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

This study has been withdrawn prior to enrollment.
(Company Decision)
Sponsor:
Information provided by (Responsible Party):
Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00620737
First received: February 11, 2008
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Restrictive Burn Scars of Joint Area
Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Fibrocell Technologies, Inc.:

Primary Outcome Measures:
  • Change from baseline of all study assessments [ Time Frame: Day 0, 14, 30, 60, 90 and 120 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Review of adverse Events, vital signs and physical examination [ Time Frame: Day 0, 14, 30, 60, 90 and 120 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Arm
Active Treatment
Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)
  1. Collection of skin biopsy.
  2. Administration of 2 study injections
  3. Performance of various study assessments during clinic visits
Placebo Comparator: Control Arm
Placebo treatment
Biological: Placebo
  1. Collection of skin biopsy.
  2. Administration of 2 study injections
  3. Performance of various study assessments during clinic visits

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620737

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Nassau County Medical Center
East Meadow, New York, United States, 11554
United States, Texas
University of Texas Medical Branch- Galveston
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Fibrocell Technologies, Inc.
  More Information

No publications provided

Responsible Party: Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00620737     History of Changes
Other Study ID Numbers: IT-B-001
Study First Received: February 11, 2008
Last Updated: February 8, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014