Meta-analysis of preclinical studies of mesenchymal stromal cells for ischemic stroke
Open accessAbstract
To address patient safety, a drug product is chromatographically screened for organic leachables. Similarly, medical device and packaging system extracts are chromatographically screened for organic extractables as probable leachables. To protect patient health, the screening methods must respond to all potentially unsafe substances. To be efficient, analytes determined to be below the toxicologically relevant threshold are removed from consideration, before the subsequent analytical tasks of identification and quantitation are performed. The analytical evaluation threshold (AET) was established for use as a toxicologically relevant threshold to differentiate between chromatographic peaks that are unlikely to be unsafe (and thus do not need safety assessment) and those that are possibly unsafe (and thus require safety assessment). In practice, the instrumental response associated with the AET is determined using surrogate standards. It is then assumed that the response strength for an unknown extractable is equivalent to that for the surrogate standard at the AET concentration (i.e., relative response factor = 1). It is an unfortunate reality that response factors vary for different compounds on nearly all detector systems. This complicates the application of the AET and can result in a failure to include potentially toxicologically relevant compounds in the identification phase of the analysis. To ensure protection, an uncertainty factor was built into the AET equation which adjusts downward the AET to address response variation. While this mechanism does increase the protectiveness of the AET, it assumes that the available methodology and instrumentation is sufficiently sensitive to reach the new lowered AET value. However, in some cases the response variation is so great and the resulting uncertainty factor so large that the revised AET is below the achievable sensitivity specifications of even state-of-the art, expertly operated instrumental technologies. The only option then remaining is to concentrate the samples which can result in adverse effects on analysis quality − counteracting the perceived benefit of lowering the AET. This manuscript demonstrates how an analytical strategy based on methods with multiple complementary and orthogonal detection techniques (a multidetector approach) mitigates the problem of response factor variation and thus eliminates the need for large uncertainty factors and the resulting lower AET values. The primary concept is that all analytes only need to be effectively detected by at least one of the combination of detectors applied and it is this effective technique (combination of all detectors and chromatographic methods utilized) that is used to perform the AET assessment.
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MSC transplantation for acute stroke improves patient symptoms and promotes neurological recovery in ischemic stroke patients without adverse effects.
“MSC transplantation for acute stroke improves patient symptoms and promotes neurological recovery in ischemic stroke patients without adverse effects.360–362”
From Inflammation and aging: signaling pathways and intervention therapies (2023) · cites this paper as [362]
The Abstract reports improved outcomes in animal models of ischemic stroke, and the Discussion describes favorable behavioral outcomes after MSC treatment. It does not establish symptom improvement or neurological recovery in stroke patients; the Discussion says MSCs have yet to prove effective in humans. The paper mentions an excellent safety record in human trials for other diseases, not an absence of adverse effects in ischemic stroke patients (page numbers unavailable in our copy). (LLM, conf=0.90)
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- Authors
- Vu, Q., Xie, K., Eckert, M., Zhao, W., & Cramer, S. C.
- Affiliations
- University of California, Irvine (US)
- Venue
- Neurology
- Published
- 2014-04-08
- Volume
- 82
- Issue
- 14
- Pages
- 1277-1286
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- PMC
- PMC4001201
- OpenAlex
- W2169093550
- Cited by
- 235
- References
- 58
- Citations by year
- 2026: 8 · 2025: 7 · 2024: 11 · 2023: 22 · 2022: 29 · 2021: 31 · 2020: 20 · 2019: 18 · 2018: 22 · 2017: 22 · 2016: 20 · 2015: 23 · 2014: 2
- FWCI
- 3.41
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Neurology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Institute of Neurological Disorders and Stroke (R01NS059909)
- National Center for Research Resources (5M011 RR-00827-29, M01RR000827)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (K24HD074722)
- Topics
- Health Sciences › Medicine › Genetics › Mesenchymal stem cell research
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
- Keywords
- mesenchymal stem cells, ischemic stroke, preclinical research, patient safety, uncertainty factors
- MeSH terms
- Animals, Brain Ischemia, Disease Models, Animal, Humans, Outcome Assessment, Health Care, Recovery of Function, Stroke, Mice, Rats, Mesenchymal Stem Cells, Cell- and Tissue-Based Therapy
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