NZ Parkinson's trial on hold – experts respond

An Auckland biotech company is putting its trial of an experimental Parkinson's disease treatment on hold following the withdrawal of previous animal research.

Living Cell Technologies (LCT) has suspended patient recruitment for a clinical trial testing the xenotransplantation of specially encapsulated pig-derived cells (NTCELL) as a treatment for Parkinson's disease.

Earlier research from the company had shown the implanted cells were effective in treating animal models of Parkinson's disease in rats and monkeys. However, following the discovery that the original data from rat study was incomplete, LCT has retracted the study, published in the journal Regenerative Medicine.

"The publication is being withdrawn following an internal quality assurance audit which showed that the source data for the study held on file at LCT are incomplete and therefore the efficacy conclusions in the publication cannot be confirmed," the company said in a press release.

In the light of the retraction LCT, which is a listed company on the Australian stock exchange, announced its early stage human trial taking place at Auckland hospital would not be recruiting further patients. One patient is already taking part in the trial and will continue treatment as planned.

The company said this was a "precautionary measure" to "allow the company to work with the New Zealand medicines regulator (Medsafe) and the data safety monitoring board (DSMB) to fully understand the impact of the withdrawal of the rat efficacy data on the Phase I clinical trial."

A full record of the planned NTCELL trial can be found on the US clinical trials registry, clinicaltrials.gov.

The Science Media Centre has rounded up reaction from experts:

Professor Gareth Jones, Bioethics Centre, University of Otago, comments:

"Transplantation of neural grafts into patients with Parkinson's Disease has had a long and unsatisfactory history, even though it was originally based on well conducted and encouraging studies in animals. In light of this it behoves any new procedures to be exceedingly careful and rigorous about the pre-clinical work undertaken on animal models. This is essential since the transplantation is into patients with a debilitating neurological disease, and who expect to benefit from these procedures, and are not simply treated as experimental subjects.

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NZ Parkinson's trial on hold - experts respond