OBJECTIVES: To assess the effects of cell-based therapy for people with ALS/MND, compared with placebo or no treatment.
SEARCH METHODS: On 31 July 2019, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, and Embase. We also searched two clinical trials registries for ongoing or unpublished studies.
SELECTION CRITERIA: We included RCTs that assigned people with ALS/MND to receive cell-based therapy versus a placebo or no additional treatment. Co-interventions were allowed, provided that they were given to each group equally.
DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology.
MAIN RESULTS: Two RCTs involving 112 participants were eligible for inclusion in this review. One study compared autologous bone marrow-mesenchymal stem cells (BM-MSC) plus riluzole versus control (riluzole only), while the other study compared combined intramuscular and intrathecal administration of autologous mesenchymal stem cells secreting neurotrophic factors (MSC-NTF) to placebo. The latter study was reported as an abstract and provided no numerical data. Both studies were funded by biotechnology companies. The only study that contributed to the outcome data in the review involved 64 participants, comparing BM-MSC plus riluzole versus control (riluzole only). It reported outcomes after four to six months. It had a low risk of selection bias, detection bias and reporting bias, but a high risk of performance bias and attrition bias. The certainty of evidence was low for all major efficacy outcomes, with imprecision as the main downgrading factor, because the range of plausible estimates, as shown by the 95% confidence intervals (CIs), encompassed a range that would likely result in different clinical decisions. Functional impairment, expressed as the mean change in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score from baseline to six months after cell injection was slightly reduced (better) in the BM-MSC group compared to the control group (mean difference (MD) 3.38, 95% CI 1.22 to 5.54; 1 RCT, 56 participants; low-certainty evidence). ALSFRS-R has a range from 48 (normal) to 0 (maximally impaired); a change of 4 or more points is considered clinically important. The trial did not report outcomes at 12 months. There was no clear difference between the BM-MSC and the no treatment group in change in respiratory function (per cent predicted forced vital capacity; FVC%; MD -0.53, 95% CI -5.37 to 4.31; 1 RCT, 56 participants; low-certainty evidence); overall survival at six months (risk ratio (RR) 1.07, 95% CI 0.94 to 1.22; 1 RCT, 64 participants; low-certainty evidence); risk of total adverse events (RR 0.86, 95% CI 0.62 to 1.19; 1 RCT, 64 participants; low-certainty evidence) or serious adverse events (RR 0.47, 95% CI 0.13 to 1.72; 1 RCT, 64 participants; low-certainty evidence). The study did not measure muscle strength.
AUTHORS' CONCLUSIONS: Currently, there is a lack of high-certainty evidence to guide practice on the use of cell-based therapy to treat ALS/MND. Uncertainties remain as to whether this mode of therapy is capable of restoring muscle function, slowing disease progression, and improving survival in people with ALS/MND. Although one RCT provided low-certainty evidence that BM-MSC may slightly reduce functional impairment measured on the ALSFRS-R after four to six months, this was a small phase II trial that cannot be used to establish efficacy. We need large, prospective RCTs with long-term follow-up to establish the efficacy and safety of cellular therapy and to determine patient-, disease- and cell treatment-related factors that may influence the outcome of cell-based therapy. The major goals of future research are to determine the appropriate cell source, phenotype, dose and method of delivery, as these will be key elements in designing an optimal cell-based therapy programme for people with ALS/MND. Future research should also explore novel treatment strategies, including combinations of cellular therapy and standard or novel neuroprotective agents, to find the best possible approach to prevent or reverse the neurological deficit in ALS/MND, and to prolong survival in this debilitating and fatal condition.
MATERIALS AND METHODS: This cross-sectional study was conducted from May to July 2022 in urban areas in Selangor among children aged less than two years old from B40 households using purposive sampling through both online surveys and face-to-face interviews. There were 112 children aged < 2 years old from B40 households participating in this study. The data obtained on maternal sociodemographic, Household Food Insecurity Scale (HFIAS), and children's anthropometric measurements were analysed by using the WHO Anthro Survey, descriptive analysis, Person's Chisquare test and Fischer's exact test.
RESULTS: The prevalence of food insecurity was more significant than the prevalence of food secured, at 55.4% and 44.6% respectively. The stunting among the children rated at 34.8%, followed by 7.2% of the sample found underweight, 7.8% (BAZ) and 16.1% (BAZ) of them were wasted, and overweight & obese, proportionately. This study discovered that household size was the sole determinant of household food security status. This finding suggested that size of a household influenced the odds of a household being food insecure.
CONCLUSION: The findings of this study provide insights into how the COVID-19 pandemic have an impact on children's nutritional status especially those from low-income and bigger size households. Therefore, more thorough and effective interventions should be designed particularly targeting this urban poor community to enhance their nutritional status and health.
Methods: Patients diagnosed with BPH with severe LUTS who had undergone PAE were included. Their IPSS score was ≥ 20 despite medical therapy. PAE was performed via the unilateral femoral artery using various types of embolic material. Bilateral or unilateral embolisation of the prostate artery was considered a technical success. The severity of LUTS pre- and post-PAE were assessed using IPSS while prostate volume pre- and post-PAE were assessed by ultrasound and magnetic resonance imaging (MRI).
Results: Ninety percent of patients had technical success and one required transurethral resection of the prostate (TURP). The mean IPSS reduction at the final follow-up was 12.9 (P < 0.028). The mean reduction of prostate volume at the last follow-up by ultrasound was 114.99 mL (P < 0.028) and by MRI was 29.17 mL (P < 0.028).
Conclusion: PAE is safe and effective in reducing severe LUTS and prostate gland volume in BPH patients.