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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Stemnion, Inc.
Sponsor:
Information provided by (Responsible Party):
Stemnion, Inc.
ClinicalTrials.gov Identifier:
NCT01714973
First received: October 16, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Radiation-induced Dermatitis
Biological: ACCS
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Stemnion, Inc.:

Primary Outcome Measures:
  • Adverse Events (AEs) and Significant Adverse Events (SAEs) [ Time Frame: Start of therapy through six week follow-up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Skin inflammation [ Time Frame: start of therapy through six week follow-up visit ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: start of therapy through one year follow-up ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Cosmesis [ Time Frame: 6 and 12 months post-treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714973

Contacts
Contact: David L Steed, MD 412-402-9926 dsteed@stemnion.com
Contact: Nia Tatsis, PhD 412-402-9972 ntatsis@stemnion.com

Locations
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Susan Hebda, BS, CCRC    412-359-4046    shebda@wpahs.org   
Sponsors and Collaborators
Stemnion, Inc.
Investigators
Principal Investigator: Mark Trombetta, MD West Penn Allegheny Health System
Study Director: David L Steed, MD Stemnion, Inc.
  More Information

No publications provided

Responsible Party: Stemnion, Inc.
ClinicalTrials.gov Identifier: NCT01714973     History of Changes
Other Study ID Numbers: ST-02-12
Study First Received: October 16, 2012
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Dermatitis
Radiodermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014