A Phase II, Double-Blind, Randomized, Placebo-Controlled Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Restrictive Burn Scars
- Sponsor
- Castle Creek Biosciences, LLC.
- Enrollment
- 5
- Locations
- 9
- Primary Endpoint
- Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
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:
- An axillary scar causing 20-60% restriction of shoulder adduction
- An anterior elbow scar causing 20-60% restriction of elbow extension
- 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is at least 18 years of age
- •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:
- •An axillary scar causing 20-60% restriction of shoulder abduction
- •An anterior elbow scar causing 20-60% restriction of elbow extension
- •A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension
- •Subject's burn scar to be treated is \<100 sq cm in size
- •Injury occurred ≤ 36 months prior to screening
- •By the Investigator's assessment, physical therapy will not provide significant continuous improvement to the range of motion of the subject's joint
- •Subject agrees to maintain any current physical therapy regimen for the duration of the study
- •Subject must be able to provide written informed consent and comply with the study requirements
Exclusion Criteria
- •Restrictive burn scars that are primarily classified as keloid scars
- •Subjects for whom a post auricular biopsy cannot be collected for azficel-T production
- •Sunburn or sun damage in the area that will be used for biopsy
- •Plans to initiate any other new scar therapy during the study period
- •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
- •History of active autoimmune disease or organ transplantation
- •Diagnosis of cancer, including basal cell carcinoma, unless successfully treated or in remission for a minimum of 6 months
- •Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, epidermolysis bullosa, ataxia-telangiectasia, Ehlers Danlos syndrome, etc.
- •Active systemic infection
- •Requires chronic antibiotic or steroidal therapy
Outcomes
Primary Outcomes
Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
Time Frame: Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
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.
Percentage CFB of ROM of the Affected Joint
Time Frame: Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)
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.