In a breakthrough study published on ClinicalTrials.gov and conducted by International Stem Cell Corp., researchers have indicated that early tests of a stem cell therapy for Parkinson's could be safe.
"ISCO believes that a stem cell therapy for Parkinson's could be safe."
More trials need to be conducted – and will be – but early signs are especially encouraging for people who have Parkinson's.
Russell Kern, ISCO's executive vice president and chief scientific officer, was optimistic, reported the San Diego Union-Tribune, but he still displayed restraint when praising the study.
"At least we can say there are no adverse events," Kern said.
ISCO has conducted this experiment on one patient – a man in his 60s, and it's still in the Phase 1 clinical trial. The company plans to administer its second patient into the program in the coming weeks, and ultimately has a goal to test 12 people with Parkinson's.
Kern gave a presentation on the study at the Society for Neuroscience 2016 convention in San Diego.
ISCO didn't just admit any patients into the study. It had a number of inclusion (and exclusion) criteria that they had to meet first. Here are a few examples of criteria for inclusion:
- Had to be between 30 and 70 years old.
- Had to be taking certain drugs (such as an anti-parkinsonian treatment) for at least three months prior to trial. The exception was they could stay on this treatment during the trial.
- Had to have Parkinson's symptoms.
- Had to have a history of taking anti-parkinsonian treatment that included "sufficient doses of levodopa."
"Each will be treated with an injection of ISC-hpNSC."
As we noted, ISCO has plans to admit a total of 12 patients into the program. Each will be treated with an injection of ISC-hpNSC intracerebrally to the substantia nigra and striatum of the patient. The study's main objective is to assess how safe it is to transplant stem cells.
What is interesting is that ISCO has noticed signs of physical improvement in the study's first patient. His handwriting has improved. But researchers would have to conduct more testing (and possibly studies) to determine whether this therapy does in fact minimize Parkinson's symptoms.
The future of Parkinson's research
Without a doubt, this study (so far) is a huge leap for those in the scientific community studying the impact of stem cells on Parkinson's.
If the Phase 1 trial is deemed a success, ISCO will ask to conduct a Phase 2 trial in the U.S.
While scientists don't know what causes Parkinson's, they do know that it causes cells to die. When these neurons are lost, levels of the neurotransmitter dopamine also decrease. Stem cell therapies, such as the one being used in ISCO's experiment, help replace lost cells to increase dopamine levels.