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Clinical Trial Tests Cell Therapy for Vocal Cord Scarring

A clinical trial under way at the is testing an innovative, experimental therapy for dysphonia associated with vocal fold scarring and age-related vocal fold tissue changes. The industry-funded trial employs autologous fibroblasts harvested from post-auricular skin, which are then injected into the vocal fold.

The Voice Center is one of three sites nationwide participating in the phase II trial led by Exton, Pennsylvania–based Fibrocell Science. The company developed an autologous fibroblast technology platform, known as azficel-T, which enables clinicians to extract fibroblasts, cultivate them in the laboratory, and inject them into the patient’s vocal folds. The use of autologous cells decreases the chance of rejection by the immune system.

“Since current therapies only address poor vocal fold closure, but do not address the underlying issue of tissue changes, the clinical implications for this therapy could be quite significant,” says , associate professor of otolaryngology and associate director of the Voice Center. “Fibroblasts could potentially ‘regrow’ normal tissue and improve voice quality.”

The trial has enrolled 22 patients across 3 sites, including 8 patients at ������� Langone. Already FDA-approved for esthetic indications to improve the appearance of the nasolabial folds, the treatment is being tested for other medical uses, including burn scarring.

Study Develops First Models for Laryngeal Burn Injuries and Healing

Despite the fact that patients who survive inhalation burns are at risk for long-term voice and laryngeal dysfunction, most burn research focuses on acute lung injury. Supported by a grant from the American Laryngological Association, researchers at the Voice Center embarked on a study to better understand laryngeal burn injuries, with an eye toward development of improved treatments.

Under the leadership of Gregory R. Dion, MD, a fellow in laryngology at the Voice Center, a custom heat and smoke delivery device was created to quantify healing patterns in an animal model following different laryngeal burn exposures. Previously, no models existed to study these injuries and subsequent repair processes, likely underlying the lack of data to guide care in this challenging patient population. Dr. Branski and , associate professor of otolaryngology, chief of the Division of Laryngology, and director of the Voice Center, are mentors and co-investigators on the project.

By quantifying differences in injury and wound healing patterns as well as in the role of smoke exposure, the researchers hope to learn more about how inhalation burn injuries affect laryngeal tissues and function. The work will lay a foundation for future interventional studies, with the goal of improved treatments for this underserved population. Says Dr. Dion, “Our data will provide critical foundational information about the mechanisms underlying this specialized injury. It will provide a model for developing effective therapeutic approaches to improve and control the wound healing process.”