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Regen Med. 2015 Nov;10(8):939-58. doi: 10.2217/rme.15.57. Epub 2015 Sep 8.

Preclinical safety of human embryonic stem cell-derived oligodendrocyte progenitors supporting clinical trials in spinal cord injury.

Author information

1
Geron Corporation, 149 Commonwealth St., Menlo Park, CA 94025, USA.
2
California Institute of Regenerative Medicine, 210 King St., San Francisco, CA 94107, USA.
3
Asterias Biotherapeutics Inc., 230 Constitution Drive, Menlo Park, CA 94025, USA.
4
Dark Horse Consulting, 1999 South Bascom Ave Suite 700, Campbell, CA 95008, USA.

Abstract

AIM:

To characterize the preclinical safety profile of a human embryonic stem cell-derived oligodendrocyte progenitor cell therapy product (AST-OPC1) in support of its use as a treatment for spinal cord injury (SCI).

MATERIALS & METHODS:

The phenotype and functional capacity of AST-OPC1 was characterized in vitro and in vivo. Safety and toxicology of AST-OPC1 administration was assessed in rodent models of thoracic SCI.

RESULTS:

These results identify AST-OPC1 as an early-stage oligodendrocyte progenitor population capable of promoting neurite outgrowth in vitro and myelination in vivo. AST-OPC1 administration did not cause any adverse clinical observations, toxicities, allodynia or tumors.

CONCLUSION:

These results supported initiation of a Phase I clinical trial in patients with sensorimotor complete thoracic SCI.

KEYWORDS:

biodistribution; clinical trial; human embryonic stem cells; oligodendrocyte progenitors; preclinical safety; thoracic spinal cord injury; toxicology; tumorigenicity

PMID:
26345388
DOI:
10.2217/rme.15.57
[Indexed for MEDLINE]
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