Marrow-Tech Inc. on Monday announced initial results fromclinical tests of its living skin replacement, which isperforming well in helping to heal burns without promptingrejection.
The results, presented Saturday at the InternationalSymposium on Wound Healing and Wound Management inChicago, showed that the living dermal replacement can allowconsistent growth of a patent's own skin over the graft,without infection or evidence of rejection by the immunesystem.
To date, more than 30 patients have received the skin graft totreat burns, with a total of 125 to be enrolled before Marrow-Tech files for pre-market approval. Dermagraft will also betested in treating venous skin ulcers.
The company has requested permission from the Food and DrugAdministration to expand the skin graft trials to 24 from 12centers, and plans to file for a supplement to itsinvestigational device exemption to study the graft'seffectiveness in pressure sores.
The La Jolla, Calif., company's stock ((NASDAQ:MAROA) closedMonday at $14, down 75 cents.
Marrow-Tech recently released preclinical data on its liver,bone marrow and skin systems, all grown with a proprietarythree-dimensional culture method.
Company scientists told a meeting of the BiomedicalEngineering Society on Oct. 12 that liver cells grown with thetechnique are able to retain enzyme synthesis and drugmetabolism capabilities for at least six weeks, compared withthe usual 72 hours for conventionally cultured hepatocytes.
Marrow-Tech's bone marrow cultures can support growth ofnatural killer cells for at least 75 days, they reported, withgreater cell-killing activity than conventional means ofnurturing these immune cells in vitro.
The company has not set a start date for clinical trials.Natural killer cells are targeted toward cancers, while theliver cells first will be studied as a system for drugdevelopment, with an eye toward potential transplantapplications, said Gail K. Naughton, executive vice president. -- Roberta Friedman, Ph.D.
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