Exploring the State of the Science in the Field of Regenerative Medicine Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop (2017) / Chapter Skim
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4 Neurological and Ophthalmological Tissues
4 Neurological and Ophthalmological Tissues
Pages 33-42
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From page 33... ...
Potential cells for the thera py include adult retinal pigment epithelial stem cells (RPESCs) , human neural stem cells, and RPE derived from human embryon ic stem cells.
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From page 34... ...
The neurological system is extraordinarily complex, containing multiple cell types and involving complex interactions within and between each neural region; therefore, it is challenging to produce the specific neural cell types that are authentic and appropriate for each specific region. Despite the complexity, there has been progress made in several areas, including retinal pigment epithelium transplantation, oligodendrocyte replacement, and the transplantation of human neural stem cells.
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From page 35... ...
Human Embryonic Stem Cell–Derived RPE An alternative stem cell–based approach to treat AMD was described by Peter Coffey, a professor at the Neuroscience Research Institute of the University of California, Santa Barbara. He told participants about a United Kingdom–based partnership between the University College London Institute of Ophthalmology, the Moorfields Eye Hospital, and Pfizer Neusentis which investigated the possibility of using human embryonic stem cells (hESCs)
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From page 36... ...
After a lengthy and complex regulatory process that involved seven different regulatory bodies and cost approximately £10 million, the group received regulatory approval to conduct the first round of clinical trials. In August 2015 the first human patient received the small patch of hESCderived RPE, which was placed behind the retina, and Coffey's team expects the 12-month clinical outcomes data in late 2016.
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From page 37... ...
Rather than approaching the process serially, beginning with laboratory development and moving onto the other steps as appropriate, the team tried to tackle the project in a more holistic manner. HUMAN NEURAL STEM CELLS Ann Tsukamoto, the former executive vice president of Scientific and Strategic Alliances at StemCells, Inc., shared her company's experience with developing human neural stem cells (HuCNS-SCs®)
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From page 38... ...
Researchers went on to test HuCNS-SCs as a possible treatment for thoracic and cervical spinal cord injuries. In animal models of thoracic spinal cord injury, injected cells migrated, engrafted, and resulted in restored motor function (Cummings et al., 2005)
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From page 39... ...
The mixed results of these studies unfortunately resulted in the company closing its doors, Tsukamoto said. Looking Ahead and Learning from Past Challenges One major hurdle for researchers in the AMD field, Temple said, is to determine how to replace other damaged cell types such as photoreceptors, the cells that lie adjacent to the RPE and rely on it for normal function and survival.
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(Coffey) PANEL DISCUSSION Cell Dosing and Source In the discussion following the presentations, a workshop participant inquired about the rationale underlying the selection of the cell dose for these therapies.
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From page 41... ...
There are currently no good models with which to examine graft-versus-host disease and tolerance induction, Tsukamoto said, and for their experiments they looked to data that had been published on Parkinson's disease patients who received fetal tissue grafts. Although they cannot rule out differences in the patient population (thoracic versus cervical spinal cord injury)
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From page 42... ...
Regulatory Oversight Panelists were asked if they believed that the regulatory burden imposed on the therapies is appropriate for the seriousness of the disease, particularly from a patient perspective. The impact of disease on patients' lives may be something that regulatory agencies do not fully understand, the workshop participant noted, and perhaps risk–benefit analysis may be disease specific.
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