Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01858753
First received: May 10, 2013
Last updated: January 21, 2015
Last verified: January 2015
  Purpose

This Phase II, double-blind, randomized, placebo-controlled pilot study is designed to determine whether injection of autologous fibroblasts can increase the mobility (decrease the restriction) of burn scars. The study will assess the effects of azficel-T (autologous fibroblasts) in subjects who have a unilateral burn scar that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either:

  1. An axillary scar causing 20-60% restriction of shoulder adduction
  2. An anterior elbow scar causing 20-60% restriction of elbow extension
  3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension

Subjects will each receive 2 injections of azficel-T or placebo administered 14 days (± 7 days) apart (depending on cell availability) and will be followed for efficacy (including range of motion measurements, scar pain and ability to perform activities) to Visit 7 and for safety to Visit 9 at 1 year.


Condition Intervention Phase
Restrictive Burn Scars
Biological: Autologous fibroblasts
Biological: placebo sterile saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Randomized, Placebo-Controlled Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

Resource links provided by NLM:


Further study details as provided by Fibrocell Technologies, Inc.:

Primary Outcome Measures:
  • Range of motion (ROM) measurement of the affected joint [ Time Frame: 180 days after final treatment ] [ Designated as safety issue: Yes ]
    ROM will be measured in the affected joint using standard ROM measuring techniques. One (1) passive ROM measurement will be taken by the same person at each study visit. ROM will be measured using a goniometer. The percent restriction is calculated by dividing the goniometric angle measured on the affected joint by that measured on the unaffected contralateral joint (multiplied by 100).


Secondary Outcome Measures:
  • Safety evaluation [ Time Frame: 14, 30, 60, 90, 120, 180, 240, 360 days ] [ Designated as safety issue: Yes ]
    • Evaluation of any worsening of the burn scar-related condition
    • Incidence and severity of adverse events (AEs)

  • Scar pain as assessed by the subject using the modified Brief Pain Inventory (BPI) (0 to 10) scale [ Time Frame: Baseline, 14, 30, 60, 90, 120, 180 days ] [ Designated as safety issue: Yes ]
  • Daily activities as assessed by the subject using the Activities Assessment Scale (AAS) [ Time Frame: Baseline, 14, 30, 60, 90, 120, 180 days ] [ Designated as safety issue: Yes ]
  • Scar itching as assessed by the subject using a 0 to 10 scale [ Time Frame: Baseline, 14, 30, 60, 90, 120, 180 days ] [ Designated as safety issue: No ]
  • Global improvement as assessed by the Evaluator using a 0 to 10 scale [ Time Frame: Baseline, 14, 30, 60, 90, 120, 180 days ] [ Designated as safety issue: Yes ]
  • Scar appearance as assessed by the Evaluator using the Vancouver Scar Scale (Burn Scar Index) [ Time Frame: Baseline, 14, 30, 60, 90, 120, 180 days ] [ Designated as safety issue: Yes ]
  • Productivity impairment assessed by the subject using the Work Productivity and Activity Impairment Questionnaire (WPAI) [ Time Frame: Baseline, 14, 30, 60, 90, 120, 180 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 21
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous fibroblasts
Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.
Biological: Autologous fibroblasts
Other Name: Azficel-T
Placebo Comparator: Sterile saline
Sterile saline will be injected into the scar to be evaluated.
Biological: Autologous fibroblasts
Other Name: Azficel-T
Biological: placebo sterile saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is at least 18 years of age
  2. Subject has a unilateral burn scar of a jointed area (i.e., finger, elbow, shoulder) that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either:

    1. An axillary scar causing 20-60% restriction of shoulder abduction
    2. An anterior elbow scar causing 20-60% restriction of elbow extension
    3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension
  3. Subject's burn scar to be treated is <100 sq cm in size
  4. Injury occurred ≤ 36 months prior to screening
  5. By the Investigator's assessment, physical therapy will not provide significant continuous improvement to the range of motion of the subject's joint
  6. Subject agrees to maintain any current physical therapy regimen for the duration of the study
  7. Subject must be able to provide written informed consent and comply with the study requirements
  8. Females of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to the first treatment, and must agree to use a reliable means of birth control for the duration of the study
  9. Subject has healthy, non-scarred post auricular skin area suitable for biopsy
  10. Subject must have a normal complete blood count (CBC) and chemistry panel within 90 days prior to enrollment

Exclusion Criteria:

  1. Restrictive burn scars that are primarily classified as keloid scars
  2. Subjects for whom a post auricular biopsy cannot be collected for azficel-T production
  3. Sunburn or sun damage in the area that will be used for biopsy
  4. Plans to initiate any other new scar therapy during the study period
  5. Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study
  6. History of active autoimmune disease or organ transplantation
  7. Diagnosis of cancer, including basal cell carcinoma, unless successfully treated or in remission for a minimum of 6 months
  8. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, epidermolysis bullosa, ataxia-telangiectasia, Ehlers Danlos syndrome, etc.
  9. Active systemic infection
  10. Requires chronic antibiotic or steroidal therapy
  11. Any conditions that are considered by the Investigator to be contraindications to biopsy or injection
  12. Pregnant or lactating women, or women trying to become pregnant during the study
  13. Subject has any disorder that may prevent compliance, such as history of chronic alcohol or drug abuse, significant mental or nervous disorder or other illness that would, in the Investigator's opinion, interfere with the study
  14. Presence of other disease or condition that would result in impairment of the range of motion of the extremity, e.g., rheumatoid arthritis or stroke
  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: NCT01858753

Locations
United States, California
Univ of California David Medical Center
Sacramento, California, United States, 95817
Univ of California San Diego
San Diego, California, United States, 92103
United States, Florida
Division of Burns and Trauma, Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Richard M. Fairbanks Burn Center
Indianapolis, Indiana, United States, 46202
United States, New York
Long Island Plastic Surgical Group
Garden City, New York, United States, 11530
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Center for Innovation in Restorative Medicine
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Univ of Washington, Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Fibrocell Technologies, Inc.
Investigators
Principal Investigator: Daniel D Lozano, MD Lehigh Valley Health Network
  More Information

No publications provided

Responsible Party: Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01858753     History of Changes
Other Study ID Numbers: FI-B-003
Study First Received: May 10, 2013
Last Updated: January 21, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Fibrocell Technologies, Inc.:
burn scars
restrictive
contractures
autologous fibroblasts

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on September 02, 2015