Study of ACCS (Amnion-derived Cellular Cytokine Solution) in Diabetic Subjects With Deep Burns Managed With Skin Grafts

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:
NCT01715012
First received: October 22, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

This study is a randomized, double blind, placebo controlled trial at a single site. The primary objective is to evaluate the safety of ACCS in diabetic subjects with deep burns. The secondary objectives of this study are to (1) evaluate efficacy of ACCS in healing burns and (2) evaluate whether treatment with ACCS results in less scarring, in subjects with diabetes separately comparing healing of the skin graft and the skin graft donor site using ACCS plus a burn dressing versus placebo and a burn dressing.


Condition Intervention Phase
Third Degree Burns in Subjects With Diabetes
Biological: ACCS
Biological: Saline (Placebo)
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: A Phase 2a Randomized, Double Blind, Placebo Controlled, Single-center Study of ACCS (Amnion-derived Cellular Cytokine Solution) Spray in Diabetic Subjects With Deep Burns Managed With Meshed Skin Grafts.

Resource links provided by NLM:


Further study details as provided by Stemnion, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Beginning at enrollment and continuing 12 months after last treatment ] [ Designated as safety issue: No ]
    The primary objective of this study is to evaluate the safety of ACCS in treating burns in diabetic subjects by evaluating adverse events and serious adverse events. Physical examination, hematology, serum chemistry, urinalysis, vital signs, Adverse Event monitoring, and concomitant medications, cytokine and antibody levels will be monitored at baseline and during the study.


Secondary Outcome Measures:
  • Healing of skin graft [ Time Frame: Up to 2 weeks of treatment ] [ Designated as safety issue: No ]
    Evaluation of ACCS compared with placebo (saline) in treating burns in diabetic subjects by assessing the time to complete healing of the skin graft.

  • Healing of skin graft donor site [ Time Frame: Up to 2 weeks of treatment ] [ Designated as safety issue: No ]
    Evaluation of ACCS compared with placebo (saline) in treating burns in diabetic subjects by assessing the healing of the skin graft donor site.

  • Scarring of skin graft [ Time Frame: One year following treatment ] [ Designated as safety issue: No ]
    Evaluation of ACCS compared with placebo (saline) in treating burns in diabetic subjects by assessing scarring of the skin graft at six months and one year using a validated scar scale.

  • Scarring of skin graft donor site [ Time Frame: One year following treatment ] [ Designated as safety issue: No ]
    Evaluation of ACCS compared with placebo (saline) in treating burns in diabetic subjects by assessing scarring of the skin graft donor site at six months and one year using a validated scar scale.


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACCS
ACCS sprayed to the skin graft and donor site
Biological: ACCS
Other Name: Amnion-derived Cellular Cytokine Solution
Placebo Comparator: Saline
Saline (placebo)sprayed to the skin graft and donor site
Biological: Saline (Placebo)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated Institutional Review Board-approved written Informed Consent
  • 18 - 75 years of age.
  • Thermal or scald burn, either full thickness or deep partial thickness, which in the opinion of the burn surgeon, requires a meshed skin graft to heal.
  • Target burn area for treatment equal to or less than three percent total body surface area.
  • A skin graft site harvested at 10/1000ths of an inch and a skin graft meshed at 2:1.
  • Total Body Surface Area (TBSA) burn of less than or equal to 20 percent total body surface.
  • Patient must have a known history of diabetes, or be found to have diabetes at the time of admission, confirmed by a Hemoglobin A1C of greater than 6.5 percent.
  • If a woman of child-bearing potential (WOCBP), she and her partner must be willing to employ either a highly effective form of birth control (e.g., implants, injectable medications, a hormone combination oral contraceptive, etc.), sexual abstinence, or a vasectomised partner, in combination with a barrier method, for the entire duration of the study (through study discharge). Male subjects with a WOCBP partner must be willing to use a condom during sexual activity for the entire duration of the study (through study discharge).
  • Willing to participate in the clinical study and comply with the requirements of the trial.

Exclusion Criteria:

  • Full thickness burns involving tendon, ligament, bone, or joint capsule.
  • Burns of the face, neck, palmer surface of the hands and plantar surface of the foot.
  • Burn from chemical, electrical or radiation causes.
  • Subjects 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.
  • Active cancer or a history of cancer in the five years prior to signing the informed consent form. (History of basal cell carcinoma is allowed).
  • Life expectancy of less than one year.
  • Patients requiring care in the Intensive Care Unit.
  • Inhalation injury requiring mechanical ventilation.
  • Multiple trauma (significant traumatic injury to a solid organ in addition to skin).
  • Psychiatric condition or substance abuse which in the Investigator's opinion may pose a threat to subject 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
  • Prisoners
  • Acute clinically significant infection (including viral infections) in the six weeks prior to administration of study drug or any clinically significant ongoing chronic infection (excluding fungal infections of the nail beds).
  • Evidence or history of skin conditions that would interfere with evaluations.
  • Any other uncontrolled concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study or interfere with the interpretation of study data.
  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: NCT01715012

Locations
United States, Ohio
The Burn Unit of the Wexner Medical Center at The Ohio State University. Recruiting
Columbus, Ohio, United States, 43210
Contact: Rebecca Coffey, MSN    614-293-6084    rebecca.coffey@osumc.edu   
Principal Investigator: Larry Jones, MD         
Sponsors and Collaborators
Stemnion, Inc.
Investigators
Principal Investigator: Larry Jones, MD Ohio State University
  More Information

No publications provided

Responsible Party: Stemnion, Inc.
ClinicalTrials.gov Identifier: NCT01715012     History of Changes
Other Study ID Numbers: ST-03-12
Study First Received: October 22, 2012
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stemnion, Inc.:
Burn
Diabetes
Skin graft
Donor site

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014