Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020

Ventura-Carmenate, Yendry; Alkaabi, Fatima; Castillo-Aleman, Yandy Marx; Valverde, Carlos Agustín Villegas; Ahmed, Yasmine; Sanna, Pierdanilo; Almarzooqi, Ayesha Abdulla; Abdelrazik, Abeer; Torres-Zambrano, Gina Marcela; Wade-Mateo, Maura; Quesada-Saliba, David; Hadi, Loubna Abdel; Bencomo-Hernández, Antonio A.; Jiménez, Rivero

doi:10.1186/s41231-021-00101-5

Cited by 10 publications

(52 citation statements)

References 46 publications

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“…All included studies were clinical trials, of which ten [ 15 – 24 ] were RCTs while other seven were NRCTs [ 25 – 31 ]. Four studies [ 16 , 17 , 23 , 24 ] were from the same clinical trial, and in addition to safety and efficacy of stem cell therapy, they also reported other characteristics such as radiological changes. Two studies [ 18 , 19 ] by Shu et al reported on the same trial, the first giving the outcome after 28 days and the second being the follow-up report after one year.…”

Section: Resultsmentioning

confidence: 99%

“…For RCT studies, two of them [ 20 , 21 ] lacked comprehensive information on random sequences in the original text, and one study [ 16 ] had obvious missing data. The study by Zhu, R et al [ 20 ] adopted a single-blind method, and the study by Yendry Ventura‑Carmenate et al [ 16 ] is an open-label trial, therefore, the item of blinding of participants and personnel were rated as high risk for these studies. For NRCT studies, all seven of them had control groups.…”

Section: Resultsmentioning

confidence: 99%

“…In the 17 articles included, four types of cell therapies were used: (1) umbilical cord mesenchymal stem cells (UC-MSCs) [ 15 , 18 – 22 , 25 , 27 , 31 ]; (2) human bone marrow mesenchymal stem cells (BM-MSCs) [ 28 ]; (3) menstrual blood-derived mesenchymal stem cells (MenSCs) [ 26 ]; (4) peripheral blood non‑hematopoietic enriched stem cell cocktail (PB‑NHESC‑C) [ 16 , 17 , 23 , 24 ]. Two other studies used mesenchymal stem cells but did not mention the source [ 29 , 30 ].…”

Section: Resultsmentioning

confidence: 99%

“…In the 17 studies involved, six studies mentioned AEs in both experimental and control groups [ 15 , 16 , 18 – 20 , 26 ], while five studies mentioned AE in the experimental group only [ 22 , 25 , 27 , 29 , 30 ]. The other six studies did not mention AEs [ 17 , 21 , 23 , 24 , 28 , 31 ].…”

Section: Resultsmentioning

confidence: 99%

“…Detailed information can be found in Table 2 . It is worth mentioning that two studies reported all AEs from grade 1 to grade 4 according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ 15 , 16 ] while another two studies reported AEs from grade 1 to grade 4 without stating whether CTCAE was referenced [ 18 , 19 , 26 ]. Other studies that mentioned AEs did not describe the specific criteria for AEs or SAEs [ 20 , 22 , 25 , 27 , 29 , 30 ].…”

Section: Resultsmentioning

confidence: 99%

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Safety and efficiency of stem cell therapy for COVID-19: a systematic review and meta-analysis

Zhang

Yan

et al. 2022

glob health res policy

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Background With the COVID-19 pandemic continuing, various treatments have become widely practiced. Stem cells have a wide range of applications in the treatment of lung diseases and have therefore been experimentally used to treat patients with COVID-19, but whether the expanded use of stem cells is safe and reliable still lacks enough evidence. To address this issue, we systematically reviewed the safety and efficiency of stem cell therapy in COVID-19 cases. Methods We searched PubMed, Embase, Web of Science, The Cochrane Library, CNKI, WanFang, VIP and SinoMed up to January 18, 2022. The included studies were assessed using the Risk-of-bias tool 1.0 and MINORS instrument. The adverse events, mortality, length of hospital day and laboratory parameters were analyzed by meta-analysis. We adhered to PRISMA reporting guideline. Results We have included 17 studies meeting the inclusion data. There were no significant differences in AEs (OR = 0·39, 95% CI = 0·12 to 1·33, P = 0·13, I2 = 58%) and SAEs (OR = 0·21, 95% CI = 0·04 to 1·03, P = 0·05, I2 = 0%) between stem cell therapy group and control group. The analysis showed that stem cell treatment could significantly reduce the mortality rate(OR = 0·24, 95% CI = 0·13 to 0·45, P < 0·01, I2 = 0%), but was not able to cause changes in length of hospital stay or most laboratory parameters. Conclusions The present study shows that stem cell therapy for COVID-19 has a remarkable effect on efficiency without increasing risks of adverse events and length of hospital stay. It is potentially necessary to establish the criteria for COVID-19 for stem cell therapy.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Safety and efficiency of stem cell therapy for COVID-19: a systematic review and meta-analysis

Zhang

Yan

et al. 2022

glob health res policy

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Safety and efficacy of mesenchymal stem cells in COVID‐19 patients: A systematic review and meta‐analysis

Yan,

Hu,

Dai

2023

Immunity Inflam & Disease

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BackgroundCoronavirus disease‐19 (COVID‐19) is a zoonotic disease that has become a global pandemic. The fast evolution of the COVID‐19 pandemic and persist problems make COVID‐19 highly infectious; publicly accessible literature and other sources of information continue to expand in volume. The mesenchymal stem cells (MSCs) therapy efficacy for COVID‐19 is debatable.ObjectiveThis systematic review and meta‐analysis (SRMA) aimed to evaluate the usefulness of MSCs in treating COVID‐19.MethodsRelevant publications were retrieved from databases up to April 30, 2022. In the case of dichotomous data, the 95% confidence intervals (CIs) and pooled risk ratio (RR) were estimated with a random effects model (REM) or fixed effects model (FEM). The pooled mean difference (MD) and 95% CIs were calculated with REM or FEM in continuous data. In the outcomes, studies with insufficient or unusable data were reported descriptively.ResultsA total of eight randomized controlled trials (RCTs) with 464 people were chosen for this SRMA. Relative to the control group, mortality was significantly lower in the MSCs group (RR: 0.66, 95% CI: 0.44, 0.99, Z = 2.01, p = .04); other secondary outcomes, such as the clinical symptom improvement rate improved in the MSCs group (RR: 1.44, 95% CI: 1.05, 1.99, Z = 2.24, p = .03), clinical symptom improvement time (MD: −4.01, 95% CI: −6.33, −1.68, Z = 3.38, p = .0007), C‐reactive protein (CRP) (MD: −39.16, 95% CI: −44.39, −33.94, Z = 14.70, p < .00001) and days to hospital discharge (MD: −3.83, 95% CI: −6.19, −1.48, Z = 3.19, p = .001) reduced significantly in MSCs group. However, the adverse reaction incidence did not change significantly.ConclusionsMSCs are a viable therapy option for COVID‐19 because of their safety and potential efficacy. With no significant adverse effects, MSCs can reduce mortality, clinical symptom improvement time, and days to hospital discharge, improve clinical symptoms, and reduce inflammatory cytokines CRP in COVID‐19. However, further high‐quality clinical studies are required to confirm these results.

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Effect and safety of mesenchymal stem cells for patients with COVID‐19: Systematic review and meta‐analysis with trial sequential analysis

Zhang

Shao

Liu

et al. 2023

Journal of Medical Virology

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The objective of this study was to assess whether mesenchymal stem cells (MSCs) therapy could offer survival advantages for patients with novel coronavirus disease 2019 ). An electronic search of PubMed, Embase, Cochrane Library, Web of Science, WanFang, and CNKI was performed from December 1, 2019 to December 25, 2022. The primary outcome was all-cause mortality. Trial sequential analysis (TSA) was conducted in this meta analysis. Besides, subgroup analysis and meta-regression was performed using a random-effects model to find the potential sources of heterogeneity.Seventeen randomized controlled trials (RCTs) involving a total of 1073 patients with COVID-19 were included in this study. Compared with the control group, patients in the MSCs groups were associated with significantly reduced all-cause mortality (MSCs 18.4% vs. control 25.5%; risk ratio [RR] 0.73; 95% confidence interval [CI] 0.59-0.90; p = 0.004; I² = 0%). For all secondary outcomes, there wasn't significant improvement in the experimental group versus the control group regarding symptom remission rate (53.2%, 201/378 vs. 46.5%, 164/353; RR 1.15; 95% CI 1.00-1.32; p = 0.05; I² = 43%), but the pooled analysis revealed significant differences between the groups in length of hospital stay (MD: −3.82, 95% CI: −5.87 to −1.77; p = 0.0003, I2 = 0%), requirement of invasive mechanical ventilation (RR 0.52; 95% CI 0.33-0.82; p = 0.005; I 2 = 0%) and post-CRP level (MD: −31.61; 95% CI −46.74 to −16.49; p < 0.0001). Moreover, regarding the incidence of adverse events (AEs) (RR 0.73; 95% CI 0.35-1.52; p = 0.39; I² = 44%) and serious adverse events (sAEs) (RR 0.87; 95% CI 0.40-1.92; p = 0.73; I² = 39%), no significant differences were observed between MSCs and control groups. The TSA analysis showed that the result of all-cause mortality might be false-positive result. Based on the pooled results in this study, compared with standard treatment, MSCs therapy

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Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020

Cited by 10 publications

References 46 publications

Safety and efficiency of stem cell therapy for COVID-19: a systematic review and meta-analysis

Safety and efficiency of stem cell therapy for COVID-19: a systematic review and meta-analysis

Safety and efficacy of mesenchymal stem cells in COVID‐19 patients: A systematic review and meta‐analysis

Effect and safety of mesenchymal stem cells for patients with COVID‐19: Systematic review and meta‐analysis with trial sequential analysis

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