%), and neuropathic pain (4.88%). Tang et al [ 20 ] Meta-analysis of head-to-head comparisons 9 328 3 ASIA impairment scale grade; urodynamic indices 1) Compared with conventional treatment, stem cells can significantly improve ASIA and improve bladder function. 2) More AEs occurred after stem cell transplantation, mainly including neuropathic pain (RR = 1.58, 95%CI [0.92, 2.72], p = 0.10), fever (RR = 4.22, 95%CI [1.74, 10.22], p = 0.001), and headache (RR = 2.40, 95%CI [0.57, 10.17], p = 0.23).…”

Section: Similarities and Differences With Similar Studiesmentioning

confidence: 99%

“…However, experts must remain aware that there is still a lot of work to be done. Although systematic reviews of stem cell therapy for SCI have been published previously, they have had certain problems and limitations [ 20 , 21 ]. Most of the current studies are single-arm, early-stage clinical trials with the main purpose of evaluating the safety of stem cells.…”

Section: Introductionmentioning

confidence: 99%

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

Shang

Wang

Zhang

et al. 2022

BMC Med

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Background How much scientific evidence is there to show that stem cell therapy is sufficient in preclinical and clinical studies of spinal cord injury before it is translated into clinical practice? This is a complicated problem. A single, small-sample clinical trial is difficult to answer, and accurate insights into this question can only be given by systematically evaluating all the existing evidence. Methods The PubMed, Ovid-Embase, Web of Science, and Cochrane databases were searched from inception to February 10, 2022. Two independent reviewers performed the literature search, identified and screened the studies, and performed a quality assessment and data extraction. Results In total, 62 studies involving 2439 patients were included in the analysis. Of these, 42 were single-arm studies, and 20 were controlled studies. The meta-analysis showed that stem cells improved the ASIA impairment scale score by at least one grade in 48.9% [40.8%, 56.9%] of patients with spinal cord injury. Moreover, the rate of improvement in urinary and gastrointestinal system function was 42.1% [27.6%, 57.2%] and 52.0% [23.6%, 79.8%], respectively. However, 28 types of adverse effects were observed to occur due to stem cells and transplantation procedures. Of these, neuropathic pain, abnormal feeling, muscle spasms, vomiting, and urinary tract infection were the most common, with an incidence of > 20%. While no serious adverse effects such as tumorigenesis were reported, this could be due to the insufficient follow-up period. Conclusions Overall, the results demonstrated that although the efficacy of stem cell therapy is encouraging, the subsequent adverse effects remain concerning. In addition, the clinical trials had problems such as small sample sizes, poor design, and lack of prospective registration, control, and blinding. Therefore, the current evidence is not sufficiently strong to support the clinical translation of stem cell therapy for spinal cord injury, and several problems remain. Additional well-designed animal experiments and high-quality clinical studies are warranted to address these issues.

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“…Mesenchymal Stem Cells or Mesenchymal Stromal Cells (MSCs) are multipotent progenitor cells, which exhibit the greatest potential for treating spinal cord injury among all stem cell types [7]. Several types of stem cells have been tested or being tested clinically for the treatment of SCI, including MSCs, ESC-derived oligodendrocytes precursor cells, fetal-derived neural stem cells, and central nervous system stem cells [8]. Most of the trials used MSCs isolated from bone marrow (BMSCs), umbilical cord (UC-MSCs) and adipose tissue (ADSCs) to treat SCI [9].…”

Section: Introductionmentioning

confidence: 99%

Role of stem cells transplantation for patients with spinal cord injury: systematic meta-analysis

2023

JPTCP

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Background: Spinal cord injury is a devastating condition that leads to physical, social, and vocational impairment due to the irreversible loss of neural function below the injury site. The objective of this study is to investigate the efficacy and safety of bone marrow mononuclear cells (BM-MNCs) transplant in patients with spinal cord Injury in systematic meta-analysis. Methods: This systematic review and meta-analysis study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The authors searched the PubMed, Web of Science, Cochrane, and Embase databases, OVID, China Biomedical Database (CBM), SinoMed databases and Library databases up to March 15, 2022. Inclusion criteria included for quantitative review, two well-trained author's retrieved independently relevant data from articles included for analysis and cross-checked it. In case of disagreements, a third party was consulted to reach a consensus. The methodological quality of the included studies was assessed independently by two reviewers using the Cochrane Collaboration's ROBINS-I tool for non-randomized studies. Results: Preliminary search database resulted in 549 articles, finally, after excluded all articles did not meet the study criteria 26 studies were included in study and 569 Spinal cord injury patients were included for qualitative analysis in this meta-analysis. Male 77.9% with male/female ration 485/84 variability in the age among included studies. Resulted data showed minor adverse events after bone marrow mononuclear cells (BM-MNCs) transplant; low heterogeneity was observed across each trial (P = 0.11, I2 = 38%). The average risk ratio of these studies was 10.12 (95%CI: 4.24-29.12, p < 0.00003) without heterogeneity (p = 0.81, I2 = 0%) between studies. The methodological quality of the included studies used the standard Cochrane Collaboration tool to analysis is the risk of bias. Conclusions: Bone marrow mononuclear cells (BM-MNCs) significantly improve neurological function in patients with spinal cord injury. Furthermore, this type of procedures has no systemic nor serious complications after autologous transplantation.

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Evaluation of the Clinical Efficacy of Stem Cell Transplantation in the Treatment of Spinal Cord Injury: A Systematic Review and Meta-analysis

Cited by 12 publications

References 60 publications

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

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

Role of stem cells transplantation for patients with spinal cord injury: systematic meta-analysis

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