Safety of autologous bone marrow mononuclear cell transplantation in patients with nonacute ischemic stroke

Battistella, Valeria; Freitas, Gabriel R. de; Fonseca, Léa Mirian Barbosa da; Mercante, Daniel; Gutfilen, Bianca; Goldenberg, Regina Coeli dos Santos; Dias, Juliana; Kasai-Brunswick, Taís Hanae; Wajnberg, Eduardo; Rosado-de-Castro, Paulo Henrique; Alves-Leon, Soniza Vieira; Mendez-Otero, Rosália; André, Charles

doi:10.2217/rme.10.97

Cited by 140 publications

(100 citation statements)

References 52 publications

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“…26 Ten small clinical studies of intravenous or intra-arterial cell delivery, including 136 subjects, have reported findings. [27][28][29][30][31][32][33][34][35][36] The majority of these were small, single-institution safety and tolerability studies. Only three included a control group, and the value of the control groups is questionable, since in many cases they consisted of patients deemed ineligible for the cell therapy intervention, were not randomised, and did not necessarily undergo any study related procedures.…”

Section: The Acute or Early Subacute Paradigmmentioning

confidence: 99%

Clinical trial design for stem cell therapies in stroke: What have we learned?

Muir

2017

Neurochemistry International

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Stem cells of various sources have been investigated in a series of small, safety and feasibility-focused studies over the past 15 years. Understanding of mechanisms of action has evolved and the trial paradigms have become focused on two different approaches -one being an early subacute delivery of cells to reduce acute tissue injury and modify the tissue environment in a direction favourable to reparative processes (for example by being anti-inflammatory, antiapoptotic, and encouraging endogenous stem cell mobilisation); the other exploring later delivery of cells during the recovery phase after stroke to modulate the local environment in favour of angiogenesis and neurogenesis. The former approach has generally investigated intravenous or intra-arterial delivery of cells with an expected paracrine mode of action and no expected engraftment within the brain. The latter has explored direct intracerebral implantation adjacent to the infarct. Several relevant trials have been conducted, including two controlled trials of intravenously delivered bone marrow-derived cells in the early subacute stage, and two small singlearm phase 1 trials of intracerebrally implanted cells. The findings of these studies and their implications for future trial design are considered.Introduction:

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Section: The Acute or Early Subacute Paradigmmentioning

confidence: 99%

Clinical trial design for stem cell therapies in stroke: What have we learned?

Muir

2017

Neurochemistry International

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“…12,13 A large number of preclinical and clinical repair studies have been performed on various systemic diseases, including neurologic disorders and damage. [14][15][16][17][18][19][20][21][22][23][24] But to date, there have been no standardized guidelines for the culture and quality control of MSCs in the neurorestorative clinical application. In order to ensure the safety and effectiveness of clinical application of this type of cells, it is important to standardize the cell culture and quality control processes.…”

Section: Ao Et Almentioning

confidence: 99%

Standards for the culture and quality control of umbilical cord mesenchymal stromal cells for neurorestorative clinical application (2017)

Ao¹,

Yu²,

Mao³

et al. 2017

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“…transplanted autologous bone marrow-derived mononuclear cells (BMNCs) into patients with MCA ischemic stroke within 90 days after symptom onset (non-acute phase) [77] .…”

Section: Ischemic Strokementioning

confidence: 99%

“…Their data indicate that the i.a. transplantation of autologous BMNCs in MCA ischemic stroke is feasible and seems to be safe [77,78] . Recently, Friedrich et al used the same treatment approach at 3-7 days following stroke onset in patients with early or late spontaneous recanalization but with persistent defi cits.…”

Section: Ischemic Strokementioning

confidence: 99%

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Bone marrow stromal cells as a therapeutic treatment for ischemic stroke

Yang

Zhu

et al. 2014

Neurosci. Bull.

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Cerebral ischemia remains the most frequent cause of death and quality-of-life impairments due to neurological deficits, and accounts for the majority of total healthcare costs. However, treatments for cerebral ischemia are limited. Over the last decade, bone marrow stromal cell (BMSC) therapy has emerged as a particularly appealing option, as it is possible to help patients even when initiated days or even weeks after the ischemic insult. BMSCs are a class of multipotent, self-renewing cells that give rise to differentiated progeny when implanted into appropriate tissues. Therapeutic effects of BMSC treatment for ischemic stroke, including sensory and motor recovery, have been reported in pre-clinical studies and clinical trials. In this article, we review the recent progress in BMSC-based therapy for ischemic stroke, focusing on the route of delivery and pre-processing of BMSCs. Selecting an optimal delivery route is of particular importance. The ideal approach, as well as the least risky, for translational applications still requires further identification. Appropriate preprocessing of BMSCs or combination therapy has the benefi t of achieving the maximum possible restoration. Further pre-clinical studies are required to determine the time-window for transplantation and the appropriate dosage of cells.

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Safety of autologous bone marrow mononuclear cell transplantation in patients with nonacute ischemic stroke

Abstract: Intra-arterial bone marrow mononuclear cell transplantation is feasible and safe in patients with nonacute ischemic strokes of the middle cerebral artery. Further studies are required to evaluate the efficacy of this therapy.

Cited by 140 publications

References 52 publications

Clinical trial design for stem cell therapies in stroke: What have we learned?

Clinical trial design for stem cell therapies in stroke: What have we learned?

Standards for the culture and quality control of umbilical cord mesenchymal stromal cells for neurorestorative clinical application (2017)

Bone marrow stromal cells as a therapeutic treatment for ischemic stroke

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