International Stem Cell Corp. (ISCO) Gets Regulato
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Posted On: 12/14/2015 3:28:22 PM
International Stem Cell Corp. (ISCO) Gets Regulatory Green Light to Begin Clinical Trial of ISC-hpNSC for the Treatment of Parkinson’s Disease
Currently available Parkinson’s disease treatments, while capable of improving the early symptoms of the disease, lose their effect as the disease progresses and produce involuntary writing movements in the patients. As of yet there is no cure for the disease, which is the second most common neurodegenerative disease and affects over 7 million people worldwide. International Stem Cell Corp. (OTC: ISCO), a leader in using pluripotent stem cells in regenerative medicine, this morning issued news regarding its stem cell technology – signaling a potential blockbuster shift it the treatment of Parkinson’s disease.
ISCO today announces that its wholly owned subsidiary, Cyto Therapeutics, has received regulatory approval by the Therapeutics Goods Administration (TGA) of Australia to initiate a phase I/IIa clinical trial, dose escalation trial of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) in patients with moderate to severe Parkinson’s disease.
“We are very pleased to start the first human study of ISC-hpNSC’s for the treatment of this debilitating disease. There is a large unmet medical need for new treatments that may halt or reverse the progression of Parkinson’s disease and we believe our human neural stem cells may fill this need for the millions of people with this disease” stated Andrey Semechkin, PhD, ISCO’s chief executive officer. “We look forward to reporting on the progress of the clinical trial over the coming months.”
ISCO last year announced positive results from its preclinical studies for its ISC-hpNSC therapeutic candidate. In those preclinical studies, the cells demonstrated an improvement in Parkinson’s disease symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC. The studies further noted that the ISC-hpNSCs provided neurotrophic support and cell replacement to dying dopaminergic neurons.
About the clinical study
The upcoming phase I/IIa clinical study – which will be performed at Royal Melbourne Hospital in Melbourne, Australia – is a dose escalation safety and preliminary efficacy study of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) intracranially transplanted into patients with moderate to severe Parkinson’s disease. The open-label, single center, uncontrolled clinical trial will evaluate three different dose regimens of 30 million-70 million neural cells. A total of 12 participants with moderate to severe Parkinson’s disease will be treated. Following transplantation, the patients will be monitored for 12 months at specified intervals, to evaluate the safety and biologic activity of ISC-hpNSC.
“We are the first company in the world to conduct clinical trials of human pluripotent stem cells based product for the treatment of Parkinson’s disease. We believe the outcome of the study will produce findings in-line with our preclinical studies, where we demonstrated not only safety of our proprietary neural stem cells, but also their functional efficacy. The cells were able to successfully integrate into the brain and provide a significant increase of dopamine levels in the nigrostriatal system” commented Russell Kern, PhD, ISCO’s executive vice president and chief scientific officer.
For more information, visit www.internationalstemcell.com
Please read full disclaimers at http://disclaimer.missionir.com
Currently available Parkinson’s disease treatments, while capable of improving the early symptoms of the disease, lose their effect as the disease progresses and produce involuntary writing movements in the patients. As of yet there is no cure for the disease, which is the second most common neurodegenerative disease and affects over 7 million people worldwide. International Stem Cell Corp. (OTC: ISCO), a leader in using pluripotent stem cells in regenerative medicine, this morning issued news regarding its stem cell technology – signaling a potential blockbuster shift it the treatment of Parkinson’s disease.
ISCO today announces that its wholly owned subsidiary, Cyto Therapeutics, has received regulatory approval by the Therapeutics Goods Administration (TGA) of Australia to initiate a phase I/IIa clinical trial, dose escalation trial of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) in patients with moderate to severe Parkinson’s disease.
“We are very pleased to start the first human study of ISC-hpNSC’s for the treatment of this debilitating disease. There is a large unmet medical need for new treatments that may halt or reverse the progression of Parkinson’s disease and we believe our human neural stem cells may fill this need for the millions of people with this disease” stated Andrey Semechkin, PhD, ISCO’s chief executive officer. “We look forward to reporting on the progress of the clinical trial over the coming months.”
ISCO last year announced positive results from its preclinical studies for its ISC-hpNSC therapeutic candidate. In those preclinical studies, the cells demonstrated an improvement in Parkinson’s disease symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC. The studies further noted that the ISC-hpNSCs provided neurotrophic support and cell replacement to dying dopaminergic neurons.
About the clinical study
The upcoming phase I/IIa clinical study – which will be performed at Royal Melbourne Hospital in Melbourne, Australia – is a dose escalation safety and preliminary efficacy study of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) intracranially transplanted into patients with moderate to severe Parkinson’s disease. The open-label, single center, uncontrolled clinical trial will evaluate three different dose regimens of 30 million-70 million neural cells. A total of 12 participants with moderate to severe Parkinson’s disease will be treated. Following transplantation, the patients will be monitored for 12 months at specified intervals, to evaluate the safety and biologic activity of ISC-hpNSC.
“We are the first company in the world to conduct clinical trials of human pluripotent stem cells based product for the treatment of Parkinson’s disease. We believe the outcome of the study will produce findings in-line with our preclinical studies, where we demonstrated not only safety of our proprietary neural stem cells, but also their functional efficacy. The cells were able to successfully integrate into the brain and provide a significant increase of dopamine levels in the nigrostriatal system” commented Russell Kern, PhD, ISCO’s executive vice president and chief scientific officer.
For more information, visit www.internationalstemcell.com
Please read full disclaimers at http://disclaimer.missionir.com
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