Organogenesis, Inc. (Organogenesis), a company focused in bio-active wound healing, oral regeneration and bio-surgery, is planning to complete the trial entitled “A Prospective, Randomized, Controlled Pilot Study of CelTx (Apligraf) as an Alternative to Tissue From the Palate in the Treatment of Gingival Recession Requiring Root Coverage” for CelTx in March 2010. The aim of the trial is to evaluate CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. The study is expected to prove that CelTx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing. The study is being conducted in US.
The phase II randomized, open label, parallel assignment, safety/efficacy study is currently recruiting approximately 26 participants. The study principal investigator is Michael McGuire, DDS Perio Health Professionals, PLLC.
CelTx is a cellular construct, designed to deliver living cells to regenerate soft tissue in the mouth. CelTx contains and produces cytokines and growth factors to stimulate the patient’s own cells to regenerate new, healthy tissue. The product is constructed based on apligraf technology.