Fibrocell Science, Inc., a biotechnology company at the forefront of research into the potential medical and aesthetic use of fibroblasts, has planned to initiate a phase II clinical trial to assess the potential of azficel-T for treating restrictive burn scars in first quarter, 2013. Fibroblasts are skin cells responsible for the production of collagen that contribute to the formation of connective tissue fibers.
Fibrocell recently launched LAVIV (azficel-T), the first and only personalised cell treatment approved by the US FDA to improve the appearance of moderate to severe nasolabial folds or “smile line” wrinkles in adults.
Azficel-T has been evaluated in over 1,000 patients in well controlled clinical studies, including two pivotal phase III trials for licensed application. The restrictive burn scar trial will enroll 20 subjects who have unilateral restrictive burn scars of a jointed area, such as elbows, shoulders and fingers. Measurement scales will assess Range of Motion (ROM), Brief Pain Index and Scar Appearance.
Approximately 45,000 people in the US are hospitalized each year with severe burns. These patients are often left with restrictive burn scars that decrease mobility and cause continuous pain. “Indications are that fibroblasts, due to their inherent role in wound healing, have the potential to bring an increased quality of life to those patients who have long suffered from restrictive burn scars,” said Daniel Lozano, MD, principal investigator for the study. “This clinical trial has the potential to help validate this concept and bring physicians an effective treatment option for their patients.”
“This is an important step for Fibrocell Science,” said David Pernock, chairman and CEO of Fibrocell Science, Inc. “The clinical trial is part of the Company’s strategic plan to use its proprietary, collagen-producing fibroblast platform to address high-value, unmet medical needs.”
LAVIV is indicated for use for the improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. The safety and efficacy of LAVIV for areas other than nasolabial folds have not been established. The efficacy of LAVIV beyond six months has not been established.
LAVIV (azficel-T) is an autologous cellular product for intradermal injection only. LAVIV is contraindicated for allogeneic use, in patients with allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO) or material of bovine origin and in patients with active infection in the facial area. The following reactions have been reported following treatment with LAVIV: hypersensitivity reactions, bleeding and bruising at the treatment site, vasculitis, herpes labialis, basal cell cancer; keloid and hypertrophic scarring may occur following post-auricular skin biopsies or LAVIV injections. Additional warnings and precautions to be considered include the use of LAVIV in patients with genetic disorders or formation of normal collagen matrices and in immunosuppressed patients, or those patients undergoing chemotherapy for malignancies or receive immunomodulatory therapies for autoimmune diseases.
The most common adverse reactions, occurring in = one per cent of patients who receive LAVIV, were injection-site redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis and pruritus.
LAVIV is now available in major metropolitan areas throughout the US, exclusively through board-certified dermatologists and plastic surgeons who have been trained by Fibrocell Science, Inc. on the treatment process.