Trial Outcomes & Findings for A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures (NCT NCT01564407)

Results Overview

The evaluation of safety of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through assessment of adverse events. The primary objective of the safety (no injection) cohort is to evaluate initial safety of multiple doses through assessment of adverse events. The primary objective of remaining cohorts is to evaluate the ongoing safety of ICX-RHY-013 in post-burn hypertrophic scars that are not planned for excision through assessment of adverse events.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Days 0, 7, 14, 28, 56, 84

Results posted on

2017-07-11

Participant Flow

Multiple approaches for subject recruitment were implemented.The Center for Innovation in Restorative (CIRM) hired a marketing specialist who investigated the use of non-traditional mechanisms within and outside the existing infrastructure including but not limited to social media outlet,use of internal/external physician networks,TV advertising

All of the subjects who were enrolled (signed consent) were randomized to 1 of 4 cohorts.

Participant milestones

Participant milestones
Measure	No Injection Safety cohort. 4 subjects received empty control. No injection	Vehicle Only Vehicle only (0.5 ml of solution)	Single Admin Drug Day 0 Single administration of study drug on day 0	Single Admin Drug Day 28 Single administration on Day 28
Overall Study STARTED	4	5	4	2
Overall Study COMPLETED	4	3	4	1
Overall Study NOT COMPLETED	0	2	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Vehicle Only Vehicle only (0.5 ml of solution)	Single Admin Drug Day 28 Single administration on Day 28
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study funding lost, study ended	0	1

Baseline Characteristics

A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Injection n=4 Participants Empty safety control, no injection	Vehicle Only n=5 Participants Vehicle only (0.5 ml of HypoThermosol solution)	Single Admin Day 0 n=4 Participants 5 million cells / cm² , single administration at Day 0	Single Admin Day 28 n=2 Participants 5 million cells/ cm² , single administration at day 28	Admin Day 0 and 28 5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28	Total n=15 Participants Total of all reporting groups
Age, Customized <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	—	0 participants n=10 Participants
Age, Customized Between 18 and 65 years	4 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	2 participants n=4 Participants	—	15 participants n=10 Participants
Age, Customized >=65 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	—	0 participants n=10 Participants
Age, Continuous	32.25 years STANDARD_DEVIATION 12.3 • n=5 Participants	41.25 years STANDARD_DEVIATION 17.0 • n=7 Participants	45.75 years STANDARD_DEVIATION 14.9 • n=5 Participants	62 years STANDARD_DEVIATION 0 • n=4 Participants	—	45.3 years STANDARD_DEVIATION 12.4 • n=10 Participants
Sex/Gender, Customized Female	4 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	—	5 participants n=10 Participants
Sex/Gender, Customized Male	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	2 participants n=4 Participants	—	10 participants n=10 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	2 participants n=4 Participants	—	15 participants n=10 Participants

PRIMARY outcome

Timeframe: Days 0, 7, 14, 28, 56, 84

The evaluation of safety of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through assessment of adverse events. The primary objective of the safety (no injection) cohort is to evaluate initial safety of multiple doses through assessment of adverse events. The primary objective of remaining cohorts is to evaluate the ongoing safety of ICX-RHY-013 in post-burn hypertrophic scars that are not planned for excision through assessment of adverse events.

Outcome measures

Outcome measures
Measure	no Injection n=4 Participants Empty control no injection	Vehicle Only n=3 Participants Vehicle only (0.5 ml of solution)	Single Admin Drug Day 0 n=4 Participants Single administration of study drug on day 0	Single Admin Drug Day 28 n=1 Participants Single administration of study drug on day 28	Vehicle Only Vehicle only (0.5 ml of HypoThermosol solution)
Number of Participants With Adverse Events	4 participants	3 participants	4 participants	1 participants	—

PRIMARY outcome

Timeframe: 12 weeks

The evaluation of tolerability of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through regular assessment of adverse events.

Outcome measures

Outcome measures
Measure	no Injection n=4 Participants Empty control no injection	Vehicle Only n=3 Participants Vehicle only (0.5 ml of solution)	Single Admin Drug Day 0 n=4 Participants Single administration of study drug on day 0	Single Admin Drug Day 28 n=1 Participants Single administration of study drug on day 28	Vehicle Only Vehicle only (0.5 ml of HypoThermosol solution)
Number of Participants With Serious Adverse Events Reported	0 participants	0 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Endpoints assessed at Day 84.

The secondary objectives of this study are to evaluate improvement in symptoms of hypertrophic scars.

Outcome measures

Outcome measures
Measure	no Injection n=4 Participants Empty control no injection	Vehicle Only n=3 Participants Vehicle only (0.5 ml of solution)	Single Admin Drug Day 0 n=4 Participants Single administration of study drug on day 0	Single Admin Drug Day 28 n=1 Participants Single administration of study drug on day 28	Vehicle Only Vehicle only (0.5 ml of HypoThermosol solution)
Percentage of Subjects Worse Hypertrophic Scars	0 percentage of paricipants	0 percentage of paricipants	0 percentage of paricipants	0 percentage of paricipants	—

SECONDARY outcome

Timeframe: 12 weeks

Vancouver scar scale will be evaluated for each cohort. The Vancouver scar scale is the most frequently cited assessment of scar severity used in clinical studies. Pigmentation, vascularity, pliability, and scar height are graded producing a composite score. A score of 0 represents normal skin with higher grades representing greater deformity with a maximum possible rating of 14.

Outcome measures

Outcome measures
Measure	no Injection n=4 Participants Empty control no injection	Vehicle Only n=2 Participants Vehicle only (0.5 ml of solution)	Single Admin Drug Day 0 Single administration of study drug on day 0	Single Admin Drug Day 28 n=4 Participants Single administration of study drug on day 28	Vehicle Only n=5 Participants Vehicle only (0.5 ml of HypoThermosol solution)
Vancouver Scar Scale	8 scores on a scale Standard Deviation 2	10 scores on a scale Standard Deviation 2.2	—	10 scores on a scale Standard Deviation 3	8 scores on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 12 weeks

POSAS aims to measure scar quality, it is a comprehensive scale designed for the evaluation of all types of scars by professionals and patients. It contains two scales with six items, scored numerically from 0-10, where 0 is normal skin and 10 is the worst scar imaginable. the total scoring range is from 0-120.

Outcome measures

Outcome measures
Measure	no Injection n=4 Participants Empty control no injection	Vehicle Only n=2 Participants Vehicle only (0.5 ml of solution)	Single Admin Drug Day 0 Single administration of study drug on day 0	Single Admin Drug Day 28 n=4 Participants Single administration of study drug on day 28	Vehicle Only n=5 Participants Vehicle only (0.5 ml of HypoThermosol solution)
Patient and Observer Scar Assessment Scale (POSAS)	24.67 scores on a scale Standard Deviation 1.53	34.25 scores on a scale Standard Deviation 11.32	—	42.13 scores on a scale Standard Deviation 8.16	41.57 scores on a scale Standard Deviation 4.32

SECONDARY outcome

Timeframe: 12 weeks

The six subjects suffering from upper extremity and cervical scar contractures were evaluated with the Disability of Arm, Shoulder and Hand (DASH) questionnaire. The DASH questionnaire evaluates symptoms and functional status. A lowest score of 0 indicates normal skin and highest score of 100 represents the greatest possible morbidity.

Outcome measures

Outcome measures
Measure	no Injection n=4 Participants Empty control no injection	Vehicle Only n=2 Participants Vehicle only (0.5 ml of solution)	Single Admin Drug Day 0 Single administration of study drug on day 0	Single Admin Drug Day 28 n=4 Participants Single administration of study drug on day 28	Vehicle Only n=5 Participants Vehicle only (0.5 ml of HypoThermosol solution)
Disability Index-Disability of Arm, Shoulder and Hand	6.9 scores on a scale Standard Deviation 6	11.6 scores on a scale Standard Deviation 14.1	—	75.5 scores on a scale Standard Deviation 3.8	69.2 scores on a scale Standard Deviation 12.7

SECONDARY outcome

Timeframe: 12 weeks

SWAP is a psychological test for personality diagnosis. there are 9 questions evaluated by a score of 7 (most descriptive to the patient) to 0 (not descriptive or irrelevant) for a total scoring range of 0-63.