Restrictive Burn Scars of Joint AreaPhase 2NCT00620737
Pilot Safety and Efficacy Study of Isolagen Therapy in Treatment of Restrictive Burn Scars
A Phase 2 study testing Autologous Human Fibroblasts (Isolagen TherapyTM) in people with Restrictive Burn Scars of Joint Area, run by Castle Creek Biosciences, LLC. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restrictive Burn Scars of Joint Area
- What is being tested?
- Autologous Human Fibroblasts (Isolagen TherapyTM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2008to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Nassau County Medical Center
East Meadow, New York, 11554
University of Texas Medical Branch- Galveston
Galveston, Texas, 77555
About this study
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
- Restrictive Burn Scars of Joint Area
- Being tested
- Autologous Human Fibroblasts (Isolagen TherapyTM), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Human Fibroblasts (Isolagen TherapyTM)Biological
- Collection of skin biopsy.
- Administration of 2 study injections
- Performance of various study assessments during clinic visits
PlaceboBiological
- Collection of skin biopsy.
- Administration of 2 study injections
- Performance of various study assessments during clinic visits
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Active Treatment Receives: Biological: Autologous Human Fibroblasts (Isolagen TherapyTM) |
| Control Arm | Placebo comparator | Placebo treatment Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of all study assessments
Measured: Day 0, 14, 30, 60, 90 and 120
Secondary outcomes (1)
Review of adverse Events, vital signs and physical examination
Measured: Day 0, 14, 30, 60, 90 and 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008 (estimated)
Why it stopped: Company Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restrictive Burn Scars of Joint AreaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castle Creek Biosciences, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620737
- Sponsor's protocol ID
- IT-B-001
- Status last verified
- Feb 2012
- First submitted
- 11 Feb 2008
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Safety and Efficacy Study of Isolagen Therapy in Treatment of Restrictive Burn Scars
- ClinicalTrials.gov ID
- NCT00620737
- Acronym / sponsor ID
- IT-B-001
- Conditions
- Restrictive Burn Scars of Joint Area
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Castle Creek Biosciences, LLC.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (estimated)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)Active Treatment |
| Control Arm | Placebo comparator | Biological: PlaceboPlacebo treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Active Arm |
| Placebo1. Collection of skin biopsy. 2. Administration of 2 study injections 3. Performance of various study assessments during clinic visits | Biological | Control Arm |
Primary outcome
Change from baseline of all study assessments
Time frame: Day 0, 14, 30, 60, 90 and 120
1 secondary outcome
Review of adverse Events, vital signs and physical examination
Time frame: Day 0, 14, 30, 60, 90 and 120
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Human Fibroblasts (Isolagen TherapyTM) in people with Restrictive Burn Scars of Joint Area, run by Castle Creek Biosciences, LLC. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of all study assessments (time frame: Day 0, 14, 30, 60, 90 and 120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2012.