First Human Implant of Regenerative Therapy in Parkinson’s Disease
Pioneering treatment uses ‘support’ cells for the brain (September 20)
The first patient has been successfully implanted in a phase I clinical trial of the regenerative cell therapy NTCELL (Living Cells Technology Limited) — a potential treatment for Parkinson’s disease (PD).
The pioneering brain surgery was conducted at Auckland City Hospital in New Zealand. A magnetic resonance imaging (MRI) scan taken the day after the surgery indicated that the NTCELL capsules have been implanted at their intended target.
The phase I clinical trial is an open-label investigation of the safety and clinical effect of NTCELL in four people who have been diagnosed with PD for at least 4 years. The first patient will be monitored for 2 months to confirm that no serious adverse events have occurred. At that time, the independent data safety monitoring board (DSMB) will consider the safety data and advise whether the implants for the remaining three patients can proceed.
In the clinical trial, NTCELL was injected under guidance by neuroimaging into the affected area of the human brain where substantial death of neurons and other cells had occurred. The cell therapy consists of choroid plexus cells, which are naturally occurring “support” cells for the brain. The implanted cells are coated to protect them from attack by the patient’s immune system.
The scientific basis for the phase I clinical trial in humans was established from a published preclinical study of NTCELL in a nonhuman primate model of PD. The preclinical results indicated that NTCELL can protect and regenerate brain tissue that would otherwise be lost, potentially delaying or even preventing the effects of PD.
Source: LCT; September 20, 2013.