Phase I Randomized, Blinded Safety and Efficacy Trial of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline Sprayed on the Breast of Women Undergoing Radiation Therapy for Breast Cancer After Surgical Removal of the Tumor

Inclusion Criteria:

- A signed IRB - approved Informed Consent;

- Women 18 - 80 years of age;

- Biopsy-proven diagnosis of breast cancer with the tumor surgically removed.

- Whole breast radiation with or without ipsilateral axilla radiation therapy
recommended by her radiation oncologist.

- If a woman is of child-bearing potential, she and her partner must use an effective
form of birth control.

- Willing to participate in the clinical study and comply with the requirements of the
trial.

Exclusion Criteria:

- Abnormal liver or kidney function studies being greater than 2x the upper limit of
normal.

- Patients on hemodialysis

- Psychiatric condition or substance abuse which in the Investigator's opinion may pose
a threat to patient compliance;

- History of non-compliance with treatment or clinical visit attendance.

- Participation in an investigational trial within 30 days of study entry.

- Women who are pregnant or lactating