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

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