Pilot Safety and Efficacy Study of Isolagen Therapy in Treatment of Restrictive Burn Scars

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM and placebo when administered to stable restrictive burn scars of an affected joint area.

Conditions
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Restrictive Burn Scars of Joint Area

Intervention / Treatment
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* Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years of age Subject has stable restrictive burn scar of a jointed area that restricts range of motion (ROM) of the affected joint by greater than or equal to 20% and that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) 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 Females of childbearing potential must have a negative urine pregnancy test at the screening visit and must agree to use a reliable means of birth control for the duration of the study Male subjects must agree to use a reliable means of birth control for the duration of the study Subject has healthy, non-scarred post auricular, abdomen, back of neck at hairline, lower abdomen, upper arm, side of upper leg, or axillary region (on the lateral thorax) skin area suitable for biopsy Subject has normal CBC, thyroid function, renal function, liver function, blood glucose and SMA 18 at Screening Exclusion Criteria: The restrictive burn scar to be treated is primarily classified as a keloid scar Surgical release of scar to be treated within the last 12 months Subjects for whom a skin biopsy cannot be collected Plans to initiate any 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, or Ehlers Danlos syndrome Active systemic infection as shown by any one of the following: symptoms, fever and/or an elevated white count (subjects who present with an active systemic infection may be enrolled and biopsied after the infection has resolved) Requires chronic antibiotic or steroidal therapy Any conditions that are considered by the Investigator to be contraindications to biopsy or injection Pregnant or lactating women or women trying to become pregnant during the study 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 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 Subjects with a known allergy to gentamycin or amphotericin B, or sensitivity to materials of bovine origin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Arm<br>Active Treatment | Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)<br>* Collection of skin biopsy. Administration of 2 study injections Performance of various study assessments during clinic visits<br>|
| Placebo Comparator: Control Arm<br>Placebo treatment | Biological: Placebo<br>* Collection of skin biopsy. Administration of 2 study injections Performance of various study assessments during clinic visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of all study assessments |  | Day 0, 14, 30, 60, 90 and 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Review of adverse Events, vital signs and physical examination |  | Day 0, 14, 30, 60, 90 and 120 |