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

Primary Purpose

Restrictive Burn Scars of Joint Area

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Autologous Human Fibroblasts (Isolagen TherapyTM)
Placebo
Sponsored by
Castle Creek Biosciences, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restrictive Burn Scars of Joint Area

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Brigham and Women's Hospital
  • Nassau County Medical Center
  • University of Texas Medical Branch- Galveston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Arm

Control Arm

Arm Description

Active Treatment

Placebo treatment

Outcomes

Primary Outcome Measures

Change from baseline of all study assessments

Secondary Outcome Measures

Review of adverse Events, vital signs and physical examination

Full Information

First Posted
February 11, 2008
Last Updated
February 8, 2012
Sponsor
Castle Creek Biosciences, LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00620737
Brief Title
Pilot Safety and Efficacy Study of Isolagen Therapy in Treatment of Restrictive Burn Scars
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Company Decision
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Castle Creek Biosciences, LLC.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restrictive Burn Scars of Joint Area

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Arm
Arm Type
Experimental
Arm Description
Active Treatment
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Intervention Type
Biological
Intervention Name(s)
Autologous Human Fibroblasts (Isolagen TherapyTM)
Intervention Description
Collection of skin biopsy. Administration of 2 study injections Performance of various study assessments during clinic visits
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Collection of skin biopsy. Administration of 2 study injections Performance of various study assessments during clinic visits
Primary Outcome Measure Information:
Title
Change from baseline of all study assessments
Time Frame
Day 0, 14, 30, 60, 90 and 120
Secondary Outcome Measure Information:
Title
Review of adverse Events, vital signs and physical examination
Time Frame
Day 0, 14, 30, 60, 90 and 120

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Nassau County Medical Center
City
East Meadow
State/Province
New York
ZIP/Postal Code
11554
Country
United States
Facility Name
University of Texas Medical Branch- Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

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

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