- About Parkinson's disease
- Product profile
- Development to date
- Future development
LCT 0.024 Last updated EOD 16th August 2019
The following fact sheets provide a summary of our current business and research pipeline.
Development to date
LCT commenced a Phase IIb study in March 2016. The study aims to confirm the most effective dose of NTCELL, define any placebo component of the response and further identify the initial target Parkinson’s disease patient sub group. The study is being led by Dr. Barry Snow at Auckland City Hospital.
At 26 weeks post treatment, there was no statistically significant difference between the group who received NTCELL and the patients who had the sham surgery.
At one year, efficacy data shows a statistically significant improvement in the patients that received 40 or 80 NTCELL capsules implantation to the putamen on both sides of the brain as compared to the placebo group that received sham surgery, as measured by the change in the Unified Parkinson’s Disease Rating Scale (UPDRS Part III in the off state). Post implant results of this trial will continue to be monitored in accordance with the study extension protocol.
Initial analysis of the 18 month data shows a statistically significant improvement (p = <0.05) in the UPDRS in the patients who received 80 NTCELL capsules implantation to the putamen on both sides of the brain as compared to the placebo group that received sham surgery. No benefit was observed when 120 NTCELL capsules were implanted, there being evidence of inflammation which may have compromised efficacy in this group.
At 24 months post implant the 4 people with Parkinson’s disease who received 80 capsules continue to show a benefit as measured by the change in the Unified Parkinson’s Disease Rating Scale (UPDRS Part III in the off state). This was greater than the 2 placebo group in that section of the trial, but not when compared to all the 6 placebo patients (4 from the other groups) in whom responses were quite varied. Recipients of 40 capsules showed no difference from placebo.
Two years after NTCELL implantation, the criteria of a successful Phase IIb trial were met: safety and dose responsive efficacy compared to a placebo group. Although successful, the small numbers in the trial necessitate a confirmative larger Phase III study. LCT, with specialist input from its expert Medical Advisory Board, is exploring the feasibility of a further study as it would require additional resources and clinical study design.
A Phase I/IIa clinical trial for NTCELL® for Parkinson’s disease was completed in June 2015.
The clinical trial was an open label investigation of the safety and clinical effect of NTCELL in four people who have been diagnosed with Parkinson’s disease for at least five years.
The study, conducted in New Zealand, met its primary endpoint of safety, showing NTCELL implantation was well tolerated, with no adverse events considered to be related to NTCELL. NTCELL implantation also improved clinical features of Parkinson’s disease in the four patients studied, as measured by validated neurological rating scales and questionnaires, with the improvement sustained at 26 weeks post-implant.
In pre-clinical trials we induced a Parkinson's-like disorder in non-human primates and then implanted a single dose of NTCELL into the damaged dopaminergic region of their brain. The subjects implanted with NTCELL showed improvements in both motor and cognitive functions compared to the controls. The improvements were sustained for at least six months (the end of the study). Histological analysis showed an increase in the density of dopamine-producing nerve fibres in the NTCELL subjects compared to the controls. There was no evidence of inflammation or any other adverse event.