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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Fibrocell Technologies, Inc.
Sponsor:
Information provided by (Responsible Party):
Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01858753
First received: May 10, 2013
Last updated: June 9, 2014
Last verified: June 2014
  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 2014
Estimated Primary Completion Date: October 2014 (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 Recruiting
Sacramento, California, United States, 95817
Contact: Mary Beth Lawless, MS, RN    916-453-2133    Marybeth.lawless@ucdmc.ucdavis.edu   
Contact: Lynda Painting    916-453-5085    lpainting@shrinenet.org   
Principal Investigator: David Greenhalgh, MD         
Univ of California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Lori Murphy    858-576-1700 ext 5210    lmurphy@rchsd.org   
Principal Investigator: Andrew Krakowski, MD         
United States, Florida
Division of Burns and Trauma, Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Ron Manning, RN    305-355-4975    rmanning@med.miami.edu   
Principal Investigator: Nicholas Namias, MD         
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Marcia Halerz       mhalerz@luc.edu   
Contact: Peggie Conrad    708-327-2459    pconrad@luc.edu   
Principal Investigator: Robert Gamelli, MD         
United States, Indiana
Richard M. Fairbanks Burn Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: David Roggy    317-880-6830    davidroggy@gmail.com   
Principal Investigator: Rajiv Sood, MD         
United States, New York
Long Island Plastic Surgical Group Recruiting
Garden City, New York, United States, 11530
Contact: Tammy Manchester, RN    516-629-3838    tmanchester@lipsg.com   
Contact: Donna Greenstein    516-296-7460    dgreenstein@lipsg.com   
Principal Investigator: Louis Riina, MD         
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Traci Eichelberger, RN    610-402-1286    traci_l.eichelberger@lvhn.org   
Principal Investigator: Daniel Lozano, MD         
Center for Innovation in Restorative Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Mara Yerk    412-864-2588    yerkma@upmc.edu   
Principal Investigator: Peter Rubin, MD         
United States, Washington
Univ of Washington, Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Shari E Honari    206-744-3587    shonari@uw.edu   
Principal Investigator: Nicole Gibran, MD         
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: June 9, 2014
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
Cicatrix
Wounds and Injuries
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on September 15, 2014