A cure for Parkinson’s Disease could be on the horizon after a research team was given permission to begin human clinical trials, it was revealed today.
The disease affects around 127,000 people in the UK and there is currently has no cure.
But the International Stem Cell Corporation (ISCO) has been granted authorisation to begin phase I/IIa clinical trials on 12 participants with moderate to severe Parkinson’s Disease.
The trials are the first on human guinea pigs and will look specifically look at dosage levels.
The participants will be given varying doses of neural stem cells and have their neurological condition monitored for 12 months.
But in a paper published in the Journal of Parkinson’s Disease, Roger Barker, PhD, from the John van Geest Centre for Brain Repair at the University of Cambridge has warned people to “react with caution”.
He said: “As with many such exiting news items, one should react with caution, especially since the outcome of this trial can affect the development of other stem cell programs moving towards clinical trials.”
The latest paper asks five key questions.
What is being transplanted, and what is the proposed mechanism of action?
What are the pre-clinical safety and efficacy data supporting the use of the proposed stem cell product?
Can arguments concerning ethics, risk mitigation, or trial logistics outweigh concerns regarding the expected efficacy of the cell and constitute a primary justification for choosing one cell type over another in a clinical trial?
What is being claimed regarding the potential therapeutic value of the stem cell-based therapy – better control of symptoms or a cure?
What is the regulatory oversight of the trial and is it guided by input from experts in the field?
Co-author of the paper and editor-in-chief of the Journal of Parkinson’s Disease, Patrik Brundin (doub corr), said: “This is an exciting prospect but should only be undertaken when all the necessary pre-clinical data and regulatory approvals have been obtained and verified and the criteria for moving those cells to trials fully resolved and met.
“Acting prematurely has the potential not only to tarnish many years of scientific work, but can threaten to derail and damage this exciting field of regenerative medicine.
“Hopefully, in 2016, we are ready to take a more careful approach as we strive to repair the PD brain with stem cell-based therapies, avoiding many of the mistakes that have dogged this field over the last three decades.”
By Taylor Geall