Study of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline in Treating Skin Irritation From Radiation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01714973
Recruitment Status : Unknown
Verified January 2015 by Noveome Biotherapeutics, formerly Stemnion.
Recruitment status was:  Active, not recruiting
First Posted : October 26, 2012
Last Update Posted : January 16, 2015
Information provided by (Responsible Party):
Noveome Biotherapeutics, formerly Stemnion

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Radiation-induced Dermatitis Biological: ACCS Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ACCS
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.
Biological: 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.
Other Name: Amnion-derived Cellular Cytokine Solution (ACCS)

Primary Outcome Measures :
  1. Adverse Events (AEs) and Significant Adverse Events (SAEs) [ Time Frame: Start of therapy through six week follow-up visit ]

Secondary Outcome Measures :
  1. Skin inflammation [ Time Frame: start of therapy through six week follow-up visit ]
  2. Quality of life [ Time Frame: start of therapy through one year follow-up ]

Other Outcome Measures:
  1. Cosmesis [ Time Frame: 6 and 12 months post-treatment ]
    Cosmesis will be evaluated by photography and investigator assessment using the cosmesis form in National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-39, A Randomized Phase III Study of Conventional Whole Breast Irradiation Versus Partial Breast Irradiation for Women with Stage 0, I, or II Breast Cancer. The following factors will be evaluated in the skin: telangiectasia, atrophy, scarring, pigmentation, erythema, fat necrosis, and fibrosis.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01714973

United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Noveome Biotherapeutics, formerly Stemnion
Principal Investigator: Mark Trombetta, MD West Penn Allegheny Health System
Study Director: David L Steed, MD Noveome Biotherapeutics, formerly Stemnion

Responsible Party: Noveome Biotherapeutics, formerly Stemnion Identifier: NCT01714973     History of Changes
Other Study ID Numbers: ST-02-12
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Skin Diseases
Radiation Injuries
Wounds and Injuries
Pharmaceutical Solutions