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

A Phase II, Double-Blind, Randomized, Placebo-Controlled Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01858753

Enrollment

Registered

2013-05-21

Start date

2013-05-31

Completion date

2016-07-31

Last updated

2021-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restrictive Burn Scars

Keywords

burn scars, restrictive, contractures, autologous fibroblasts

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. An axillary scar causing 20-60% restriction of shoulder adduction 2. An anterior elbow scar causing 20-60% restriction of elbow extension 3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension Subjects will each receive 2 injections of azficel-T or placebo administered 14 days (± 7 days) apart (depending on cell availability) and will be followed for efficacy (including range of motion measurements, scar pain and ability to perform activities) to Visit 7 and for safety to Visit 9 at 1 year.

Interventions

BIOLOGICALAutologous fibroblasts

BIOLOGICALplacebo sterile saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subject is at least 18 years of age 2. 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: 1. An axillary scar causing 20-60% restriction of shoulder abduction 2. An anterior elbow scar causing 20-60% restriction of elbow extension 3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension 3. Subject's burn scar to be treated is \<100 sq cm in size 4. Injury occurred ≤ 36 months prior to screening 5. By the Investigator's assessment, physical therapy will not provide significant continuous improvement to the range of motion of the subject's joint 6. Subject agrees to maintain any current physical therapy regimen for the duration of the study 7. Subject must be able to provide written informed consent and comply with the study requirements 8. 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 9. Subject has healthy, non-scarred post auricular skin area suitable for biopsy 10. Subject must have a normal complete blood count (CBC) and chemistry panel within 90 days prior to enrollment

Exclusion criteria

1. Restrictive burn scars that are primarily classified as keloid scars 2. Subjects for whom a post auricular biopsy cannot be collected for azficel-T production 3. Sunburn or sun damage in the area that will be used for biopsy 4. Plans to initiate any other new scar therapy during the study period 5. 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 6. History of active autoimmune disease or organ transplantation 7. Diagnosis of cancer, including basal cell carcinoma, unless successfully treated or in remission for a minimum of 6 months 8. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, epidermolysis bullosa, ataxia-telangiectasia, Ehlers Danlos syndrome, etc. 9. Active systemic infection 10. Requires chronic antibiotic or steroidal therapy 11. Any conditions that are considered by the Investigator to be contraindications to biopsy or injection 12. Pregnant or lactating women, or women trying to become pregnant during the study 13. 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 14. 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

Design outcomes

Primary

Measure	Time frame	Description
Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint	Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)	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.
Percentage CFB of ROM of the Affected Joint	Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)	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.

Countries

United States

Participant flow

Pre-assignment details

Subjects were screened to determine eligibility for the study prior to enrollment. Once the subjects were enrolled, the biopsy was performed within 14 days after screening. Subjects were then randomized sequentially as their cells were harvested and found to be acceptable.

Participants by arm

Arm	Count
Autologous Fibroblasts Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated. Autologous fibroblasts	3
Sterile Saline Sterile saline will be injected into the scar to be evaluated. Autologous fibroblasts placebo sterile saline	0
Total	3

Baseline characteristics

Characteristic	Total	Autologous Fibroblasts
Age, Continuous	56.0 years STANDARD_DEVIATION 13	56.0 years STANDARD_DEVIATION 13
Region of Enrollment United States	3 participants	3 participants
ROM of the Affected Joint	124.0 degrees STANDARD_DEVIATION 39.34	124.0 degrees STANDARD_DEVIATION 39.34
Sex: Female, Male Female	0 Participants	0 Participants
Sex: Female, Male Male	3 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 5	0 / 0
other Total, other adverse events	2 / 5	0 / 0
serious Total, serious adverse events	0 / 5	0 / 0