title: Safety Profile of Amnion-Derived Cellular Cytokine Solution (ACCS) Following Topical Skin Application in Patients Receiving Breast Radiotherapy.
abstract: OBJECTIVE
  To establish a safety profile for amnion-derived cellular cytokine solution following topical application in patients undergoing whole breast radiotherapy for breast cancer.
  
  
  METHODS
  Twenty female patients with early-stage breast cancer were enrolled in 2 separate cohorts of an institutional review board-approved phase I protocol. Cohort 1 consisted of 10 patients who received topical amnion-derived cellular cytokine solution to the breast immediately following the first 10 fractions of whole breast radiotherapy. Cohort 2 consisted of 10 additional patients who fit the same criteria as the initial cohort but received topical amnion-derived cellular cytokine solution following the development of at least grade I breast erythema. Blood samples were tested for the presence of proteins in amnion-derived cellular cytokine solution as well as routine hematologic functions.
  
  
  RESULTS
  Amnion-derived cellular cytokine solution did not induce overproduction of any cytokines sampled, and there was no evidence of "cytokine storm." It also showed no significant absorption systemically following topical delivery. No patients developed an adverse event. There were no patterns of changes in vital signs or clinical laboratory tests that were related to the treatment regimen.
  
  
  CONCLUSIONS
  In this safety trial, the topical application of amnion-derived cellular cytokine solution in both intact and denuded, irradiated skin was found to be safe, and showed no evidence of systemic absorption. No cosmetic changes were identified long term. Patient blood chemistry was not adversely affected, indicating the absence of an anaphylactic response and no evidence "cytokine storm" was identified. Amnion-derived cellular cytokine solution is safe to use topically in clinical protocols.
authors.affiliation: Department of Oncology, Allegheny General Hospital, Pittsburgh, Pa ; Department of Surgery, Allegheny General Hospital, Pittsburgh, Pa.
authors.forename: Mark
authors.initials: M
authors.lastname: Trombetta
authors.affiliation: Department of Surgery, Allegheny General Hospital, Pittsburgh, Pa ; Drexel University College of Medicine, Allegheny Campus, Pittsburgh, Pa ; National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, Pa.
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Julian
authors.affiliation: Drexel University College of Medicine, Allegheny Campus, Pittsburgh, Pa ; National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, Pa.
authors.forename: D Lawrence
authors.initials: DL
authors.lastname: Wickerham
authors.affiliation: Stemnion, Inc, Pittsburgh, Pa.
authors.forename: David L
authors.initials: DL
authors.lastname: Steed
keywords: breast; cytokine; dermatitis; radiation; skin reaction