ACCS (Amnion-Derived Cellular Cytokine Solution) Versus Standard Care In Treating Partial Thickness Burns - Full Text View

Sponsored by:	Stemnion, Inc.
Information provided by:	Stemnion, Inc.
ClinicalTrials.gov Identifier:	NCT00886470

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 I Phase II

MedlinePlus related topics: Burns

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	99
Study Start Date:	May 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.
3: Experimental 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:

ACCS 0.01 mL/cm2 every 7th day vs. normal saline 0.01 mL/cm2 every 7th day;
ACCS 0.01 mL/cm2 every 4th day vs. normal saline 0.01 mL/cm2 every 4th day; and
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 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A signed IRB- approved Informed Consent Form;
18 - 40 years of age;
Two (2) similar, non-contiguous, partial-thickness burn wounds between 50 cm2 and 225 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 >225 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886470

Contacts

Contact: Martin C Robson, MD	412-770-1622	mcrobsonii@gmail.com
Contact: Jim Byrnes, MBA	412-770-1622	jbyrnes@stemnion.com

Locations

United States, Alabama
Regional Burn Center University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
United States, California
Southern California Regional Burn Center at LAC & USC Medical Center
Los Angeles, California, United States, 90033
UCSD Burn Center
San Diego, California, United States, 92103-8896
United States, Florida
Shands Burn Center, University of Florida College of Medicine
Gainsville, Florida, United States, 32610
University of South Florida Department of Plastic Surgery
Tampa, Florida, United States, 33606
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kentucky
University of Kentucky Hospital Burn Unit
Lexington, Kentucky, United States, 40536
United States, Maryland
Johns Hopkins Burn Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Brigham andWomen's Hospital Burn Center
Boston, Massachusetts, United States, 02115
United States, Missouri
Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, New York
Strong Memorial Hospital, University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Metro Health Medical Center
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Western Pennsylvania Burn Center
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 Chair:

Martin C Robson, MD

Stemnion, Inc.

More Information

No publications provided

Responsible Party:	Stemnion, Inc ( Martin C. Robson, MD Medical Monitor )
Study ID Numbers:	ACCS-PT-09.001
Study First Received:	April 22, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00886470 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Stemnion, Inc.:

cytokines
pain
scarring
vascularity

Study placed in the following topic categories:

Burns
Wounds and Injuries
Mitogens

Disorders of Environmental Origin
Pain
Cicatrix

Additional relevant MeSH terms:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 06, 2009