Trial Outcomes & Findings for Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars (NCT NCT01858753)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

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

Results posted on

2021-10-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	Sterile Saline Sterile saline will be injected into the scar to be evaluated. Autologous fibroblasts placebo sterile saline
Overall Study STARTED	5	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autologous Fibroblasts n=3 Participants Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated. Autologous fibroblasts	Sterile Saline Sterile saline will be injected into the scar to be evaluated. Autologous fibroblasts placebo sterile saline	Total n=3 Participants Total of all reporting groups
Age, Continuous	56.0 years STANDARD_DEVIATION 13.00 • n=5 Participants	—	56.0 years STANDARD_DEVIATION 13.00 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	3 participants n=5 Participants
ROM of the Affected Joint	124.0 degrees STANDARD_DEVIATION 39.34 • n=5 Participants	—	124.0 degrees STANDARD_DEVIATION 39.34 • n=5 Participants

PRIMARY outcome

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

Population: Modified intent to treat population (mITT)

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.

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts n=3 Participants Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated. Autologous fibroblasts	Sterile Saline Sterile saline will be injected into the scar to be evaluated. Autologous fibroblasts placebo sterile saline
Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint	52.0 percent change Standard Deviation 23.40	—

PRIMARY outcome

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

Population: Modified intent to treat population

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.

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts n=3 Participants Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated. Autologous fibroblasts	Sterile Saline Sterile saline will be injected into the scar to be evaluated. Autologous fibroblasts placebo sterile saline
Percentage CFB of ROM of the Affected Joint	39.6 percent change Standard Deviation 10.88	—

PRIMARY outcome

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

Population: Modified intent to treat population

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.

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts n=3 Participants Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated. Autologous fibroblasts	Sterile Saline Sterile saline will be injected into the scar to be evaluated. Autologous fibroblasts placebo sterile saline
Percentage CFB of ROM of the Affected Joint	54.9 percent change Standard Deviation 25.86	—

PRIMARY outcome

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

Population: Modified intent to treat population

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.

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts n=3 Participants Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated. Autologous fibroblasts	Sterile Saline Sterile saline will be injected into the scar to be evaluated. Autologous fibroblasts placebo sterile saline
Percentage CFB of ROM of the Affected Joint	56.0 percent change Standard Deviation 29.33	—

PRIMARY outcome

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

Population: Modified intent to treat population

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.

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts n=3 Participants Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated. Autologous fibroblasts	Sterile Saline Sterile saline will be injected into the scar to be evaluated. Autologous fibroblasts placebo sterile saline
Percentage CFB of ROM of the Affected Joint	52.0 percent change Standard Deviation 23.40	—

Adverse Events

Autologous Fibroblasts

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sterile Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Autologous Fibroblasts n=5 participants at risk Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated. Autologous fibroblasts	Sterile Saline Sterile saline will be injected into the scar to be evaluated. Autologous fibroblasts placebo sterile saline
General disorders Injection site pain	20.0% 1/5 • Adverse events were collected from the time of the subject's biopsy through visit 9 (i.e., 360 days from their second treatment).	— 0/0 • Adverse events were collected from the time of the subject's biopsy through visit 9 (i.e., 360 days from their second treatment).
Nervous system disorders Syncope	20.0% 1/5 • Adverse events were collected from the time of the subject's biopsy through visit 9 (i.e., 360 days from their second treatment).	— 0/0 • Adverse events were collected from the time of the subject's biopsy through visit 9 (i.e., 360 days from their second treatment).

Additional Information

Head, Research and Development

Castle Creek Biosciences

Phone: 13128471291

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place