Pilot Safety and Efficacy Study of Isolagen Therapy in Treatment of Restrictive Burn Scars

Exclusion Criteria

• •The restrictive burn scar to be treated is primarily classified as a keloid scar
• •Surgical release of scar to be treated within the last 12 months
• •Subjects for whom a skin biopsy cannot be collected
• •Plans to initiate any new scar therapy during the study period
• •Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study
• •History of active autoimmune disease or organ transplantation
• •Diagnosis of cancer, including basal cell carcinoma, unless successfully treated or in remission for a minimum of 6 months
• •Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, epidermolysis bullosa, ataxia-telangiectasia, or Ehlers Danlos syndrome
• •Active systemic infection as shown by any one of the following: symptoms, fever and/or an elevated white count (subjects who present with an active systemic infection may be enrolled and biopsied after the infection has resolved)
• •Requires chronic antibiotic or steroidal therapy
• •Any conditions that are considered by the Investigator to be contraindications to biopsy or injection
• •Pregnant or lactating women or women trying to become pregnant during the study
• •Subject has any disorder that may prevent compliance, such as history of chronic alcohol or drug abuse, significant mental or nervous disorder or other illness that would, in the Investigator's opinion, interfere with the study
• •Presence of other disease or condition that would result in impairment of the range of motion of the extremity, e.g. rheumatoid arthritis or stroke
• •Subjects with a known allergy to gentamycin or amphotericin B, or sensitivity to materials of bovine origin