Safety and Efficacy of Stem Cell Therapy in Patients With Ischemic Stroke

Abstract

Stem cell therapy is emerging as a promising treatment strategy to treat patients with stroke. While there are established modes of treatment for stroke patients such as thrombolysis and endovascular intervention, most of the stroke patients frequently end up with major residual deficits or even death. The use of stem cells to treat stroke has been found to be beneficial in the animal models but strict evidence for the same in humans is still lacking. We reviewed 13 clinical trials of stem cell therapy in stroke patients conducted between 2014 and 2020 based on the search using the database PubMed, and the clinical trial registry ( www.clinicaltrials.gov ). We aimed to assess the safety and efficacy of stem cell treatment in stroke patients who participated in the trials. Quality assessment of the clinical trials revealed a sub-optimal score. We found mixed results regarding the efficacy of stem cells in the treatment of ischemic stroke although we could not do a quantitative analysis of the effect outcomes. Assessment for safety revealed promising results as there were only minor side effects related to cell therapy. Although stem cell therapy seems to be a promising strategy to treat stroke patients in the future, we concluded that the field needs more evidence regarding the safety and efficacy of the use of stem cells in stroke patients before we use them in the clinic.

Clinical outcome and safety of stem cell therapy for ischemic stroke: A systematic review and meta-analysis

“…This observation is in accordance to the results of the majority of the previous studies, in which most stem cell therapy trials were reported to be safe, aside from their effect on improved functional outcome. [ 12 ] Safety itself is dependent on multiple factors, including the host and the stem cells themselves. Indeed, type, source, dose, route of delivery, and time from onset of stroke to stem cell administration all contribute to the safety and outcome of stem cell therapy in stroke patients.…”

An overview of mesenchymal stem cells and their potential therapeutic benefits in cancer therapy (Review)

“…In neurology, ischaemic stroke patients treated with MSCs yielded positive results, whereby the patients showed significantly improved neurological and motor functions (85)(86)(87)(88). Among all of the studies conducted, serious adverse events that were reported included transient ischaemic attack, seizure, asymptomatic subdural haematoma/hygroma, urinary tract infection, sepsis, pneumonia, hyperglycaemia, neutrophilia, shingles, ischaemic stroke, cellulitis, muscle cramps, fracture neck femur, and peripheral vascular disease (89). However, these side effects were attributed to the procedure rather than cell therapy.…”

Dynamic MRI of the Mesenchymal Stem Cells Distribution during Intravenous Transplantation in a Rat Model of Ischemic Stroke

“…This route of administration has become even more relevant due to the widespread use of endovascular treatment methods in acute stroke patients [ 23 ], despite this procedure requiring technical precision due to the risk of cerebral embolism [ 24 ]. Intravenous administration (IV) has also shown therapeutic efficacy and is the most commonly used, because it is less invasive, has minimal risk of adverse events, can be easily applied multiple times, and is suitable even for patients in critical clinical conditions [ 20 , 25 , 26 , 27 ]. Finding the optimal route of transplantation, as well as timing and the dosage of cells, is a challenging task due to the poor understanding of the exact mechanisms of MSCs’ action.…”