ACCS (Amnion-derived Cellular Cytokine Solution) Versus Standard Care In Treating Partial Thickness Burns

This study has been terminated.
(This study was terminated early due to slow accrual of patients.)
Sponsor:
Information provided by (Responsible Party):
Stemnion, Inc.
ClinicalTrials.gov Identifier:
NCT00886470
First received: April 22, 2009
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

The objective of this protocol is to perform a safety and dose-determination efficacy clinical trial in patients having a degree of partial-thickness burn wounds. The trial will be a prospectively randomized and double-blind trial of Amnion-derived Cellular Cytokine Solution (ACCS) compared with standardized care using 0.9% NaCl (normal saline) solution in the same three treatment regimens.


Condition Intervention Phase
Burns
Biological: ACCS (Amnion-derived Cytokine Suspension)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I/II Randomized Blinded Safety and Dose-determining Efficacy Trial Comparing Accs (Amnion-derived Cellular Cytokine Solution) in 3 Different Regimens With Standardized Care 0.9% Nacl in the Topical Treatment of Partial-thickness Burns

Resource links provided by NLM:


Further study details as provided by Stemnion, Inc.:

Primary Outcome Measures:
  • The primary endpoint will be the percentage of each wound that has epithelialized during the 21-day treatment period comparing the ACCS-treated wound with the saline-treated wound. [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of totally epithelialized (100%) wounds in the ACCS-treated wounds versus the number in the normal saline-treated wounds [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • The percentage conversion to full-thickness wounds in the ACCS-treated wounds versus the conversion in the normal saline-treated wounds [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Quality of healing, including pruritis, and scar hypertrophy, and reduction in pain in the ACCS-treated wounds as compared to saline-treated wounds [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Quality of healing as assessed by hemoxylin and eosin staining of the punch biopsy taken on Day 21 in the ACCS-treated wounds as compared to saline-treated wounds [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Assessment of change in arterial circulation using a laser Doppler from baseline to Day 21 in the ACCS-treated wounds as compared to saline-treated wounds [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Determination of levels of 6 cytokines present in blood prior to treatment (baseline) and within one-hour of the first treatment for the initial 12 patients [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • The primary safety endpoint will be the incidence of adverse events post-treatment. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Treatment every other day
Biological: ACCS (Amnion-derived Cytokine Suspension)
ACCS is a clear liquid containing more than 200 proteins, cytokines, and growth factors in solution. Patients will be treated for 21 days unless both wounds have healed prior to 21 days, at which time a punch biopsy of the epithelialized area of each wound will be performed. A study evaluation visit for assessment of the biopsy site will occur on day 28 or within 7 days of the punch biopsies, whichever occurs first. Six months after the punch biopsy, the patient will return to the burn center for a final examination and photographs of the study wounds.
Experimental: 2
Treatment every 4th day
Biological: ACCS (Amnion-derived Cytokine Suspension)
ACCS is a clear liquid containing more than 200 proteins, cytokines, and growth factors in solution. Patients will be treated for 21 days unless both wounds have healed prior to 21 days, at which time a punch biopsy of the epithelialized area of each wound will be performed. A study evaluation visit for assessment of the biopsy site will occur on day 28 or within 7 days of the punch biopsies, whichever occurs first. Six months after the punch biopsy, the patient will return to the burn center for a final examination and photographs of the study wounds.
Experimental: 3
Treatment every 7th day
Biological: ACCS (Amnion-derived Cytokine Suspension)
ACCS is a clear liquid containing more than 200 proteins, cytokines, and growth factors in solution. Patients will be treated for 21 days unless both wounds have healed prior to 21 days, at which time a punch biopsy of the epithelialized area of each wound will be performed. A study evaluation visit for assessment of the biopsy site will occur on day 28 or within 7 days of the punch biopsies, whichever occurs first. Six months after the punch biopsy, the patient will return to the burn center for a final examination and photographs of the study wounds.

Detailed Description:

A Phase I/II multi-center clinical trial will be performed in 99 adults with partial-thickness burns. Two similar partial-thickness burn areas in a single patient will be selected. One burn will be randomly assigned to receive either test drug (ACCS) or normal saline in one of three treatment regimens.

The three treatment arms will be:

  1. ACCS 0.01 mL/cm2 every 7th day vs. normal saline 0.01 mL/cm2 every 7th day;
  2. ACCS 0.01 mL/cm2 every 4th day vs. normal saline 0.01 mL/cm2 every 4th day; and
  3. ACCS 0.01 mL/cm2 every other day vs. normal saline 0.01 mL/cm2 every other day.

Two different preclinical studies of partial-thickness burns on guinea pigs have demonstrated accelerated epithelialization with topical treatment with ACCS. Similarly, preclinical studies in Yorkshire pigs have demonstrated more rapid maturity of epithelialization and better quality healing of partial-thickness skin graft donor sites with ACCS treatment.

In the preclinical studies, ACCS given in a dose of 0.01 mL/cm2 wound area appeared to saturate the wound adequately without excess and simultaneously improve healing. In preclinical toxicity studies, the dose of 0.01 mL/cm2 was shown to be safe.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A signed IRB- approved Informed Consent Form;
  • 18 - 65 years of age;
  • Two (2) similar, non-contiguous, partial-thickness burn wounds between 50 cm2 and 250 cm2 in area with blisters removed in a Total Body Surface Area(TBSA) burn of less than or equal to 40% TBSA;
  • Burns must be thermal burns of flame or scald etiology;
  • Patient must present to the burn center within 8 hours of injury;
  • Normal creatinine and bilirubin levels;
  • If capable of bearing children, patient must be using a medically accepted means of birth control and have a negative serum pregnancy test;
  • Willing to participate in the clinical study and comply with the requirements of the trial.

Exclusion Criteria:

  • The two (2) chosen wounds must not be full-thickness (extending through the dermis into the subcutaneous tissue);
  • Thermal burn from chemical, electrical or radiation causes;
  • Neither the study wound nor the comparator wound can be < 50 cm2 or >250 cm2 in size and cannot be on the face or hands;
  • Patients with significant pulmonary injury, i.e., smoke inhalation injury requiring ventilator support;
  • Patients with diabetes;
  • Patients with any immune deficiency including current treatment with corticosteroid medication, chemotherapeutic agents, anti-viral therapy, or concurrent radiation therapy within 30 days of signing the informed consent;
  • Abnormal bilirubin, liver function studies (i.e., AST, ALT> 2.0 times normal);
  • Abnormal serum creatinine, receiving hemodialysis or peritoneal dialysis;
  • Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (history of basal cell carcinoma is allowed);
  • 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.
  • Patients whose burns were previously treated with anything other than ice, cold water or dry dressing.
  • Participation in an investigational trial within 30 days of study entry.
  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: NCT00886470

Locations
United States, Alabama
University of South Alabama Dept. of Surgery
Mobile, Alabama, United States, 36617
United States, California
LAC - USC Medical Center
Los Angeles, California, United States, 90033
United States, Florida
Shands Burn Center at the University of Florida
Gainsville, Florida, United States, 32610
University of South Florida / Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kentucky
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0284
United States, Maryland
Johns Hopkins Burn Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
John S. Dunn Sr. Burn Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Stemnion, Inc.
Investigators
Study Director: David L Steed, MD Stemnion, Inc.
  More Information

No publications provided

Responsible Party: Stemnion, Inc.
ClinicalTrials.gov Identifier: NCT00886470     History of Changes
Other Study ID Numbers: ACCS-PT-09.001
Study First Received: April 22, 2009
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Stemnion, Inc.:
cytokines
pain
scarring
vascularity

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014