The Food and Drug Administration has approved OrganogenesisInc.'s supplemental investigational device exemption for humanclinical trials using Graftskin, the Canton, Mass., company saidTuesday.
Human clinical trials will be conducted at 10 sites with up to300 patients using Graftskin to treat skin wounds resultingfrom venous stasis disease.
As many as 900,000 people suffer each year in the U.S. fromvenous disease each year, which leads to venous ulcers causedby the pooling of blood in the lower leg and the eruption ofnon-healing wounds.
Graftskin is a full-thickness living skin equivalent now inhuman critical trials to treat severe burn victims and othersrequiring skin grafts.
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