ISCO Doses First Patient Of Third Cohort In Parkinson's Clinical Trial.
The operation was performed at the Royal Melbourne Hospital (RMH) in Melbourne, Australia, by RMH neurosurgeons. The surgery proceeded with no complications and the patient was discharged soon after.
Parkinson's disease is a degenerative disorder of the central nervous system mainly affecting the motor system. The motor symptoms of Parkinson's result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain.
Prior to the surgery, a Data and Safety Monitoring Board (DSMB) meeting was held in which board members reviewed cumulative safety data of the first and second cohorts and determined that it was safe to proceed to the third cohort.
All four patients from the first cohort have entered the follow-up phase while three patients from the second cohort have completed the six-month evaluation.
The study will conclude following the dosing of the last three patients of the third cohort, which ISCO plans to complete in 2018.
Previously, the company announced interim results of the clinical trial at the American Academy of Neurology annual meeting.
The percent OFF-Time--the time of day when levodopa medication is not performing optimally and Parkinson's disease symptoms return--decreased an average of 24 percent for the first cohort at six months post-transplantation.
The percent ON-Time without dyskinesia--the time of day when levodopa medication is performing optimally without dyskinesia--increased an average of 19 percent for the first cohort during the same period.
All of the patients improved or retained the same cognitive abilities with an average improvement of 14 percent in the Cognitive Impairment dimension of the PDQ-39.
The company said the patient received the highest dose of ISC-hpNSC cells, and the therapy appeared safe and well-tolerated.
There are encouraging signs of improvement that are dose-dependent, with atients with higher dosage performing better on average than patients with lower dosage.
The Phase 1 clinical study is a dose escalation safety and preliminary efficacy study of ISC-hpNSC, intracranially transplanted into patients with moderate Parkinson's.
The open-label, single center, uncontrolled clinical trial will evaluate three different dose regimens of 30,000,000 to 70,000,000 neural cells.
Twelve participants with moderate-to-severe Parkinson's 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.
A PET scan will be performed at baseline, as part of the screening assessment, and at 6 and 12 months after surgical intervention.
Clinical responses compared to baseline after the administration of ISC-hpNSC will be evaluated using various neurological assessments such as Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr and other rating scales. An extension phase of the study will evaluate patients every 6 months for 5 additional years.
Early in the course of Parkinson's, the most obvious symptoms are movement-related.
These symptoms include shaking, rigidity, slowness of movement and difficulty with walking and gait.
Later, thinking and behavioral problems may arise, with dementia commonly occurring in the advanced stages of the disease, and depression as the most common psychiatric symptom.
Parkinson's is more common in people over the age of 50.
There are no approved treatments that restore the damaged dopaminergic neurons. Medications typically used in the treatment of Parkinson's disease, levodopa and dopamine agonists, improve the early symptoms of the disease.
As the disease progresses and dopaminergic neurons continue to be lost, the drugs eventually become ineffective, while at the same time frequently producing a complication marked by involuntary writhing movements. More than 10 million people are afflicted worldwide.
In 2013 Parkinson's resulted in about 103,000 deaths globally, up from 44,000 deaths in 1990.
ISCO's ISC-hpNSC comprises a highly pure population of neural stem cells derived from human parthenogenetic stem cells. It is a suspension of clinical grade cells manufactured under cGMP conditions that have undergone stringent quality control measures and are clear of any microbial and viral contaminants.
http ://www. international stemcell. com
|Printer friendly Cite/link Email Feedback|
|Title Annotation:||Clinical Trials|
|Publication:||Stem Cell Business News|
|Date:||Jun 25, 2018|
|Previous Article:||Positive Two-Year Safety Data From Diabetes Trial Presented.|
|Next Article:||Positive Six-Month Safety, Survival Rate Data From Phase 1 GvHD Trial.|