A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures

Exclusion Criteria

• •1. Subjects with previous use of cellular therapy (e.g. Isolagen) in the treatment area
• •2. Subjects with a known history of keloids
• •3. Subjects with a known history of bleeding disorders
• •4. Subjects who have facial restrictive scar deficits, not to exclude the neck area.
• •5. Subjects who have had contracture-release procedures in the treatment area within the previous six months
• •6. Subjects with a known allergy to any of the constituents of HypoThermosol-FRS
• •7. Subjects taking immunosuppressive therapy including systemic steroids will be excluded if they have received any dose \>7.5 mg of prednisone equivalent/day for more than one week within 90 days of the first treatment or planning immunosuppressive therapy at any time during the study (Intranasal/inhaled steroids are acceptable)
• •8. Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment
• •9. Subjects with a life expectancy of \<9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc)
• •10. Subjects with a history of hypersensitivity to additional study-associated drugs/therapies (e.g. isopropyl alcohol, EMLA cream, adrenaline, lidocaine, etc)
• •11. Subjects with planned major surgical intervention during the course of the study.
• •12. Subjects with known idiopathic or drug-associated coagulopathy
• •13. Subjects taking medicinal products known to reduce hemostasis (e.g. heparin, Coumadin, etc.) in the 2 weeks prior to commencing treatment or planning to take medicinal products known to reduce hemostasis during the 12 week study period
• •14. Subjects who have taken any other investigational product within 30 days prior to screening or planned use of any other investigational product during the study period.
• •15. Subjects who are pregnant, lactating, planning pregnancy and women of child-bearing potential who are not abstinent or practicing an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase
• •16. Subjects with abnormal blood biochemistry or any other abnormal laboratory finding considered clinically significant in that it would deem the subject inappropriate for surgical procedures, as determined by the investigator (i.e. CBC with Differential, platelets, comprehensive metabolic panel to include electrolytes, bun/creatinine, liver function test and coagulation tests).
• •17. Subjects who have, as determined by the investigator a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study (i.e. Type 1 and Type 2 diabetic patients) or any condition within the last 14 days requiring hospitalization or surgical intervention.
• •18. Subjects with evidence of any past or present clinically significant medical condition that would impair wound healing
• •19. Subjects with a known hypersensitivity to gentamycin, amphotericin B, Bovine serum or porcine products.
• •20. Subjects with known alcohol or narcotic drug dependency
• •21. Subjects with diagnosed autoimmune disorders known to affect wound healing, such as Systemic Lupus Erythematosis (SLE), psoriasis, infection and inflammation (seborrheic dermatitis).
• •22. Subjects receiving an immunosuppressive medication regime including transplant anti-rejection agents.
• •23. Subjects with an Axis II to diagnosis DSM-IV (e.g., Schizophrenia, Bipolar Disorder). Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion