Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Monday, August 22, 2016

TOOTH (The Open study Of dental pulp stem cell Therapy in Humans): Study protocol for evaluating safety and feasibility of autologous human adult dental pulp stem cell therapy in patients with chronic disability after stroke

You will notice that there is no mention of even measuring if the stem cells survived. Totally worthless research, stroke leaders should be reaming out researchers who attempt this crap. Does no one in the stroke world even know how to design research?
http://wso.sagepub.com/content/11/5/575.abstract
  1. Anjali Nagpal1
  2. Karlea L Kremer1
  3. Monica A Hamilton-Bruce2,3
  4. Xenia Kaidonis1
  5. Austin G Milton2
  6. Christopher Levi4
  7. Songtao Shi5
  8. Leeanne Carey6,7
  9. Susan Hillier8
  10. Miranda Rose7
  11. Andrew Zacest9
  12. Parabjit Takhar10
  13. Simon A Koblar3,11⇑
  1. 1School of Medicine, The University of Adelaide, South Australian Health and Medical Research Institute (SAHMRI), Adelaide, South Australia
  2. 2Neurology Department, The Queen Elizabeth Hospital, Woodville, South Australia
  3. 3School of Medicine, University of Adelaide, Adelaide, South Australia
  4. 4Hunter Medical Research Institute, University of Newcastle, New South Wales, Australia
  5. 5School of Dental Medicine, University of Pennsylvania, Philadelphia, USA
  6. 6Neurorehabilitation and Recovery research group, Stroke Division, Florey Institute of Neuroscience and Mental Health La Trobe University, Melbourne, Victoria, Australia
  7. 7School of Allied Health, La Trobe University, Melbourne, Australia
  8. 8Health Sciences Divisional Office School of Health Sciences, University of South Australia, Adelaide, South Australia
  9. 9Department of Neurosurgery, Royal Adelaide Hospital, Adelaide, South Australia
  10. 10Molecular Imaging and Therapy Research Unit, South Australian Health and Medical Research Institute, Adelaide, South Australia
  11. 11SAHMRI & Basil Hetzel Institute, The Queen Elizabeth Hospital, Woodville, South Australia
  1. Simon A Koblar, Stroke Research Programme, SAHMRI & School of Medicine, University of Adelaide, Adelaide South Australia, South Australia. Email: simon.koblar@adelaide.edu.au

Abstract

Rationale Stroke represents a significant global disease burden. As of 2015, there is no chemical or biological therapy proven to actively enhance neurological recovery during the chronic phase post-stroke. Globally, cell-based therapy in stroke is at the stage of clinical translation and may improve neurological function through various mechanisms such as neural replacement, neuroprotection, angiogenesis, immuno-modulation, and neuroplasticity. Preclinical evidence in a rodent model of middle cerebral artery ischemic stroke as reported in four independent studies indicates improvement in neurobehavioral function with adult human dental pulp stem cell therapy. Human adult dental pulp stem cells present an exciting potential therapeutic option for improving post-stroke disability.
Aims TOOTH (The Open study Of dental pulp stem cell Therapy in Humans) will investigate the use of autologous stem cell therapy for stroke survivors with chronic disability, with the following objectives: (a) determine the maximum tolerable dose of autologous dental pulp stem cell therapy; (b) define that dental pulp stem cell therapy at the maximum tolerable dose is safe and feasible in chronic stroke; and (c) estimate the parameters of efficacy required to design a future Phase 2/3 clinical trial.
Methods and design TOOTH is a Phase 1, open-label, single-blinded clinical trial with a pragmatic design that comprises three stages: Stage 1 will involve the selection of 27 participants with middle cerebral artery ischemic stroke and the commencement of autologous dental pulp stem cell isolation, growth, and testing in sequential cohorts (n = 3). Stage 2 will involve the transplantation of dental pulp stem cell in each cohort of participants with an ascending dose and subsequent observation for a 6-month period for any dental pulp stem cell-related adverse events. Stage 3 will investigate the neurosurgical intervention of the maximum tolerable dose of autologous dental pulp stem cell followed by 9 weeks of intensive task-specific rehabilitation. Advanced magnetic resonance and positron emission tomography neuro-imaging, and clinical assessment will be employed to probe any change afforded by stem cell therapy in combination with rehabilitation.
Sample size estimates Nine participants will step-wise progress in Stage 2 to a dose of up to 10 million dental pulp stem cell, employing a cumulative 3 + 3 statistical design with low starting stem cell dose and subsequent dose escalation, assuming that an acceptable probability of dose-limiting complications is between 1 in 6 (17%) and 1 in 3 (33%) of patients. In Stage 3, another 18 participants will receive an intracranial injection with the maximum tolerable dose of dental pulp stem cell.
Outcomes The primary outcomes to be measured are safety and feasibility of intracranial administration of autologous human adult DPSC in patients with chronic stroke and determination of the maximum tolerable dose in human subjects. Secondary outcomes include estimation of the measures of effectiveness required to design a future Phase 2/3 clinical trial.
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