The Alpha Stem Cell Clinic: A Model for Evaluating and Delivering Stem Cell-Based Therapies
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Summary: Cellular therapies require the careful preparation, expansion, characterization, and delivery of cells in a clinical environment. There are major challenges associated with the delivery of cell therapies and high costs that will limit the companies available to fully evaluate their merit in clinical trials, and will handicap their application at the present financial environment. Cells will be manufactured in good manufacturing practice or near-equivalent facilities with prerequisite safety practices in place, and cell delivery systems will be specialized and require well-trained medical and nursing staff, technicians or nurses trained to handle cells once delivered, patient counselors, as well as statisticians and database managers who will oversee the monitoring of patients in relatively long-term follow-up studies. The model proposed for Alpha Stem Cell Clinics will initially use the capacities and infrastructure that exist in the most advanced tertiary medical clinics for delivery of established bone marrow stem cell therapies. As the research evolves, they will incorporate improved procedures and cell preparations. This model enables commercialization of medical devices, reagents, and other products required for cell therapies. A carefully constructed cell therapy clinical infrastructure with the requisite scientific, technical, and medical expertise and operational efficiencies will have the capabilities to address three fundamental and critical functions: 1) fostering clinical trials; 2) evaluating and establishing safe and effective therapies, and 3) developing and maintaining the delivery of therapies approved by the Food and Drug Administration, or other regulatory agencies.
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Some institutions have merged their common experiences to try to avoid repetition of errors and associated costs.
“To try and avoid the repetition or errors and the associated costs, some institutions have merged their common experiences (notable examples are California’s Alpha Stem Cell Clinics, supported by the California Institute for Regenerative Medicine108,109, the UK Catapult Program in Cell Therapies and the Ontario Institute for Regenerative Medicine).”
From How to design preclinical studies in nanomedicine and cell therapy to maximize the prospects of clinical translation (2018) · cites this paper as [108]
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- Authors
- Trounson, A., DeWitt, N. D., & Feigal, E. G.
- Affiliations
- California Institute for Regenerative Medicine (US)
- Corresponding author
- Trounson, Alan
- Venue
- Stem Cells Translational Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-12-07
- Volume
- 1
- Issue
- 1
- Pages
- 9-14
- ISSN
- 2157-6564 (ISSN-L)
- 2157-6580
- PMC
- PMC3727684
- OpenAlex
- W2138929311
- Cited by
- 33
- References
- 21
- Citations by year
- 2026: 1 · 2025: 2 · 2022: 2 · 2021: 2 · 2020: 1 · 2019: 3 · 2018: 2 · 2017: 1 · 2016: 2 · 2015: 3 · 2014: 7 · 2013: 4 · 2012: 3
- FWCI
- 3.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Stem Cells Translational Medicine (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Pluripotent Stem Cells Research
- Health Sciences › Medicine › Genetics › Mesenchymal stem cell research
- Keywords
- stem cell therapy, cell therapy delivery, clinical infrastructure, cell manufacturing, good manufacturing practices, clinical trials, regulatory approval
- MeSH terms
- Animals, Cooperative Behavior, Health Facilities, Humans, Interinstitutional Relations, Research Support as Topic, United States, Models, Organizational, Health Care Sector, Biomedical Research, Regenerative Medicine, Stem Cell Research, Health Facility Administration
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