A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids

Exclusion Criteria

• •Subject is suffering from a condition likely to require medical attention, including administration of any treatment which in the opinion of the Investigator could influence the results of the study.
• •Subject with any systemic condition like uncontrolled diabetes mellitus (glycosylated hemoglobin, HbA1C \> 10%), cancer (biopsy confirming active malignancy), positive HIV test, or any disorder(s) that may compromise wound healing.
• •Subject is suffering from an abnormal skin condition on the affected area not usually associated with keloids such as psoriasis, or eczema.
• •Subject who is currently or has received topical or systemic steroid medication therapy within the past four weeks affecting the course of the keloid and/or its evaluability. Inhaled steroid therapy is acceptable.
• •Subject with the presence of acute infections in the areas intended for treatment.
• •Subject with known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
• •Subject who is lactating or pregnant (positive result as determined by urine testing).
• •Subject with liver (ALT/SGPT, ALP, AST/SGOT, bilirubin, albumin, total protein, LDH) and/or renal function (BUN and creatinine) tests \> 2 x upper limit of normal (ULN).
• •Subject who has been previously enrolled in any wound or investigational device study for any disease within the past four weeks.
• •Subject who has received an investigational drug or biological treatment within the past three months.
• •Subject previously treated with Apligraf, Dermagraft or any other cell therapy at the target keloid site.
• •Subject with a history of alcohol or substance abuse within the previous year, which could interfere with study compliance such as inability to attend scheduled study visits or compliance with home dressing changes.
• •Subject with a history of anaphylaxis.
• •Subject who, in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol