This trial is active, not recruiting.

Condition radiation-induced dermatitis
Treatment accs
Phase phase 1
Sponsor Stemnion, Inc.
Start date October 2012
End date October 2015
Trial size 30 participants
Trial identifier NCT01714973, ST-02-12


The objective of this study is to evaluate the safety and efficacy of ACCS in treating radiation burns of the skin in patients undergoing treatments for breast cancer and to compare ACCS treated burns with those treated with saline placebo controls.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
There will be 3 treatment cohorts of 10 patients each. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The patient will be randomized before the first treatment to receive ACCS and saline, one to the medial segment and the other to the lateral segment. The randomization scheme will be equal in each of three cohorts. The first cohort will receive ACCS and saline beginning with the first radiation treatment, the second cohort will receive ACCS and saline beginning with the onset of erythema from the breast irradiation, the third cohort will receive ACCS and saline beginning with the onset of skin ulceration from the breast irradiation.
accs Amnion-derived Cellular Cytokine Solution (ACCS)
Patients will receive ACCS spray, to half the breast and saline to the other half (blinded) after each of ten consecutive radiation therapy treatments. ACCS and saline will be sprayed onto the breast to deliver 0.01 ml/cm2.

Primary Outcomes

Adverse Events (AEs) and Significant Adverse Events (SAEs)
time frame: Start of therapy through six week follow-up visit

Secondary Outcomes

Skin inflammation
time frame: start of therapy through six week follow-up visit
Quality of life
time frame: start of therapy through one year follow-up

Eligibility Criteria

Female participants from 18 years up to 80 years old.

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

Additional Information

Official title 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
Principal investigator Mark Trombetta, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Stemnion, Inc..