First Stroke Patient Treated With Neural Stem Cell Therapy

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The first patient in the landmark Pilot Investigation of Stem Cells in Stroke (PISCES) trial has been treated with neural stem cells. The study is the first fully regulated clinical trial of neural stem cell therapy for stroke. Investigators will evaluate the safety of ReNeuron cells in disabled ischemic stroke patients.

“This is a first in man safety study,” lead investigator Keith Muir, MD, from the University of Glasgow‘s Institute of Neuroscience and Psychology in Scotland, explained to Medscape Medical News. “We are looking at neurological effects — clinical and imaging — only as secondary goals.”

The stem cells are from a genetically modified immortalized cell line derived from a tissue sample from 12-week fetal cortex.

“Critics of stem cell development generally have various reasons for their ethical objections,” Dr. Muir said. “For most, it relates to embryo use — not relevant in this case,” he argues. “Others might object to termination of pregnancy, but these cells are derived from material donated to a tissue bank from a single legal termination many years ago, which was done for social reasons and was unrelated to the subsequent use.”

This study was approved by the United Kingdom Medicines and Healthcare Products Regulatory Agency. ReNeuron is the first company to receive regulatory approval for any stem cell–based clinical trial in the United Kingdom.

PISCES Trial

The first patient in this pilot investigation was treated in Glasgow. The male patient was injected with cells to the affected region of the brain and has since been discharged from the hospital. He will be monitored closely for 2 years with longer-term follow-up procedures afterward.

Investigators are still recruiting for the trial and plan for 12 patients to take part. They will be given the ReN001 therapy between 6 and 24 months after stroke.

PISCES is an open-label study with no control group. “We feel this is an appropriate design for a first in man study,” Dr. Muir said, “and we are not seeking to draw conclusions about efficacy at this stage.”

Trial investigators suggest that because of the nature of the procedure and the characteristics of the stem cells, immunosuppression will not be necessary for patients taking part in the study. This, they say, will eliminate the safety risks typically associated with immunosuppression regimens.

Michael Hunt, chief executive officer of ReNeuron, said in a news release, “Our thanks and best wishes go to the first patient and his family for their participation in this important and groundbreaking clinical trial.”

from http://www.medscape.com/viewarticle/732879

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7 thoughts on “First Stroke Patient Treated With Neural Stem Cell Therapy”

  1. I have been told I have ms,then told cadasil too.now I had a stroke and the doctor said I could only have one.other dr. say I have both.i just asked my brother to have his blood tested,im 67 he is 69.he said he would. I was told only one person lived to be 69.my mom lived to be 71,but my dad died at 37 of cancer. my doctor said if I have my brother will have it.my mri said neither ms orcadasil could be ruled out.my cousin died with ms. please let me know what you think.my right side of my body is worse than my left,my rt. leg is heavy & poor circulation,&my head[the top ] burns. from-meredith ann sweat

  2. I was recently diagnosed with CADASIL. I am very interested in whatever treatment you could help me with. Willing to try

  3. I am from India, 45 and diagnosed with CADASIL. Both my siblings too have been diagnosed with CADASIL too. I would welcome any treatment related to stem cell therapy…

    1. My stem cell technology has break through and cure more than 20 kinds of diseases of difficulty and some types of cancers. Cadasil will be improved or cured by my technology. I have landed the award of Leader in Stem Cell Therapy.

      1. My stem cell technology has break through and cure more than 20 kinds of diseases of difficulty and some types of cancers. Cadasil will be improved or cured by my technology. I have landed the award of Leader in Stem Cell Therapy.

  4. Dear Dr. Madan Mohan
    I am interested in a cure for CADASIL as well, and am also interested in understanding how prevalent it is in South Asia. Do you happen to know the specific exon in Notch-3 that your mutation is in, and the mutation type and location?

  5. I ALONG SO FAR WITH MY SISTER, HAVE BEEN DIAGNOSED WITH CADASIL. MY TWO OTHER SIBLINGS MOST DEFINATELY ALSO HAVE IT AS WELL. ANY RESEARCH OR STATUS FOR THE CURE WILL BE AMAZING, AS MY TWO CHILDREN MOST LIKELY WILL HAVE IT AS WELL. I AM THE 2ND CHILD OF MY MOTHERS’ THAT HAS BEEN DIAGNOSED SINCE HER DEATH IN 2004 DUE TO CADASIL AT AGE 68

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