Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

NCT01858753 | Terminated Phase 2 Results

• 1 other identifier: FI-B-003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 9

Brief Summary

This Phase II, double-blind, randomized, placebo-controlled pilot study is designed to determine whether injection of autologous fibroblasts can increase the mobility (decrease the restriction) of burn scars. The study will assess the effects of azficel-T (autologous fibroblasts) in subjects who have a unilateral burn scar that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either:

1. 1.An axillary scar causing 20-60% restriction of shoulder adduction
2. 2.An anterior elbow scar causing 20-60% restriction of elbow extension
3. 3.A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension

Conditions

Restrictive Burn Scars

Keywords

burn scars; restrictive; contractures; autologous fibroblasts

Outcome Measures

Primary Outcomes (5)

• Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint

  Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.

  Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)

• Percentage CFB of ROM of the Affected Joint

  Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.

  Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)

• Percentage CFB of ROM of the Affected Joint

  Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.

  Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)

• Percentage CFB of ROM of the Affected Joint

  Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.

  Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)

• Percentage CFB of ROM of the Affected Joint

  Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.

  Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)

Study Arms (2)

Autologous fibroblasts

EXPERIMENTAL

Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.

Biological: Autologous fibroblasts

Sterile saline

PLACEBO COMPARATOR

Sterile saline will be injected into the scar to be evaluated.

Biological: Autologous fibroblasts; Biological: placebo sterile saline

Interventions

Autologous fibroblasts BIOLOGICAL

Also known as: Azficel-T

Autologous fibroblasts; Sterile saline

placebo sterile saline BIOLOGICAL

Sterile saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years of age
• Subject has a unilateral burn scar of a jointed area (i.e., finger, elbow, shoulder) that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either:
• An axillary scar causing 20-60% restriction of shoulder abduction
• An anterior elbow scar causing 20-60% restriction of elbow extension
• A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension
• Subject's burn scar to be treated is \<100 sq cm in size
• Injury occurred ≤ 36 months prior to screening
• By the Investigator's assessment, physical therapy will not provide significant continuous improvement to the range of motion of the subject's joint
• 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 prior to the first treatment, and must agree to use a reliable means of birth control for the duration of the study
• Subject has healthy, non-scarred post auricular skin area suitable for biopsy
• Subject must have a normal complete blood count (CBC) and chemistry panel within 90 days prior to enrollment

You may not qualify if:

• Restrictive burn scars that are primarily classified as keloid scars
• Subjects for whom a post auricular biopsy cannot be collected for azficel-T production
• Sunburn or sun damage in the area that will be used for biopsy
• Plans to initiate any other 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, Ehlers Danlos syndrome, etc.
• Active systemic infection
• 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

Sponsors & Collaborators

• Castle Creek Biosciences, LLC.: lead

Study Sites (9)

Univ of California David Medical Center

Sacramento, California, 95817, United States

Location

Univ of California San Diego

San Diego, California, 92103, United States

Location

Division of Burns and Trauma, Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Richard M. Fairbanks Burn Center

Indianapolis, Indiana, 46202, United States

Location

Long Island Plastic Surgical Group

Garden City, New York, 11530, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Center for Innovation in Restorative Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Univ of Washington, Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Contracture

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Muscular Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects enrolled and completed; some data uninterpretable due to late data entry. With low enrollment (three subjects in mITT population and five subjects in safety population), a meaningful statistical analysis was not possible for this study.

Results Point of Contact

• Title: Head, Research and Development
• Organization: Castle Creek Biosciences

medinfo@castlecreekbio.com

13128471291

Study Officials

• Daniel D Lozano, MD

  Lehigh Valley Health Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 13, 2021
• Results First Posted: July 19, 2021

Record last verified: 2021-09

Locations

US (9)