Advanced cell therapy with low tissue factor loaded product NestaCell® does not confer thrombogenic risk for critically ill COVID-19 heparin-treated patients

Araldi, Rodrigo Pinheiro; Prezoto, B.C.; Gonzaga, Vivian Fonseca; Policiquio, Bruna de Oliveira; Mendes, Thais Biude; D’Amélio, Fernanda; Vigerelli, Hugo; Viana, Mariana; Valverde, Cristiane Wenceslau; Pagani, Eduardo; Kerkis, Irina

doi:10.1016/j.biopha.2022.112920

Cited by 13 publications

(18 citation statements)

References 49 publications

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“…The reported highest age of the patient category was 69 years, 108 and the lowest age category was 18 years, 106 and the identified age (mean ± SD) is intubated/no comorbidity (48 ± 10.8781), intubated/with comorbidity (62.2857 ± 8.2606), no intubated (56.8571 ± 13.2718); UC-MSC group (n = 65) 60.72 (9.14), placebo group (n = 35) 59.94 (7.79). 111 , 113 The recorded BMI (body mass index), Kg/m2, of the patient is UC-MSC group (n = 65) 24.71 (3.19), placebo group (n = 35) 25.01 (3.12); UC-MSC (n = 12) 34.5 ± 4.5, control (n = 12) 29.6 ± 3.5; UC-MSC (n = 21) 28.6 (3.5), placebo (n = 24) 28 (5.5).…”

Section: Resultsmentioning

confidence: 98%

“…RCT published studies included in the year 2022 were 8; 58 , 86 , 106–111 in 2021 were 5; 1 , 83 , 93 , 112 , 113 in 2020 one study. 88 The RCTs published from different countries were Indonesia-3; 106 , 109 , 112 Iran-2; 58 , 107 Brazil −2; 108 , 110 Turkey-2; 83 , 111 China-2; 1 , 113 Florida-1; 93 UK-1. 88 …”

Section: Resultsmentioning

confidence: 99%

“…The type of MSCs applied in the studies was MSCs-secretome (1); 106 MSCs (1); 111 PL-MSCs; 107 human immature dental pulp stromal cells (hIDP-SCs) (1); 108 DW-MSC infusion (1); 109 WJ-MSCs (1); 83 majority of the studied transfused UC-MSCs (8). 1 , 58 , 86 , 88 , 93 , 110 , 112 , 113 The transfused interventional dosage was 1 × 10 6 cells/kg (6); 58 , 83 , 86 , 93 , 107 , 112 1 × 10 7 cells/kg (4); 1 , 88 , 108 , 109 1 × 10 5 cells/kg (1); 110 1 million cells/kg (1). 111 …”

Section: Resultsmentioning

confidence: 99%

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Effectiveness of RCTs Pooling Evidence on Mesenchymal Stem Cell (MSC) Therapeutic Applications During COVID-19 Epidemic: A Systematic Review

Kandula¹,

Wake²

2023

BTT

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Background Global pandemic identified as coronavirus disease 2019 (COVID-19) has resulted in a variety of clinical symptoms, from asymptomatic carriers to those with severe acute respiratory distress syndrome (SARS) and moderate upper respiratory tract symptoms (URTS). This systematic review aimed to determine effectiveness of stem cell (SC) applications among COVID-19 patients. Methods Multiple databases of PubMed, EMBASE, Science Direct, Google Scholar, Scopus, Web of Science, and Cochrane Library were used. Studies were screened, chosen, and included in this systematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 flowchart diagram and PRISMA checklist. Included studies’ quality was assessed employing Critical Appraisal Skills Programme (CASP) quality evaluation criteria for 14 randomized controlled trials (RCTs). Results Fourteen RCTs were performed between the years of 2020 to 2022, respectively, with a sample size n = 574 (treatment group (n = 318); control group (n = 256)) in multiple countries of Indonesia, Iran, Brazil, Turkey, China, Florida, UK, and France. The greatest sample size reported from China among 100 COVID-19 patients, while the lowest sample of 9 COVID-19 patients from Jakarta, Indonesia, and the patient’s age ranges from 18 to 69 years. Studies applied to the type of SC were “Umbilical cord MSCs, MSCs secretome, MSCs, Placenta-derived MSCs, Human immature dental pulp SC, DW-MSC infusion, Wharton Jelly-derived MSCs”. The injected therapeutic dose was 1 × 10 6 cells/kg, 1 × 10 7 cells/kg, 1 × 10 5 cells/kg, and 1 million cells/kg as per the evidence from the different studies. Studies focused on demographic variables, clinical symptoms, laboratory tests, Comorbidities, respiratory measures, concomitant therapies, Sequential Organ Failure Assessment score, mechanical ventilation, body mass index, adverse events, inflammatory markers, and PaO 2 /FiO 2 ratio were all recorded as study characteristics. Conclusion Clinical evidence on MSC’s therapeutic applications during COVID-19 pandemic has proven to be a promising therapy for COVID-19 patient recovery with no consequences and applied as a routine treatment for challenging ailments.

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Section: Resultsmentioning

confidence: 98%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Effectiveness of RCTs Pooling Evidence on Mesenchymal Stem Cell (MSC) Therapeutic Applications During COVID-19 Epidemic: A Systematic Review

Kandula¹,

Wake²

2023

BTT

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“…However, for share a transcriptomic signature with their origins, it is not surprising that each type of MSC exhibits different therapeutic properties (Da Costa et al, 2021; Kerkis et al, 2022a). In this sense, cumulative evidence have showed that human immature dental pulp stromal/stem cell (hIDPSCs), a special type of adult MSC, isolated from the deciduous teeth of children aged between six to 12 years, is a potential candidate for the treatment of neurodegenerative disorders (Araldi et al, 2022a;Kerkis et al, 2006). This is because, due to their ectomesenchymal origin (neural crest), the hIDPSCs naturally produce and secretes a plethora of neural factors, including nesting (a neural stem/progenitor cell marker) (Kerkis and Caplan, 2012;Suzuki et al, 2010) and brain-derived neurotrophic factor (BDNF, which is found downregulated in patients with Huntington's disease -HD) (Gonzaga et al, 2022;Wenceslau et al, 2022), but showing all the criteria for de ning multipotent MSC proposed by the International Society for Cellular Therapy (Choudhery et al, 2022;Dominici et al, 2006).…”

Section: Introductionmentioning

confidence: 99%

Non-clinical Study of Biodistribution of Human Immature Dental Pulp Stem Cells (Nestacell® Product) Following Intravenous Administration in Mice

Valverde

Gamarra

Gonzaga

et al. 2023

Preprint

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Background: Although the safety of mesenchymal stroma/stem cells (MSCs)-based therapies had already extensively demonstrated, non-clinical biodistribution studies are essential for predicting the safety and efficacy of these cells. Herein we assessed the biodistribution of human immature dental pulp stem cells (hIDPSCs), which has investigated as a candidate for the treatment of Huntington’s disease (HD). Method: For this, we intravenously transplanted hIDPSCs transfected with luciferase or labeled with magnetic nanoparticle in C57BL/6 mice and performed the bioluminescence image (BLI) or inductively coupled plasma mass spectrometer (ICP-MS) to quantity in vivo and ex vivo biodistribution after 4h, 24h, 3, 7, and 30 days of the hIDPSCs administration. Results: BLI’s results showed the presence of hIDPSCs in the chest, lungs, and head after 4h, 24 h, and 3 days of the cell transplantation. No bioluminescent signal was observed in the chest or head on days 7 and 30 days. The ICP-MS’s results showed that the hIDPSCs engraft into the liver, kidney, heart, and lungs. However, the number of hIDPSCs in these sites significantly reduced from the seventh day, being undetectable on the 30th day. By contrast, we observed that the hIDPSCs not only engrafted into the brain, but also remain in this organ for 30 days. Conclusion: These data provide evidence that the hIDPSCs successfully engraft and remain in the brain for until 30 days after the cell transplantation, demonstrating that these cells can migrate and homing to the brain, being a useful candidate for the treatment of neurodegenerative disorders, such as HD.

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“…These characteristics can be related to the biological function of these cells, which are responsible for the maintenance and repair of the periodontal tissue [ 23 ], supporting the DPSC application in dentistry for the regeneration of tooth structures [ 24 , 25 , 26 ] and neurogenesis [ 27 , 28 ]. Based on this, we investigated here, for the first time, the therapeutic potential of human immature dental pulp stem cells (hIDPSCs) for the treatment of AA in a mouse model for AA because the safety and therapeutic potential and multifunctionality of these cells have previously been demonstrated [ 20 , 21 , 29 , 30 , 31 , 32 , 33 ]. Although different mouse models of acquired BM failure have been used to understand the physiopathology of AA or have been employed in preclinical studies, the BM failure induced by radiation is the most commonly used [ 11 , 32 , 34 , 35 , 36 , 37 ].…”

Section: Introductionmentioning

confidence: 99%

Therapeutic Potential of Human Immature Dental Pulp Stem Cells Observed in Mouse Model for Acquired Aplastic Anemia

Gonzaga

Wenceslau²,

Vieira

et al. 2022

Cells

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Aplastic anemia (AA) is a rare and serious disorder of hematopoietic stem cells (HSCs) that results in the loss of blood cells due to the failure of the bone marrow (BM). Although BM transplantation is used to treat AA, its use is limited by donor availability. In this sense, mesenchymal stem cells (MSCs) can offer a novel therapeutic approach for AA. This is because the MSCs contribute to the hematopoietic niche organization through their repopulating. In our study, we used the human immature dental pulp stem cell (hIDPSC), an MSC-like cell, to explore an alternative therapeutic approach for AA. For this, isogenic C57BL/6 mice were exposed to total body irradiation (TBI) to induce the AA. After 48 h of TBI, the mice were intraperitoneally treated with hIDPSC. The immunohistochemistry analyses confirmed that the hIDPSCs migrated and grafted in the mouse bone marrow (BM) and spleen, providing rapid support to hematopoiesis recovery compared to the group exposed to radiation, but not to those treated with the cells as well as the hematological parameters. Six months after the last hIDPSC transplantation, the BM showed long-term stable hematopoiesis. Our data highlight the therapeutic plasticity and hematoprotective role of hIDPSC for AA and potentially for other hematopoietic failures.

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Advanced cell therapy with low tissue factor loaded product NestaCell® does not confer thrombogenic risk for critically ill COVID-19 heparin-treated patients

Cited by 13 publications

References 49 publications

Effectiveness of RCTs Pooling Evidence on Mesenchymal Stem Cell (MSC) Therapeutic Applications During COVID-19 Epidemic: A Systematic Review

Effectiveness of RCTs Pooling Evidence on Mesenchymal Stem Cell (MSC) Therapeutic Applications During COVID-19 Epidemic: A Systematic Review

Non-clinical Study of Biodistribution of Human Immature Dental Pulp Stem Cells (Nestacell® Product) Following Intravenous Administration in Mice

Therapeutic Potential of Human Immature Dental Pulp Stem Cells Observed in Mouse Model for Acquired Aplastic Anemia

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