Human embryo stem cells: Asterias continues its trials



The Asterias company is carrying out a 1/2A clinical trial for patients presenting spinal cord injuries. This trial assess the safety and efficacy of AST-OPC1 therapy, which involves injecting these patients with neuronal precursors obtained from human embryo stem cells. In its last press release, Asterias announced that 67% of patients in the second cohort, i.e. 4 patients, witnessed an improvement in upper limb motor function over a period of 12 months [1]. The results obtained with cohorts 3 and 4 should be published in the next few months. Depending on the cohorts, patients received different doses of cells and presented with spinal cord injuries of varying severity. Thirty-five patients divided into four cohorts were enrolled in the trial.

 

At the same time, the company announced that the FDA [2] had granted "innovative therapy in regenerative medicine" status for its AST-OPC1 therapy. This will facilitate development of the treatment, which is now eligible for priority investigation, and speed up the marketing authorisation process.

 

For further reading: Human embryo stem cells and tetraplegia: miracle unravelled

 

[1] "Two or more levels of motor activity have been recovered, at least on one side, over a period of 12 months". "At least one side could carry out routine daily activities such as eating, dressing and bathing. This significantly reduced the overall need for patient assistance and the related health care costs".

[2] Food and Drug Administration.


Sources: 

Asterias (2/10/2017)