Corporate Banner
Satellite Banner
Stem Cells, Cellular Therapy & Biobanking
>
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Encouraging Data from Stem Cell Trial in Stroke Patients as Plans for Phase II Progress

Published: Tuesday, May 28, 2013
Last Updated: Tuesday, May 28, 2013
Bookmark and Share
Encouraging interim data from the world’s first clinical trial examining the safety of neural stem cell treatment in stroke patients has been reported by researchers ahead of an application for Phase II trials.

Updated interim data from the PISCES trial, which has seen the brains of ischaemic stroke patients injected with neural stem cells to test the safety and tolerability of the treatment, was presented to the 22nd European Stroke Conference in London on Tuesday 28 May.

Professor Keith Muir of the University of Glasgow, who is heading the trial of ReNeuron Group plc’s ReN001 stem cell therapy at the Southern General Hospital, Glasgow reported that data from the first nine patients treated has shown no cell-related or immunological adverse affects.

He added that most patients had experienced sustained modest reductions in neurological impairment compared to their pre-treatment baseline performance, accompanied by improvement in abilities to undertake day to day tasks.

              
A further two patients have been treated since the data were collated and the trial is now drawing to a close, with full results due to be published next year.

Meanwhile, plans are proceeding for a Phase II trial which will examine the efficacy of stem cell treatment in stroke patients and an application is expected to be submitted to the UK regulatory authorities in early July. If approved the Phase II trial is scheduled to commence later this year.

The Phase II trial will be a controlled multi-centre trial involving around 20 patients initially, all of whom will have suffered a stroke within a few weeks.

Professor Muir said: “We remain pleased and encouraged by the data emerging from the PISCES study. The data to date identify no safety issues with the ReN001 treatment – which is the primary focus of this Phase I trial.

“The evidence of functional improvement requires further investigation in a suitably designed Phase II efficacy study and we look forward to being a principal clinical site in that study when it commences.”

Michael Hunt, Chief Executive Officer of ReNeuron, said: “The PISCES study continues to yield encouraging results. Assuming the remaining required short-term follow up data confirm the good safety profile of the treatment, we will be able to move the ReN001 therapy confidently into Phase II clinical development, as planned, later this year.”

The Phase II study plan has been adopted by the NHS National Institute for Health Research Stroke Research Network (SRN). This important endorsement will enable ReNeuron to work closely with the SRN to optimise performance against defined targets regarding site set-up, patient recruitment and monitoring activities across the various sites participating in the study.

ReNeuron will seek final regulatory and ethical approvals for the Phase II stroke study by submitting a data package including three month follow-up data on the final dose cohort in the PISCES study to the UK regulatory authorities in early July and, assuming approvals are granted, expects to commence recruitment into the Phase II study shortly thereafter.

The PISCES study is the world’s first fully-regulated clinical trial of a neural stem cell therapy for disabled stroke patients. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world. The trial is being conducted at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,100+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Funding Boost for Precision Medicine Research in Glasgow
The University of Glasgow’s position as a leading centre for the development of precision medicine has been bolstered by the award of £3.4 million from the Medical Research Council and the Engineering and Physical Sciences Research Council (EPSRC) to create the largest MRC Molecular Pathology Node in the UK.
Tuesday, July 28, 2015
Scientific News
A Boost for Regenerative Medicine
Growing tissues and organs in the lab for transplantation into patients could become easier after scientists discovered an effective way to produce three-dimensional networks of blood vessels, vital for tissue survival yet a current stumbling block in regenerative medicine.
Heart Defect Prediction Technology Could Lead to Earlier, More Informed Treatment
Experimental method uses genetics-guided biomechanics, patient-specific stem cells.
Immune Cells Remember Their First Meal
Scientists at the University of Bristol have identified the trigger for immune cells' inflammatory response – a discovery that may pave the way for new treatments for many human diseases.
Cancer Cells Coordinate to Form Roving Clusters
Rice University scientists identify ‘smoking gun’ in metastasis of hybrid cells.
Bio-Mimicry Method For Preparing & Labeling Stem Cells Developed
Method allows researchers to prepare mesenchymal stem cells and monitor them using MRI.
Transcription Factor Isoforms Implicated in Colon Diseases
UC Riverside study explains how distribution of two forms of a transcription factor in the colon influence risk of disease.
New Bio-Glass Could Make it Possible to Re-Grow or Replace Cartilage
Researchers at Imperial College London have developed a material that can mimic cartilage and potentially encourage it to re-grow.
Stem Cell Advance Could Be Key Step Toward Treating Deadly Blood Diseases
UCLA scientists get closer to creating blood stem cells in the lab.
Harnessing Engineered Slippery Surfaces For Tissue Repair
A new method could facilitate the transfer of intact regenerating cell sheets from the culture dish to damaged tissues in patients.
Brazilian Zika Virus Strain Causes Birth Defects in Experimental Models
First direct experimental proof of causal effect, researchers say.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!