Ortec's FDA Approved Cell Line Plays Pivotal Role in Creation of Embryonic Stem Cell
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Ortec International, Inc. has announced that their collaboration with ES Cell International Pte, Ltd. (ESI), established in April 2004 in connection with the development of ESI's human embryonic stem cell (hESC) derived cell therapy products, has yielded its first significant milestone.
ESI recently announced that it has produced and stored what it believes to be the first clinically compliant human embryonic stem cell lines.
These cell lines were derived using feeder cells from viral-tested human cells rather than mouse cells, and, therefore, should be able to be used in human clinical trials to develop novel stem-cell therapies.
The feeder cells used by ESI in developing these cell lines were manufactured by Ortec and are FDA approved and manufactured under Good Manufacturing Practices.
Ortec is one of the few companies that has ever received FDA approval to use allogeneic cell lines (derived from third party donor cells) for cell therapy.
Ortec produces, develops, and manufactures cell lines for use in OrCel®, its cellular product for accelerated skin regeneration in chronic and acute wounds.
Under the terms of the April 2004 agreement, ESI paid Ortec upfront payments for the right to use one of Ortec's cell lines.
Ortec is entitled to receive future payments on the achievement of milestones in ESI's human ES cell derived cell therapy programs, as well as payment of royalties for future commercial sales of ESI's cell therapy products.
Ron Lipstein, Vice Chairman and CEO of Ortec, said, "We are glad that our FDA approved cell line has so significantly contributed to the achievement of ESI's important milestone towards the goal of development of new cell therapies."
