Phase I/II randomized controlled trial of autologous bone marrow-derived mesenchymal stem cell therapy for chronic stroke

Tsang, Kam Sze; Ng, Chi Ping; Zhu, Xian Lun; Wong, George Kwok Chu; Lü, Gang; Ahuja, Anil T.; Wong, Ka Sing; Ng, Ho Keung; Poon, Wai Sang

doi:10.4252/wjsc.v9.i8.133

Cited by 29 publications

(34 citation statements)

References 37 publications

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“…Patient populations were diverse and included cardiovascular (12 trials, n = 612 patients) [21,24À27,29,37,40,42,44,49,58], neurological (10 trials, n = 242 patients) [30À32, 36,45,48,57,62,65,69], renal (three trials, n = 177 patients) [55,63,67], liver (seven trials, n = 404 patients) [35,43,47,53,54,59,66], respiratory (three trials, n = 134 patients) [18,23,68] and endocrine diseases (four trials, n = 169 patients) [22,28,39,50], hematological/oncological malignancies (five trials, n = 318 patients) [33,34,41,46,71], immune deficient or inflammatory conditions (nine trials, n = 544 patients) [20,38,51,52,60,61,64,70,72], general frailty (one trial, n = 30 patients) [56], and severe sepsis in severely neutropenic patients with hematologic malignancies (one trial, n = 30 patients) [19].…”

Section: Resultsmentioning

confidence: 99%

Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis

et al. 2020

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Background: Characterization of the mesenchymal stromal cell (MSC) safety profile is important as this novel therapy continues to be evaluated in clinical trials for various inflammatory conditions. Due to an increase in published randomized controlled trials (RCTs) from 2012À2019, we performed an updated systematic review to further characterize the MSC safety profile. Methods: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Web of Science (to May 2018) were searched. RCTs that compared intravascular delivery of MSCs to controls in adult populations were included. Pre-specified adverse events were grouped according to: (1) immediate, (2) infection, (3) thrombotic/embolic, and (4) longer-term events (mortality, malignancy). Adverse events were pooled and meta-analyzed by fitting inverse-variance binary random effects models. Primary and secondary clinical efficacy endpoints were summarized descriptively. Findings: 7473 citations were reviewed and 55 studies met inclusion criteria (n = 2696 patients). MSCs as compared to controls were associated with an increased risk of fever (Relative Risk (RR) = 2¢48, 95% Confidence Interval (CI) = 1¢27À4¢86; I 2 = 0%), but not non-fever acute infusional toxicity, infection, thrombotic/ embolic events, death, or malignancy (RR = 1¢16,

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Section: Resultsmentioning

confidence: 99%

Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis

et al. 2020

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“…However, the incidence of side effects in experimental and control groups was not compared in most included trials. Three studies 25 , 35 , 42 conducted the comparison of adverse events including infection, tumor formation, seizures, psychological illness, death and fever. Except death, no significant difference was found for other indicators between the two groups (infection: OR=0.69, CI=0.16–2.99, P =0.62; tumor formation: OR=0.72, CI=0.03–18.56, P =0.84; seizures: OR=1.02, CI=0.26–3.93, P =0.98; psychological illness: OR=1.69, CI=0.53–5.33, P =0.37; death: OR=0.24, CI=0.06–0.88, P =0.03; fever: OR=5.03, CI=0.48–52.71, P =0.18; Figure 7 ).…”

Section: Resultsmentioning

confidence: 99%

“…Based on the NIHSS, 31 , 32 , 36 , 40 , 44 , 45 BI, 23 , 24 , 26 , 27 , 32 , 34 , 36 , 40 , 42 , 44 FMA 28 , 31 , 33 , 36 , 37 , 41 and FIM 27 , 28 , 33 , 37 , 38 , 42 data, funnel plots were drawn for the studies. The funnel plots were symmetrical, indicating no existence of publication bias ( Figures 8 and S5 ).…”

Section: Resultsmentioning

confidence: 99%

Mesenchymal stem cell transplantation as an effective treatment strategy for ischemic stroke in Asia: a meta-analysis of controlled trials

Xue

Wang

Yan

2018

TCRM

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ObjectiveThe aim of this study was to evaluate the efficacy and safety of the mesenchymal stem cell (MSC) therapy in patients with ischemic stroke (IS).Materials and methodsClinical trials involved in this research were searched from PubMed, Web of Science, Cochrane Library, Embase, Wanfang and CNKI database. Therapeutic effects of MSC therapy were assessed according to National Institutes of Health Stroke Scale (NIHSS), Barthel index (BI), Fugl-Meyer Assessment (FMA) and Functional Independence Measure (FIM), and its safety was evaluated based on adverse events.ResultsThis research covered 23 trials including 1,279 IS patients. Based on our analysis, the overall condition of IS patients significantly improved after MSC therapy, indicated by decreased NIHSS and increased BI, FMA and FIM scores. Our analysis also showed that the treatment effects in the MSC transplantation group were superior to those in the control group (routine medication therapy) with statistical significance for NIHSS (1 month after therapy: odds ratio [OR]=−1.92, CI=−3.49 to −0.34, P=0.02; 3 months after therapy: OR=−2.65, CI=−3.40 to −1.90, P<0.00001), BI (1 month after therapy: OR=0.99, CI=0.19–1.79, P=0.02; 6 months after therapy: OR=10.10, CI=3.07–17.14, P=0.005), FMA (3 months after therapy: OR=10.20, CI=3.70–16.70, P=0.002; 6 months after therapy: OR=10.82, CI=6.45–15.18, P<0.00001) and FIM (1 month after therapy: OR=15.61, CI=−0.02 to 31.24, P=0.05; 6 months after therapy: OR=16.56, CI=9.06–24.06, P<0.0001). No serious adverse events were reported during MSC therapy.ConclusionMSC therapy is safe and effective in treating IS by improving the neurological deficits, motor function and daily life quality of patients.

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“…Mesenchymal stem cells (MSCs) are multipotent progenitor cells that have potential for stem cell based restorative therapy (Bianco, 2014;Caplan, 2016). Most recently, numerous pre-clinical and clinical studies have used MSCs based on their immunomodulatory properties that also lead to regeneration of diseased tissue (Hedayatpour et al, 2013;Liang et al, 2013;Liu et al, 2017;Rafei et al, 2009;Tsang et al, 2017;Song et al, 2014;Zhang et al, 2016;Scolding et al, 2017;de Windt et al, 2017ade Windt et al, , 2017b. The immunoregulatory properties of MSCs have been shown in vitro to modulate the action of neutrophils, NK cells as well as B and T lymphocytes (Demircan et al, 2013;Spees et al, 2016).…”

Section: Discussionmentioning

confidence: 99%

Effect of Bone Marrow‐Derived Mesenchymal Stem Cells on Cochlear Function in an Experimental Rat Model

Mittal

Ocak

Zhu

et al. 2019

The Anatomical Record

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Mesenchymal stem cell (MSC) therapy is an emerging treatment modality for various human diseases. Although induced pluripotent stem cells have been explored for the restoration of hearing, the potential of MSCs as a therapeutic strategy for various cochlear insults is not precisely known. MSCs possess anti‐inflammatory, anti‐apoptotic and neuroprotective properties, making them an attractive target for the treatment of inner ear disorders such as hair cell damage in response to inflammation. Most of the previous studies have used immunosuppression or the complex surgical techniques to deliver stem cells into the cochlea. However, no information is available regarding the biocompatibility and safety of MSCs in the inner ear in immunocompetent cochlea. The aim of the present study was to determine the effect of non‐surgical administration of rodent bone marrow derived MSCs (BM‐MSCs) through transtympanic delivery on the cochlear function and to assess any adverse effects on the auditory system employing a rat model without immunosuppression. We observed that the transtympanic administration of BM‐MSCs has no significant effect on the hearing thresholds as determined by auditory brainstem response and distortion product otoacoustic emissions. Histopathological examination revealed no recruitment of inflammatory leukocytes and edema in the cochlea of BM‐MSCs administrated rats. The results of this study suggest that transtympanic administration of BM‐MSCs is safe and can be explored in providing otoprotection against cochlear insults. Anat Rec, 303:487–493, 2020. © 2019 American Association for Anatomy

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Phase I/II randomized controlled trial of autologous bone marrow-derived mesenchymal stem cell therapy for chronic stroke

Cited by 29 publications

References 37 publications

Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis

Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis

Mesenchymal stem cell transplantation as an effective treatment strategy for ischemic stroke in Asia: a meta-analysis of controlled trials

Effect of Bone Marrow‐Derived Mesenchymal Stem Cells on Cochlear Function in an Experimental Rat Model

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