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

Castle Creek Biosciences

Status and phase

Withdrawn

Phase 2

Conditions

Restrictive Burn Scars of Joint Area

Treatments

Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00620737

IT-B-001

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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