Intracranial Delivery of Stem Cells

Muir, Keith W.; Sinden, John D.; Miljan, Erik; Dunn, Lee

doi:10.1007/s12975-011-0095-z

Cited by 19 publications

(12 citation statements)

References 43 publications

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“…The experience in trials of cell implantation for Huntington's or Parkinson's diseases, as well as stroke, includes cell injections targeted to the basal ganglia of 0·5 up to 10 million cells in volumes of 10–200 μl. In a review, 12/238 adverse events related to surgery were reported, consistent in character with a wider literature on stereotaxic surgery that indicates risks of around 1·7% for intracranial bleeding, mostly subdural hemorrhage, and seizures, with an overall mortality of 0·3% and morbidity of 1·4% .…”

Section: Clinical Issuessupporting

confidence: 58%

Stem Cells in Stroke Treatment: The Promise and the Challenges

Sinden

Muir

2012

International Journal of Stroke

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Stroke, for some years now the neglected major indication in the pharmaceutical development cupboard, has recently become one of the hot areas for stem cell therapy development. This is driven by better understanding of potential therapeutic opportunities both in the acute and chronic phases and the launch of a series of new early phase clinical trials in a number of countries, driven by positive data in relevant animal models. In addition, the impetus for stem cell product development is motivated by patient demand, with thousands of victims seeking unproven treatments abroad. This article looks at the many challenges facing the development of a stem cell therapy for stroke. These range from product characterization and banking, through nonclinical safety and efficacy to the regulatory requirements for starting patient trials and beyond to maximizing value from carefully designed efficacy trials.

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Section: Clinical Issuessupporting

confidence: 58%

Stem Cells in Stroke Treatment: The Promise and the Challenges

Sinden

Muir

2012

International Journal of Stroke

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“…There were no cell-related adverse events. Serious adverse events (SAEs) related to the procedure were noted from imaging in 4 out of 11 patients, but none were symptomatic, a finding consistent with general safety data for brain stereotactic procedures [103,104]. No incidence of seizures was recorded, unlike previous trials in which teratocarcinoma-derived neuronal cells [105,106] and fetal porcine cells [107] were implanted to treat stroke.…”

Section: Recent Clinical Experiencesupporting

confidence: 68%

Human Neural Stem Cell Therapy for Chronic Ischemic Stroke: Charting Progress from Laboratory to Patients

SindenJohn

HicksCaroline

StroemerPaul

et al. 2017

Stem Cells and Development

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Chronic disability after stroke represents a major unmet neurologic need. ReNeuron's development of a human neural stem cell (hNSC) therapy for chronic disability after stroke is progressing through early clinical studies. A Phase I trial has recently been published, showing no safety concerns and some promising signs of efficacy. A single-arm Phase II multicenter trial in patients with stable upper-limb paresis has recently completed recruitment. The hNSCs administrated are from a manufactured, conditionally immortalized hNSC line (ReNeuron's CTX0E03 or CTX), generated with c-mycERTAM technology. This technology has enabled CTX to be manufactured at large scale under cGMP conditions, ensuring sufficient supply to meets the demands of research, clinical development, and, eventually, the market. CTX has key pro-angiogenic, pro-neurogenic, and immunomodulatory characteristics that are mechanistically important in functional recovery poststroke. This review covers the progress of CTX cell therapy from its laboratory origins to the clinic, concluding with a look into the late stage clinical future.

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“…While this is certainly an important consideration for any method of opening the BBB, the targeted and transient nature of this FUS-induced BBBO greatly minimizes the risk of adverse exposure, especially compared to more invasive and less targeted approaches (e.g. intracranial injection (Muir et al, 2011) and mannitol-induced BBBO (Nagy et al, 1979)). Additionally, the ability to open the BBB in a targeted manner restricts potentially negative exposures to the affected regions of the brain.…”

Section: Safety Of Focused Ultrasound and Microbubble Mediated Blomentioning

confidence: 99%

Noninvasive and targeted delivery of therapeutics to the brain using focused ultrasound

2017

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The range of therapeutic treatment options for central nervous system (CNS) diseases is greatly limited by the blood-brain barrier (BBB). While a variety of strategies to circumvent the blood-brain barrier for drug delivery have been investigated, little clinical success has been achieved. Focused ultrasound (FUS) is a unique approach whereby the transcranial application of acoustic energy to targeted brain areas causes a noninvasive, safe, transient, and targeted opening of the BBB, providing an avenue for the delivery of therapeutic agents from the systemic circulation into the brain. There is a great need for viable treatment strategies for CNS diseases, and we believe that the preclinical success of this technique should encourage a rapid movement towards clinical testing. In this review, we address the versatile applications of FUS-mediated BBB opening, the safety profile of the technique, and the physical and biological mechanisms that drive this process.

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Intracranial Delivery of Stem Cells

Cited by 19 publications

References 43 publications

Stem Cells in Stroke Treatment: The Promise and the Challenges

Stem Cells in Stroke Treatment: The Promise and the Challenges

Human Neural Stem Cell Therapy for Chronic Ischemic Stroke: Charting Progress from Laboratory to Patients

Noninvasive and targeted delivery of therapeutics to the brain using focused ultrasound

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