Trial Outcomes & Findings for A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients (NCT NCT05944250)

Last Updated: 2025-09-15

Results Overview

The primary endpoint was comparison of the duration of wound closure of matrix-treated wounds vs control wounds measured as the number of wounds achieving greater than 90% wound closure within 4 months

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Baseline to month 4 of the randomized phase

Results posted on

2025-09-15

Participant Flow

Patients aged 6-65 years with a clinical and/or genetic diagnosis of recessive dystrophic epidermolysis bullosa were screened over the phone. If eligible a virtual meeting was organized, and patients were asked to review and sign the informed consent form after which the wounds were assessed to determine suitability. This target population was chosen due to their large painful wounds usually resistant to conventional treatment and would benefit most from Spincare matrix treatment.

On Day 0, the investigator conducted an in-person full body skin examination and collected wound measurements to verify eligibility. The participant's wounds were assessed for signs of infection, and target wound areas were identified. Wounds that were actively infected with pus were excluded before randomization and the application of the matrix.

Unit of analysis: wounds

Participant milestones

Participant milestones
Measure	Matrix-Treated Wounds (Randomized Period) A full body wound examination was performed by the investigator and target wound areas were marked. All eligible wound sites were randomized for matrix treatment versus standard of care wound dressings (at least 6 wounds, or 3 wound pairs). The matrix was applied to randomized treatment wounds, along with a non-adhesive bandage as a protective layer.	Standard of Care-Treated Wounds (Randomized Period) A full body wound examination was performed by the investigator and target wound areas were marked. All eligible wound sites were randomized for matrix treatment versus standard of care wound dressings (at least 6 wounds, or 3 wound pairs). The matrix was applied to randomized treatment wounds, along with a non-adhesive bandage as a protective layer.	Open-label - Matrix Treatment Participants from the randomized phase who were eligible and chose to participate, were enrolled at the 4 month long optional Open-Label Phase. Participant were allowed to treat previously randomized wounds (treated and control wounds) and new wounds, up to a max of 10 individuals wounds; there was no control or randomized wounds.
Randomized Period (4 Months) STARTED	6 21	6 21	0 0
Randomized Period (4 Months) COMPLETED	3 11	3 11	0 0
Randomized Period (4 Months) NOT COMPLETED	3 10	3 10	0 0
Open Label Period (4 Months) STARTED	0 0	0 0	1 5
Open Label Period (4 Months) COMPLETED	0 0	0 0	1 5
Open Label Period (4 Months) NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Matrix-Treated Wounds (Randomized Period) n=21 wounds Wounds that were randomized to receive matrix application.	Standard of Care-Treated Wounds (Randomized Period) n=21 wounds Wounds that were randomized to receive standard of care treatment.	Open Label - Matrix-Treated n=5 wounds Wounds that were selected to receive matrix application, no randomization, no controls.	Total n=47 wounds Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	21 years n=5 Participants	21 years n=7 Participants	33 years n=5 Participants	21 years n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	1 participants n=5 Participants	6 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to month 4 of the randomized phase

Population: Participants with month 4 data

Outcome measures

Outcome measures
Measure	Matrix-Treated Wounds (Randomized Period) n=11 Wounds Wounds that were randomized to receive matrix application.	Standard of Care-Treated Wounds (Randomized Period) n=11 Wounds Wounds that were randomized to receive standard of care treatment.	Matrix-Treated Wounds (Open Label Phase) A max. of 10 wounds per participant selected for matrix application. No controls, no randomization.
Number of Wounds With Greater Than 90% Wound Closure at 4 Months	0 Wounds	3 Wounds	—

SECONDARY outcome

Timeframe: 4-month randomized period followed by 4-month open-label period

Comparison of application site adverse events (burning, erythema, pain) between matrix-treated wounds vs control wounds after application. For this outcome, adverse events were collected per wound; events affecting the participant but not the wound are not included.

Outcome measures

Outcome measures
Measure	Matrix-Treated Wounds (Randomized Period) n=21 wounds Wounds that were randomized to receive matrix application.	Standard of Care-Treated Wounds (Randomized Period) n=21 wounds Wounds that were randomized to receive standard of care treatment.
Adverse Event Profile Characterization Any Adverse Event	11 wounds	10 wounds
Adverse Event Profile Characterization Pruritis, requiring medication to treat	2 wounds	0 wounds
Adverse Event Profile Characterization Pain of Skin, requiring medication to treat	3 wounds	0 wounds
Adverse Event Profile Characterization Bacterial Colonization	0 wounds	4 wounds
Adverse Event Profile Characterization Skin Infection (non-serious)	6 wounds	5 wounds

SECONDARY outcome

Timeframe: months 1, 2, 3, and 4 of the randomized phase

Population: Participants with available data at the respective time point

Pain was assessed using the Wong-Baker Faces scale (prior to matrix application). The scale consists of six faces that range from 0 (no pain at all, favorable outcome) to 10 (worst pain imaginable, worst outcome). Participants rated each wound using this scale, and scores were summed and averaged for each time point, resulting in an overall score range of 0 (no pain at all) to 10 (worst pain imaginable).

Outcome measures

Outcome measures
Measure	Matrix-Treated Wounds (Randomized Period) n=21 wounds Wounds that were randomized to receive matrix application.	Standard of Care-Treated Wounds (Randomized Period) n=21 wounds Wounds that were randomized to receive standard of care treatment.	Matrix-Treated Wounds (Open Label Phase) A max. of 10 wounds per participant selected for matrix application. No controls, no randomization.
Change From Baseline in Wound Pain Scale Score Assessment Baseline	3.143 score on a scale Standard Deviation 3.38	2.762 score on a scale Standard Deviation 3.71	—
Change From Baseline in Wound Pain Scale Score Assessment Change at Month 3	-1.45 score on a scale Standard Deviation 3.62	-0.73 score on a scale Standard Deviation 4.96	—
Change From Baseline in Wound Pain Scale Score Assessment Change at Month 4	-1.64 score on a scale Standard Deviation 2.71	-1.64 score on a scale Standard Deviation 3.8	—
Change From Baseline in Wound Pain Scale Score Assessment Change at Month 1	-1.43 score on a scale Standard Deviation 2.18	-1.52 score on a scale Standard Deviation 3.64	—
Change From Baseline in Wound Pain Scale Score Assessment Change at Month 2	0.43 score on a scale Standard Deviation 3.56	-1.71 score on a scale Standard Deviation 3.42	—

SECONDARY outcome

Timeframe: months 1, 2, 3, and 4 of the randomized phase

Population: Participants with available data at the respective time point

Wound itch scores were assessed using the Itch NRS (prior to matrix application). The Itch NRS is a numerical rating scale from 0 to 10. Participants rated each wound using this scale, and scores were summed and averaged for each time point, resulting in an overall score of 0 to 10 (higher scores correspond to more pain).

Outcome measures

Outcome measures
Measure	Matrix-Treated Wounds (Randomized Period) n=21 wounds Wounds that were randomized to receive matrix application.	Standard of Care-Treated Wounds (Randomized Period) n=21 wounds Wounds that were randomized to receive standard of care treatment.	Matrix-Treated Wounds (Open Label Phase) A max. of 10 wounds per participant selected for matrix application. No controls, no randomization.
Change in Wound Itch Scale Score Assessment Baseline	2.86 units on a scale Standard Deviation 2.55	2.10 units on a scale Standard Deviation 2.17	—
Change in Wound Itch Scale Score Assessment Change at Month 1	-1.19 units on a scale Standard Deviation 1.24	-0.71 units on a scale Standard Deviation 1.27	—
Change in Wound Itch Scale Score Assessment Change at Month 2	-0.85 units on a scale Standard Deviation 2.75	-0.43 units on a scale Standard Deviation 1.10	—
Change in Wound Itch Scale Score Assessment Change at Month 3	-1.36 units on a scale Standard Deviation 1.55	0.27 units on a scale Standard Deviation 1.65	—
Change in Wound Itch Scale Score Assessment Change at Month 4	-1.27 units on a scale Standard Deviation 1.59	-0.18 units on a scale Standard Deviation 1.73	—

SECONDARY outcome

Timeframe: months 1, 2, 3, and 4 of the randomized phase

Population: Participants with available data at the respective time point

Comparison of wounds that reach \>50% healing from baseline in matrix vs control (standard-of-care treated) wounds, per clinician assessment.

Outcome measures

Outcome measures
Measure	Matrix-Treated Wounds (Randomized Period) n=21 Wounds Wounds that were randomized to receive matrix application.	Standard of Care-Treated Wounds (Randomized Period) n=21 Wounds Wounds that were randomized to receive standard of care treatment.	Matrix-Treated Wounds (Open Label Phase) A max. of 10 wounds per participant selected for matrix application. No controls, no randomization.
Number of Wounds That Reach >50% Healing From Baseline Per Investigator Assessment Month 2	4 Wounds	5 Wounds	—
Number of Wounds That Reach >50% Healing From Baseline Per Investigator Assessment Month 3	4 Wounds	4 Wounds	—
Number of Wounds That Reach >50% Healing From Baseline Per Investigator Assessment Month 4	1 Wounds	5 Wounds	—
Number of Wounds That Reach >50% Healing From Baseline Per Investigator Assessment Month 1	8 Wounds	7 Wounds	—

SECONDARY outcome

Timeframe: months 1, 2, 3, and 4 of the randomized phase

Population: Number of wounds that reach \>70% healing from baseline in matrix-treated vs control wounds

Comparison of wounds that reach \>70% healing from baseline in matrix-treated vs control wounds, per clinician assessment.

Outcome measures

Outcome measures
Measure	Matrix-Treated Wounds (Randomized Period) n=21 Wounds Wounds that were randomized to receive matrix application.	Standard of Care-Treated Wounds (Randomized Period) n=21 Wounds Wounds that were randomized to receive standard of care treatment.	Matrix-Treated Wounds (Open Label Phase) A max. of 10 wounds per participant selected for matrix application. No controls, no randomization.
Number of Wounds That Reach >70% Healing From Baseline Per Investigator Assessment Month 1	4 Wounds	5 Wounds	—
Number of Wounds That Reach >70% Healing From Baseline Per Investigator Assessment Month 2	3 Wounds	4 Wounds	—
Number of Wounds That Reach >70% Healing From Baseline Per Investigator Assessment Month 3	1 Wounds	3 Wounds	—
Number of Wounds That Reach >70% Healing From Baseline Per Investigator Assessment Month 4	0 Wounds	4 Wounds	—

Adverse Events

Matrix-Treated Wounds (Randomized Period)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard of Care-Treated Wounds (Randomized Period)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Matrix-Treated Wounds (Open-Label Period)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Systemic Adverse Events (Randomized Period)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Systemic Adverse Events (Open-Label Period)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Matrix-Treated Wounds (Randomized Period) n=6 participants at risk Adverse events localized to the area of the body with wounds that were randomized to receive matrix application.	Standard of Care-Treated Wounds (Randomized Period) n=6 participants at risk Adverse events localized to the area of the body with wounds that were randomized to receive standard of care treatment.	Matrix-Treated Wounds (Open-Label Period) n=1 participants at risk Adverse events localized to the area of the body with wounds that were selected to receive matrix application, no randomization, no controls.	Systemic Adverse Events (Randomized Period) n=6 participants at risk All Adverse Events, including those that affected participants as a whole (systemic events)	Systemic Adverse Events (Open-Label Period) n=1 participants at risk All Adverse Events, including those that affected participants as a whole (systemic events)
Skin and subcutaneous tissue disorders Skin infection	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Reproductive system and breast disorders Mammary Gland Carcinoma	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period

Other adverse events

Other adverse events
Measure	Matrix-Treated Wounds (Randomized Period) n=6 participants at risk Adverse events localized to the area of the body with wounds that were randomized to receive matrix application.	Standard of Care-Treated Wounds (Randomized Period) n=6 participants at risk Adverse events localized to the area of the body with wounds that were randomized to receive standard of care treatment.	Matrix-Treated Wounds (Open-Label Period) n=1 participants at risk Adverse events localized to the area of the body with wounds that were selected to receive matrix application, no randomization, no controls.	Systemic Adverse Events (Randomized Period) n=6 participants at risk All Adverse Events, including those that affected participants as a whole (systemic events)	Systemic Adverse Events (Open-Label Period) n=1 participants at risk All Adverse Events, including those that affected participants as a whole (systemic events)
General disorders Fever	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Infections and infestations Flu-like symptoms	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	50.0% 3/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Infections and infestations Lymph node infection	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Nervous system disorders Headache, migraine	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	0.00% 0/6 • 4-month randomized period followed by 4-month open-label period	100.0% 1/1 • 4-month randomized period followed by 4-month open-label period
Skin and subcutaneous tissue disorders Pruritis, requiring treatment	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Skin and subcutaneous tissue disorders Pain of skin, requiring treatment	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Infections and infestations Bacterial colonization	0.00% 0/6 • 4-month randomized period followed by 4-month open-label period	33.3% 2/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period	33.3% 2/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Infections and infestations Skin Infection	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	33.3% 2/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period	50.0% 3/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Gastrointestinal disorders Toothache, chipped tooth	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Immune system disorders Allergic reaction, seasonal allergies	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Infections and infestations Upper respiratory tract infection	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	33.3% 2/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Psychiatric disorders Insomnia	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Reproductive system and breast disorders Premature menopause	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Reproductive system and breast disorders Vaginal discharge	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Skin and subcutaneous tissue disorders Bullous dermatitis	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Eye disorders Vision decreased, hyperopia	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period
Gastrointestinal disorders Dental caries	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	— 0/0 • 4-month randomized period followed by 4-month open-label period	16.7% 1/6 • 4-month randomized period followed by 4-month open-label period	0.00% 0/1 • 4-month randomized period followed by 4-month open-label period

Additional Information

Dr. Yuri Ikeda

Stanford University

Phone: 650-647-3485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place