A novel cell therapy using retinal pigment epithelial (ROE) cells attached to gelatine bead microcarriers implanted in the brain appears to improve moderate to advanced Parkinson's disease symptoms.

A pilot study followed six patients with moderate to advanced Parkinson's disease to investigate the safety, tolerability and efficacy of the Spheramine implantation which researchers hope will serve as a new potential source of levodopa to enhance dopamine production where it is most needed.

The investigating team from Rush University evaluated the full patient group for four years reporting a long-term improvement or stabilisation of symptoms apparent for two years after initial Spheramine implantation including tremor, rigidity, slowness of movements, and impaired balance and coordination.

The primary efficacy measure for the trial was the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS) when the patient has been off anti-parkinsonian medication for at least 12 hours.

Clinical improvements were noted in both UPDRS motor scores off medication (44 per cent improvement from baseline at 48 months) and patient-reported quality of life scores (23 per cent improvement from baseline of total PDQ-39 score at 48 months), researchers noted. The trial has now been extended to ten years of follow-up.

Researchers noted no serious adverse events, with the most frequent being post-surgical headache.

"The results of this study are very encouraging - Spheramine is well tolerated through several years of follow-up and improvement in parkinsonian symptoms is sustained," lead researcher Roy Bakay stated.

The positive results of this pilot study have now prompted the initiation of a Phase IIb, multicentre, double-blind, randomised, sham surgery-controlled study to further evaluate Spheramine.

Findings were presented at the Annual Meeting of the American Association of Neurological Surgeons in Chicago.

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