## Protocol Section
### Identification Module
**NCT ID:** NCT01263379

**Brief Title:** Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa

**Official Title:** A Phase 1/2A Single Center Trial of Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Using the Drug LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

#### Organization Study ID Info
**ID:** SU-10202010-7130
#### Organization
**Class:** INDUSTRY
**Full Name:** Abeona Therapeutics, Inc
#### Secondary ID Infos
**ID:** R01AR055914
**Link:** https://reporter.nih.gov/quickSearch/R01AR055914
**Type:** NIH
**Domain:** NIH Recombinant DNA Advisory Committee
**ID:** RAC Protocol # 0701-827
**Type:** OTHER
**Domain:** Stanford Institutional Review Board
**ID:** eProtocol 14563
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2022-03-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-22

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-03-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-07-10

**Type:** ACTUAL

**Results First Submit Date:** 2023-04-18

**Results First Submit QC Date:** 2023-06-19

#### Start Date
**Date:** 2010-10-05

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2010-12-20
**Type:** ESTIMATED
**Study First Submit Date:** 2010-12-15
**Study First Submit QC Date:** 2010-12-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

**Class:** OTHER

**Name:** Stanford University

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Abeona Therapeutics, Inc

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This trial will create a skin graft, which the investigators call "LEAES," using the patient's own skin cells that have been genetically engineered in the lab to express a missing protein called type VII collagen. The corrected cells will be transplanted back to the patient.

**Detailed Description:** The research project involves gene transfer into keratinocytes, which are the majority of the cells in the outer layer of skin. In this gene transfer trial we plan to biopsy some skin tissue, grow the cells in a skin cell culture (sterile dishes with special fluid that allows cells to grow and multiply) and then infect the cells with a virus that we have genetically engineered to insert the correct type VII collagen gene. The cells should then make type VII collagen.

The process of inserting the correct type VII collagen gene into cells is called "gene transfer." The virus used is called a "retrovirus." The virus is made so that it only delivers the type VII collagen gene and it should not spread to other parts of the body. During the study we will check for growth of the virus.

After cells have received gene transfer, we will grow the cells in culture into a sheet of cells that look like a plastic film. We plan to graft the sheet to wounds. Grafting means we will take cells from the culture and stitch them to the patient's skin.

### Conditions Module

**Conditions:**

- Epidermolysis Bullosa Dystrophica

- Epidermolysis Bullosa

**Keywords:**

- gene transfer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

**Intervention Names:**

- Biological: LZRSE-Col7A1 Engineered Autologous Epidermal Sheets

**Label:** LEAES treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- LEAES treatment

**Description:** This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein.

**Name:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets

**Other Names:**

- LEAES

**Type:** BIOLOGICAL

### Outcomes Module

#### Other Outcomes

**Description:** Skin biopsies were obtained to observe physical development of the anchoring fibrils using electron microscopy

**Measure:** Number of Participants With Presence of Anchoring Fibrils (AF)

**Time Frame:** 3 months, 6 months, 12 months and 24 months post grafting

#### Primary Outcomes

**Description:** The graft site was clinically evaluated by the investigator with a global score of: 1) 100% to 75% healed, 2) 74% to 50% healed, 3) 49% or less healed with 100% meaning completely healed.

**Measure:** Number of Wounds by Healing Category Per Investigator Visual Assessment

**Time Frame:** 3, 6, 12 and 24 months post grafting

**Description:** Percentage of wound area will be obtained using the Canfield system. Changes in dimensions between visits as well as changes in dimensions from baseline will be recorded. Dimensions of untreated wounded skin will be used for comparison

**Measure:** Percentage Surface Area of Wound Healing

**Time Frame:** 3, 6 and 12 months post grafting

#### Secondary Outcomes

**Description:** Skin biopsies were obtained to evaluate expression of type VII collagen, NC2 epitope, using immuno-electron microscopy and immuno-fluorescent light microscopy.

**Measure:** Number Participants Positive for NC2 Epitope as a Measure of Duration of Type VII Collagen Production

**Time Frame:** 3 months, 6 months, 12 months, 24 months post-grafting

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Clinical diagnosis of recessive dystrophic epidermolysis bullosa (RDEB)
2. 13 years old or older and willing and able to give assent/consent
3. Confirmation of RDEB diagnosis by immunofluorescence (IF) and electron microscopy (EM)
4. NC1\[+\] and mAb LH24 antibody staining negative
5. RDEB type VII collagen mutations in subject and carrier parents confirmed
6. At least 100 to 200 cm2 areas of open erosions on the trunk and/or extremities suitable for skin grafting
7. Able to undergo adequate anesthesia to allow grafting procedures to take place.

Exclusion Criteria:

1. Medical instability limiting ability to travel to Stanford University Medical Center
2. The presence of medical illness expected to complicate participation and/or compromise the safety of this technique, such as active infection with HIV, hepatitis B or hepatitis C, as determined by hepatitis B surface antigen screening, detection of hepatitis C antibodies, or positive result of hepatitis C polymerase chain reaction (PCR) analysis.
3. Antibodies to type VII collagen associated antigens
4. Active infection in the area that will undergo grafting
5. Evidence of systemic infection
6. Current evidence or a history of squamous cell carcinoma in the area that will undergo grafting
7. Active drug or alcohol addiction
8. Hypersensitivity to vancomycin or amikacin
9. Receipt of chemical or biological study product for the specific treatment of RDEB in the past six months
10. Positive pregnancy test or breast-feeding
11. Clinically significant abnormalities (Grade 2 or higher on the National Cancer Institute \[NCI\] toxicity scale) on laboratory tests performed prior to grafting, except for the following specific exclusionary laboratory threshold results, subject to approval or exemption by the EB physician:

    * Albumin \< 2.5 g/dL
    * Leukocytes \> 20K/uL
    * Hemoglobin \< 7.5 g/dL. Low hemoglobin will be treated at the discretion of the investigators and the EB physician.
    * Additional exceptions may be made at the discretion of the investigators and the EB physician.
12. Clinically significant abnormalities (Grade 2 or higher on the NCI toxicity scale) identified through medical history and physical examination on Day 0, with the following exceptions:

    * Anorexia, can enroll up to Grade 4 (inclusive)
    * Constipation, can enroll up to Grade 2 (inclusive)
    * Dysphagia, can enroll up to Grade 4 (inclusive)
    * Keratitis, can enroll up to Grade 4 (inclusive)
    * Bone pain, can enroll up to Grade 2 (inclusive)
    * Additional exceptions may be made at the discretion of the investigators and the EB physician.

**Minimum Age:** 13 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Redwood City

**Country:** United States

**Facility:** Stanford University, School of Medicine, Dept of Dermatology

**State:** California

**Zip:** 94063

#### Overall Officials

**Official 1:**

**Affiliation:** Stanford University

**Name:** Jean Tang, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Results will be submitted to scientific journals for publication and presented at scientific meetings.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** Study protocol is attached to this submission and will be available per ClinicalTrials.gov timeline.

### References Module

#### References

**Citation:** So JY, Nazaroff J, Iwummadu CV, Harris N, Gorell ES, Fulchand S, Bailey I, McCarthy D, Siprashvili Z, Marinkovich MP, Tang JY, Chiou AS. Long-term safety and efficacy of gene-corrected autologous keratinocyte grafts for recessive dystrophic epidermolysis bullosa. Orphanet J Rare Dis. 2022 Oct 17;17(1):377. doi: 10.1186/s13023-022-02546-9.

**PMID:** 36253825

**Citation:** Eichstadt S, Barriga M, Ponakala A, Teng C, Nguyen NT, Siprashvili Z, Nazaroff J, Gorell ES, Chiou AS, Taylor L, Khuu P, Keene DR, Rieger K, Khosla RK, Furukawa LK, Lorenz HP, Marinkovich MP, Tang JY. Phase 1/2a clinical trial of gene-corrected autologous cell therapy for recessive dystrophic epidermolysis bullosa. JCI Insight. 2019 Oct 3;4(19):e130554. doi: 10.1172/jci.insight.130554.

**PMID:** 31578311

**Citation:** Siprashvili Z, Nguyen NT, Gorell ES, Loutit K, Khuu P, Furukawa LK, Lorenz HP, Leung TH, Keene DR, Rieger KE, Khavari P, Lane AT, Tang JY, Marinkovich MP. Safety and Wound Outcomes Following Genetically Corrected Autologous Epidermal Grafts in Patients With Recessive Dystrophic Epidermolysis Bullosa. JAMA. 2016 Nov 1;316(17):1808-1817. doi: 10.1001/jama.2016.15588.

**PMID:** 27802546

#### See Also Links

**Label:** Stanford Dermatology Website: EB Research Update

**URL:** http://dermatology.stanford.edu/gsdc/eb_clinic/trials/index.html

**Label:** Safety and Wound Outcomes Following Genetically Corrected Autologous Epidermal Grafts in Patients With Recessive Dystrophic Epidermolysis Bullosa.

**URL:** https://www.ncbi.nlm.nih.gov/pubmed/27802546

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-05-13

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 628515

- Type Abbrev: Prot_SAP

- Upload Date: 2023-06-19T15:05

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012868

- Term: Skin Abnormalities

- ID: D000000013

- Term: Congenital Abnormalities

- ID: D000012873

- Term: Skin Diseases, Genetic

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000012871

- Term: Skin Diseases

- ID: D000012872

- Term: Skin Diseases, Vesiculobullous

- ID: D000003095

- Term: Collagen Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7976

- Name: Epidermolysis Bullosa

- Relevance: HIGH

- As Found: Epidermolysis Bullosa

- ID: M18586

- Name: Epidermolysis Bullosa Dystrophica

- Relevance: HIGH

- As Found: Epidermolysis Bullosa Dystrophica

- ID: M15672

- Name: Skin Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15676

- Name: Skin Diseases, Genetic

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M15675

- Name: Skin Diseases, Vesiculobullous

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2098

- Name: Epidermolysis Bullosa

- Relevance: HIGH

- As Found: Epidermolysis Bullosa

- ID: T1991

- Name: Dystrophic Epidermolysis Bullosa

- Relevance: HIGH

- As Found: Dystrophic Epidermolysis Bullosa

- ID: T4889

- Name: Recessive Dystrophic Epidermolysis Bullosa

- Relevance: HIGH

- As Found: Recessive Dystrophic Epidermolysis Bullosa

### Condition Browse Module - Meshes

- ID: D000004820

- Term: Epidermolysis Bullosa

- ID: D000016108

- Term: Epidermolysis Bullosa Dystrophica

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** LEAES Treatment

**Deaths Num At Risk:** 7

**Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein.

**ID:** EG000

**Other Num Affected:** 7

**Other Num at Risk:** 7

**Serious Number Affected:** 2

**Serious Number At Risk:** 7

**Title:** LEAES Treatment

**Frequency Threshold:** 0

#### Other Events

**Term:** Wound infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (Unspecified)

**Term:** Pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (Unspecified)

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** PAIN OF WOUND SITES

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (Unspecified)

**Term:** Wound complication

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Wound drainage

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (Unspecified)

**Term:** Postoperative hemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** CTCAE (Unspecified)

#### Serious Events

**Term:** Neoplasms benign, malignant and unspecified, squamous cell carcinoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (Unspecified)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 7

**Num Events:** 4

**Time Frame:** 2 years post receiving LEAES cell sheets

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 7

**Units:** Participants

### Group

**ID:** BG000

**Title:** LEAES Treatment

**Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein.

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 7

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 5

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 7

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** clinicalresults@abeonatherapeutics.com
**Organization:** Abeona Therapeutics
**Phone:** (216) 282-8150
**Title:** Chief Medical Officer
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35
**Title:** Global Score of 100% to 75%
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** Global Score of 74% to 50%
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** Global Score of 49% or less
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
**Title:** Global Score of 100% to 75%
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** Global Score of 74% to 50%
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** Global Score of 49% or less
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19
**Title:** Global Score of 100% to 75%
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** Global Score of 74% to 50%
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** Global Score of 49% or less
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
**Title:** Global Score of 100% to 75%
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** Global Score of 74% to 50%
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** Global Score of 49% or less
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 97.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 90
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 90.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 78.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 98
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 81.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 91.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 92
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 85.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 87.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 74.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 99
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 99
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.67
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 0
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89.45
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 99
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 97
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 98.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 81
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 73
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 92
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 85
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 79
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 74
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 78.56
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 78.67
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 98.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 92
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 76
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 78.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Participants
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 1
- **Group ID:** OG002
- **Value:** 1
**Units:** Wounds
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** Positive for NC2
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Negative for NC2
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Not done
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** Positive for NC2
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** Negative for NC2
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Not done
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** Positive for NC2
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** Negative for NC2
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** Not done
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** Positive for NC2
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** Negative for NC2
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** Not done
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** Positive for AFs
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** Negative for AFs
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Not done
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** Positive for AFs
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** Negative for AFs
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** Not done
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** Positive for AFs
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** Negative for AFs
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** Not done
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** Positive for AFs
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** Negative for AFs
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** Not done
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The graft site was clinically evaluated by the investigator with a global score of: 1) 100% to 75% healed, 2) 74% to 50% healed, 3) 49% or less healed with 100% meaning completely healed.
**Parameter Type:** COUNT_OF_UNITS
**Population Description:** The 7 participants who were determined to be eligible to receive LEAES cell sheets received 6 cell sheets to 6 wounds, each which were analyzed in this study as the primary endpoint.
**Reporting Status:** POSTED
**Time Frame:** 3, 6, 12 and 24 months post grafting
**Title:** Number of Wounds by Healing Category Per Investigator Visual Assessment
**Type:** PRIMARY
**Type Units Analyzed:** wounds
**Unit of Measure:** wounds
##### Group
**Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein.
**ID:** OG000
**Title:** LEAES Treatment
#### Outcome Measure 2
**Description:** Percentage of wound area will be obtained using the Canfield system. Changes in dimensions between visits as well as changes in dimensions from baseline will be recorded. Dimensions of untreated wounded skin will be used for comparison
**Parameter Type:** NUMBER
**Population Description:** The Canfield Imaging System was implemented after the first 2 participants received LEAES. Tattoos were not used when placing tattoos for these first 2 participants. Therefore, measurements using the Canfield Imaging System was not possible.
**Reporting Status:** POSTED
**Time Frame:** 3, 6 and 12 months post grafting
**Title:** Percentage Surface Area of Wound Healing
**Type:** PRIMARY
**Type Units Analyzed:** Wounds
**Unit of Measure:** percentage of wound area
##### Group
**Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein.
**ID:** OG000
**Title:** 3 Months Post LEAES Treatment
##### Group
**Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)
**ID:** OG001
**Title:** 6 Months Post LEAES Treatment
##### Group
**Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)
**ID:** OG002
**Title:** 12 Months Post LEAES Treatment
#### Outcome Measure 3
**Description:** Skin biopsies were obtained to evaluate expression of type VII collagen, NC2 epitope, using immuno-electron microscopy and immuno-fluorescent light microscopy.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The 7 participants who were determined to be eligible to receive LEAES cell sheets received 6 cell sheets to 6 wounds, each which were analyzed in this study as the primary endpoint.
**Reporting Status:** POSTED
**Time Frame:** 3 months, 6 months, 12 months, 24 months post-grafting
**Title:** Number Participants Positive for NC2 Epitope as a Measure of Duration of Type VII Collagen Production
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein.
**ID:** OG000
**Title:** LEAES Treatment
#### Outcome Measure 4
**Description:** Skin biopsies were obtained to observe physical development of the anchoring fibrils using electron microscopy
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The 7 participants who were determined to be eligible to receive LEAES cell sheets received 6 cell sheets to 6 wounds, each which were analyzed in this study as the primary endpoint.
**Reporting Status:** POSTED
**Time Frame:** 3 months, 6 months, 12 months and 24 months post grafting
**Title:** Number of Participants With Presence of Anchoring Fibrils (AF)
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** Participants
##### Group
**Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein.
**ID:** OG000
**Title:** LEAES Treatment
### Participant Flow Module
#### Group
**Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein.
**ID:** FG000
**Title:** LEAES Treatment
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Pre-Assignment Details:** 12 participants signed informed consent, 7 were allocated to the treatment arm.
**Has Results:** True