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Article ; Online: How Much Can We Ask of Molecular Biomarkers? An Opinion on Pattinson et al, "Elevated Tau in Military Personnel Relates to Chronic Symptoms Following Traumatic Brain Injury".

Stein, Donald G

The Journal of head trauma rehabilitation

2019 Volume 35, Issue 1, Page(s) 74–75

MeSH term(s)	Biomarkers ; Brain Concussion ; Brain Injuries, Traumatic ; Humans ; Military Personnel
Chemical Substances	Biomarkers
Language	English
Publishing date	2019-05-16
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	639221-0
ISSN	1550-509X ; 0885-9701
ISSN (online)	1550-509X
ISSN	0885-9701
DOI	10.1097/HTR.0000000000000494
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Article ; Online: Response to Korley et al.: Progesterone Treatment Does Not Decrease Serum Levels of Biomarkers of Glial and Neuronal Cell Injury in Moderate and Severe TBI Subjects: A Secondary Analysis of the Progesterone for Traumatic Brain Injury, Experimental Clinical Treatment (ProTECT) III Trial (DOI: 10.1089/neu.2020.7072).

Sayeed, Iqbal / Stein, Donald G

Journal of neurotrauma

2021 Volume 38, Issue 20, Page(s) 2923–2926

MeSH term(s)	Biomarkers/blood ; Brain Injuries, Traumatic/drug therapy ; Humans ; Neuroglia ; Neurons ; Progesterone/therapeutic use
Chemical Substances	Biomarkers ; Progesterone (4G7DS2Q64Y)
Language	English
Publishing date	2021-07-20
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	645092-1
ISSN	1557-9042 ; 0897-7151
ISSN (online)	1557-9042
ISSN	0897-7151
DOI	10.1089/neu.2021.0064
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Article ; Online: Bridging the translational divide: Emerging strategies in pharmacological approaches to traumatic brain injury.

Stein, Donald G / Sayeed, Iqbal

Neuropharmacology

2018 Volume 145, Issue Pt B, Page(s) 131–132

MeSH term(s)	Animals ; Brain Injuries, Traumatic/drug therapy ; Humans ; Neuroprotective Agents/pharmacology ; Neuroprotective Agents/therapeutic use
Chemical Substances	Neuroprotective Agents
Language	English
Publishing date	2018-10-09
Publishing country	England
Document type	Editorial ; Introductory Journal Article
ZDB-ID	218272-5
ISSN	1873-7064 ; 0028-3908
ISSN (online)	1873-7064
ISSN	0028-3908
DOI	10.1016/j.neuropharm.2018.10.007
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Article ; Online: Embracing failure: What the Phase III progesterone studies can teach about TBI clinical trials.

Stein, Donald G

Brain injury

2015 Volume 29, Issue 11, Page(s) 1259–1272

Abstract: Background: Despite positive preclinical studies and two positive Phase II clinical trials, two large Phase III clinical trials of progesterone treatment of acute traumatic brain injury (TBI) recently ended with negative results, so a 100% failure rate ... ...

Abstract	Background: Despite positive preclinical studies and two positive Phase II clinical trials, two large Phase III clinical trials of progesterone treatment of acute traumatic brain injury (TBI) recently ended with negative results, so a 100% failure rate continues to plague the field of TBI trials. Methods: This paper reviews and analyses the trial structures and outcomes and discusses the implications of these failures for future drug and clinical trial development. Persistently negative trial outcomes have led to disinvestment in new drug research by companies and policy-makers and disappointment for patients and their families, failures which represent a major public health concern. The problem is not limited to TBI. Failure rates are high for trials in stroke, sepsis, cardiology, cancer and orthopaedics, among others. Results: This paper discusses some of the reasons why the Phase III trials have failed. These reasons may include faulty extrapolation from pre-clinical data in designing clinical trials and the use of subjective outcome measures that accurately reflect neither the nature of the deficits nor long-term quantitative recovery. Conclusions: Better definitions of injury and healing and better outcome measures are essential to change the embrace of failure that has dominated the field for over 30 years. This review offers suggestions to improve the situation.
MeSH term(s)	Brain Injuries/drug therapy ; Clinical Trials, Phase III as Topic/methods ; Humans ; Outcome Assessment (Health Care) ; Progesterone/therapeutic use ; Progestins/therapeutic use ; Treatment Failure ; Treatment Outcome
Chemical Substances	Progestins ; Progesterone (4G7DS2Q64Y)
Language	English
Publishing date	2015-08-14
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	639115-1
ISSN	1362-301X ; 0269-9052
ISSN (online)	1362-301X
ISSN	0269-9052
DOI	10.3109/02699052.2015.1065344
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Article ; Online: Visual recovery following optic nerve crush in male and female wild-type and TRIF-deficient mice.

Du, Yimeng Lina / Sergeeva, Elena G / Stein, Donald G

Restorative neurology and neuroscience

2020 Volume 38, Issue 5, Page(s) 355–368

Abstract: Background: There is growing evidence that the TIR-domain-containing adapter-inducing interferon-β (TRIF) pathway is implicated in the modulation of neuroinflammation following injuries to the brain and retina. After exposure to injury or to excitotoxic ...

Abstract	Background: There is growing evidence that the TIR-domain-containing adapter-inducing interferon-β (TRIF) pathway is implicated in the modulation of neuroinflammation following injuries to the brain and retina. After exposure to injury or to excitotoxic pathogens, toll-like receptors (TLR) activate the innate immune system signaling cascade and stimulate the release of inflammatory cytokines. Inhibition of the TLR4 receptor has been shown to enhance retinal ganglion cell (RGC) survival in optic nerve crush (ONC) and in ischemic injury to other parts of the brain. Objective: Based on this evidence, we tested the hypothesis that mice with the TRIF gene knocked out (TKO) will demonstrate decreased inflammatory responses and greater functional recovery after ONC. Methods: Four experimental groups -TKO ONC (12 males and 8 females), WT ONC (10 males and 8 females), TKO sham (9 males and 5 females), and WT sham (7 males and 5 females) -were used as subjects. Visual evoked potentials (VEP) were recorded in the left and right primary visual cortices and optomotor response were assessed in all mice at 14, 30, and 80 days after ONC. GFAP and Iba-1 were used as markers for astrocytes and microglial cells respectively at 7 days after ONC, along with NF-kB to measure inflammatory effects downstream of TRIF activation; RMPBS marker was used to visualize RGC survival and GAP-43 was used as a marker of regenerating optic nerve axons at 30 days after ONC. Results: We found reduced inflammatory response in the retina at 7 days post-ONC, less RGC loss and greater axonal regeneration 30 days post-ONC, and better recovery of visual function 80 days post-ONC in TKO mice compared to WT mice. Conclusions: Our study showed that the TRIF pathway is involved in post-ONC inflammatory response and gliosis and that deletion of TRIF induces better RGC survival and regeneration and better functional recovery in mice. Our results suggest the TRIF pathway as a potential therapeutic target for reducing the inflammatory damage caused by nervous system injury.
Language	English
Publishing date	2020-09-18
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1017098-4
ISSN	1878-3627 ; 0922-6028
ISSN (online)	1878-3627
ISSN	0922-6028
DOI	10.3233/RNN-201019
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Zs.A 2792: Show issues

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Book: Brain repair

Stein, Donald G. / Brailowsky, Simón / Will, Bruno E.

das Selbstheilungspotential des Gehirns oder wie das Gehirn sich selbst hilft

2000

Title translation	Les dépannages du cerveau
Title variant	Brain-repair
Author's details	Donald G. Stein, Simón Brailowsky und Bruno Will. Übers. von Jürgen Tesak
Keywords	Hirnschädigung ; Regeneration ; Selbstheilung
Subject	Cerebralschädigung ; Gehirn ; Hirnschaden ; Hirnläsion ; Zerebralschädigung ; Spontanheilung ; Sanatio spontanea ; Spontanremission ; Restitution
Language	German
Size	IX, 130 S.
Publisher	Thieme
Publishing place	Stuttgart u.a.
Publishing country	Germany
Document type	Book
Note	Aus d. Franz. übers.
HBZ-ID	HT011116344
ISBN	3-13-117281-9 ; 978-3-13-117281-5
Database	Catalogue ZB MED Medicine, Health

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1999 A 6730	order for loan	Magazin

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Article ; Online: On improving human clinical trials to the level of animal ischemic stroke studies.

Stein, Donald G

Metabolic brain disease

2014 Volume 30, Issue 2, Page(s) 469–471

Abstract: This is a response to Jickling and Sharp's paper discussing the near-complete failure of clinical trials for stroke interventions. While they propose a paradigm shift in the way preclinical research is conducted, I propose that it is clinical trial ... ...

Abstract	This is a response to Jickling and Sharp's paper discussing the near-complete failure of clinical trials for stroke interventions. While they propose a paradigm shift in the way preclinical research is conducted, I propose that it is clinical trial design that needs an overhaul. Clinical trials could be designed to reduce variance, prevent data entry errors, and encompass less ambitious enrollment criteria limited to fewer centers which have demonstrated expertise in the treatment of stroke (and TBI). Statistical fundamentalism is another soluble problem: clinical trial designs tend to address what is medically significant as opposed to what is primarily statistically significant. Adaptive Design is an alternative to current protocols that needs urgent consideration if we are to get through the Valley of Death between bench and bedside. Maybe it is time to change the clinical trial paradigm to adopt the precise modeling used in good laboratory research rather than asking scientists to give up well-established procedures for producing reliable and reproducible results.
MeSH term(s)	Animals ; Brain Ischemia/drug therapy ; Clinical Trials as Topic/methods ; Data Interpretation, Statistical ; Drug Evaluation, Preclinical/methods ; Humans ; Research Design ; Stroke/drug therapy
Language	English
Publishing date	2014-08-30
Publishing country	United States
Document type	Journal Article
ZDB-ID	632824-6
ISSN	1573-7365 ; 0885-7490
ISSN (online)	1573-7365
ISSN	0885-7490
DOI	10.1007/s11011-014-9613-5
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Zs.A 2155: Show issues

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Article ; Online: Repurposing and repositioning neurosteroids in the treatment of traumatic brain injury: A report from the trenches.

Stein, Donald G / Sayeed, Iqbal

Neuropharmacology

2018 Volume 147, Page(s) 66–73

Abstract: The field of neuroprotection after brain injuries has been littered with failed clinical trials. Finding a safe and effective treatment for acute traumatic brain injury remains a serious unmet medical need. Repurposing drugs that have been in use for ... ...

Abstract	The field of neuroprotection after brain injuries has been littered with failed clinical trials. Finding a safe and effective treatment for acute traumatic brain injury remains a serious unmet medical need. Repurposing drugs that have been in use for other disorders is receiving increasing attention as a strategy to move candidate drugs more quickly to trial while reducing the very high cost of new drug development. This paper describes our own serendipitous discovery of progesterone's neuroprotective potential, and the strategies we are using in repurposing and developing this hormone for use in brain injuries-applications very different from its classical uses in treating disorders of the reproductive system. We have been screening and testing a novel analog that maintains progesterone's therapeutic properties while overcoming its physiochemical challenges, and testing progesterone in combination treatment with another pleiotropic hormone, vitamin D. Finally, our paper, in the context of the problems and pitfalls we have encountered, surveys some of the factors we found to be critical in the clinical translation of repurposed drugs. This article is part of the Special Issue entitled 'Drug Repurposing: old molecules, new ways to fast track drug discovery and development for CNS disorders'.
MeSH term(s)	Animals ; Brain Injuries, Traumatic/drug therapy ; Drug Repositioning ; Humans ; Neuroprotective Agents/pharmacology ; Neuroprotective Agents/therapeutic use ; Neurotransmitter Agents/pharmacology ; Neurotransmitter Agents/therapeutic use ; Progesterone/pharmacology ; Progesterone/therapeutic use
Chemical Substances	Neuroprotective Agents ; Neurotransmitter Agents ; Progesterone (4G7DS2Q64Y)
Language	English
Publishing date	2018-04-06
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	218272-5
ISSN	1873-7064 ; 0028-3908
ISSN (online)	1873-7064
ISSN	0028-3908
DOI	10.1016/j.neuropharm.2018.04.006
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Article ; Online: Progesterone Modulates Mitochondrial Functions in Human Glioblastoma Cells.

Atif, Fahim / Yousuf, Seema / Espinosa-Garcia, Claudia / Stein, Donald G

Molecular neurobiology

2021 Volume 58, Issue 8, Page(s) 3805–3816

Abstract: A substantial literature supports the notion that cancer is a metabolic disease. Mitochondria are sexually dimorphic, and progesterone (P4) plays a key regulatory role in mitochondrial functions. We investigated the effect of P4 on mitochondrial ... ...

Abstract	A substantial literature supports the notion that cancer is a metabolic disease. Mitochondria are sexually dimorphic, and progesterone (P4) plays a key regulatory role in mitochondrial functions. We investigated the effect of P4 on mitochondrial functions in three human glioblastoma multiforme (GBM) cell lines. In dose-response and time-response studies, GBM cells were exposed to different concentrations of P4 followed by mitochondrial stress-testing with a Seahorse analyzer. Data were analyzed for oxygen consumption rate (OCR), extracellular acidification rate (ECAR), and spare respiratory capacity (SRC) to determine the effects of P4 exposure on mitochondrial respiration and rate of glycolysis. We also examined the effect of P4 on mitochondrial superoxide radical generation by confocal microscopy. As early as 1h post-P4 exposure, we found a substantial dose-dependent inhibitory effect of P4 on OCR, ECAR, and SRC in all GBM cell lines. P4 treatment altered the levels of basal respiration, maximum respiration, nonmitochondrial oxygen consumption, ATP production, and proton leak. P4 given at 80-μM concentration showed the maximum inhibitory effect compared to controls. Live imaging data showed an 11-22% increase in superoxide radical generation in all three GBM cell lines following 6h exposure to a high concentration of P4. Our data show that high-dose P4 exerts an inhibitory effect on both mitochondrial respiration and glycolysis in GBM cells. These effects would lead to decreased tumor size and rate of growth, representing a potential treatment to control the spread of GBM.
MeSH term(s)	Animals ; Cell Line, Tumor ; Energy Metabolism/drug effects ; Energy Metabolism/physiology ; Glioblastoma/drug therapy ; Glioblastoma/metabolism ; Humans ; Mitochondria/drug effects ; Mitochondria/metabolism ; Oxygen Consumption/drug effects ; Oxygen Consumption/physiology ; Progesterone/pharmacology ; Progesterone/therapeutic use ; Smegmamorpha
Chemical Substances	Progesterone (4G7DS2Q64Y)
Language	English
Publishing date	2021-04-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	645020-9
ISSN	1559-1182 ; 0893-7648
ISSN (online)	1559-1182
ISSN	0893-7648
DOI	10.1007/s12035-021-02382-1
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Article ; Online: Prophylactic progesterone prevents adverse behavioural and neurocognitive effects of neonatal anaesthesia exposure in rat.

Wali, Bushra / Sayeed, Iqbal / Stein, Donald G / Raper, Jessica

British journal of anaesthesia

2021 Volume 128, Issue 2, Page(s) 301–310

Abstract: Background: Evidence from animal models and human studies suggests an association between early general anaesthesia exposure and development of long-lasting neurocognitive problems including learning and memory impairments and an anxious phenotype. ... ...

Abstract	Background: Evidence from animal models and human studies suggests an association between early general anaesthesia exposure and development of long-lasting neurocognitive problems including learning and memory impairments and an anxious phenotype. Because millions of children each year undergo procedures that require anaesthesia, it is important to investigate ways to protect the vulnerable developing brain. We evaluated whether progesterone treatment administered before general anaesthesia exposure could prevent long-term anaesthesia-induced neurocognitive and behavioural changes. Methods: Female and male Long-Evans rat pups were repeatedly exposed to 2 h of sevoflurane or control procedures at postnatal days 7, 10, and 13. Subcutaneous injections of progesterone or vehicle were administered immediately before general anaesthesia exposure or control procedures. Neurobehavioural and cognitive outcomes were evaluated using elevated plus maze and Morris water maze tests. Results: Prophylactic progesterone treatment attenuated the chemokine (C-X-C motif) ligand 1 (CXCL1) response to sevoflurane exposure. Rats given vehicle treatment with general anaesthesia exposure exhibited increased anxiety on the elevated plus maze and learning and memory impairments on the Morris water maze. However, rats treated with progesterone before general anaesthesia lacked these impairments and performed in a similar manner to controls on both tasks. Conclusions: Progesterone attenuated the anaesthesia-induced, acute peripheral inflammatory response and prevented cognitive and behavioural alterations associated with early repeated general anaesthesia exposure. Importantly, our results suggest that progesterone treatments given before general anaesthesia may help to protect the developing brain.
MeSH term(s)	Anesthetics, Inhalation/administration & dosage ; Anesthetics, Inhalation/toxicity ; Animals ; Animals, Newborn ; Behavior, Animal/drug effects ; Cognitive Dysfunction/chemically induced ; Cognitive Dysfunction/prevention & control ; Female ; Male ; Maze Learning/drug effects ; Memory Disorders/chemically induced ; Memory Disorders/prevention & control ; Progesterone/administration & dosage ; Progesterone/pharmacology ; Rats ; Rats, Long-Evans ; Sevoflurane/administration & dosage ; Sevoflurane/toxicity ; Time Factors
Chemical Substances	Anesthetics, Inhalation ; Sevoflurane (38LVP0K73A) ; Progesterone (4G7DS2Q64Y)
Language	English
Publishing date	2021-12-15
Publishing country	England
Document type	Journal Article
ZDB-ID	80074-0
ISSN	1471-6771 ; 0007-0912
ISSN (online)	1471-6771
ISSN	0007-0912
DOI	10.1016/j.bja.2021.10.030
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