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

A Phase II, Double-Blind, Randomized, Placebo-Controlled Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

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.

Study Overview

• Status: Terminated
• Conditions: Restrictive Burn Scars
• Intervention / Treatment: Biological: Autologous fibroblasts; Biological: placebo sterile saline

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Univ of California David Medical Center
    • San Diego, California, United States, 92103
      • Univ of California San Diego
  • Florida
    • Miami, Florida, United States, 33136
      • Division of Burns and Trauma, Jackson Memorial Hospital
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Richard M. Fairbanks Burn Center
  • New York
    • Garden City, New York, United States, 11530
      • Long Island Plastic Surgical Group
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
    • Pittsburgh, Pennsylvania, United States, 15213
      • Center for Innovation in Restorative Medicine
  • Washington
    • Seattle, Washington, United States, 98104
      • Univ of Washington, Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Azficel-T
Placebo Comparator: Sterile saline; Sterile saline will be injected into the scar to be evaluated.	Biological: Autologous fibroblasts; Other Names: Azficel-T; Biological: placebo sterile saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint	Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.	Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
Percentage CFB of ROM of the Affected Joint	Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.	Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)
Percentage CFB of ROM of the Affected Joint	Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.	Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)
Percentage CFB of ROM of the Affected Joint	Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.	Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)
Percentage CFB of ROM of the Affected Joint	Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.	Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)

Collaborators and Investigators

• Sponsor: Castle Creek Biosciences, LLC.
• Investigators: Principal Investigator: Daniel D Lozano, MD, Lehigh Valley Health Network

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: May 10, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: restrictive; contractures; burn scars; autologous fibroblasts
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Fibrosis; Burns; Cicatrix
• Other Study ID Numbers: FI-B-003