Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
Condition: Restrictive Burn Scars
MeSH terms: Cicatrix; Burns
Intervention: Autologous fibroblasts; placebo sterile saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: burn scars; restrictive; contractures; autologous fibroblasts

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:

        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.
    

Eligibility 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