Asterias cleared for stem cell trial in spinal cord injury

The FDA clears Asterias Biotherapeutics (OTCPK:ASTY) to initiate a Phase 1/2a clinical trial of AST-OPC1 in patients with completed cervical spinal cord injury. The trial will assess the safety and activity of escalating doses of AST-OPC1, oligodendrocyte progenitor cells derived from human embryonic stem cells.

The agency approved the next trial phase based on the results of a five-patient Phase 1 trial who had neurologically complete thoracic spinal cord injury. Each patient received a dose of 2M AST-OPC1 cells and have been followed for two to three years. No serious adverse events have been observed.

The Phase 1/2a trial will involve doses up to 10x higher in patients with cervical spinal cord injury. Patient enrollment should commence in Q1 2015. The results will support a Phase 2b trial that will more thoroughly assess the safety and efficacy of AST-OPC1.

The California Institute for Regenerative Medicine awarded the company a grant of $14.3M to help fund the work.

Related tickers: (NYSEMKT:CUR) (NASDAQ:STEM)

Comments (2)
  • draland
    , contributor
    Comments (534) | Send Message
    Great to hear !!! 'We' as Regenerative Medicine investors should celebrate yet another trail blazer joining the fray ! Pave the path forward and make it impossible for the regressive minded to halt this science which incidentally IS THE FUTURE of Medicine !
    'Threat to STEM' ? Reason for 1M shares trading down today ? NOT !!! Seller's will regret letting go at $1.50's, wait, wait, wait.....................
    Oh and don't forget ACTC.................w... wait, wait.....................
    BTW, thanks to 'TOOSMART', I've accumulated 200K and counting of ACTC.
    ; )
    27 Aug 2014, 01:37 PM Reply Like
  • moneyjunky
    , contributor
    Comment (1) | Send Message
    whats your target ?
    4 Sep 2014, 01:56 PM Reply Like
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