Safety Study of VCT-01™ in Split-Thickness Skin Graft Donor Site Wounds

NCT ID: NCT01292122

Last Updated: 2012-12-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-09-30

Brief Summary

The purpose of this study is to evaluate the safety of VCT-01 in split-thickness skin graft (STSG) donor site wounds and assess selected parameters of healing at the VCT-01-treated donor site.

Detailed Description

An initial cohort of 5 subjects will be allocated to Group A. When all subjects enrolled in Group A have completed 14 days of post-treatment follow-up, results of donor site evaluations, histological analyses and reported adverse events will be reviewed by the Investigator and study Sponsor. If the data is suggestive of clinical benefit following treatment and absent any serious and/or unexpected adverse events, which are, in the opinion of the investigator, related to the treatment, the remaining subjects will be enrolled and randomized to Groups B, C or D.

Conditions

Wounds

Keywords

Wounds; Grafts; Wound Healing; Cell Therapy; Split-thickness skin graft donor site wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VCT-01-treated STSG donor site wound

Application of VCT-01 to STSG donor site wound at Day 0

Group Type: EXPERIMENTAL

VCT-01

Intervention Type: DEVICE

Application of bi-layered living cell-based product (VCT-01) to STSG donor site wound at Day 0

Interventions

VCT-01

Application of bi-layered living cell-based product (VCT-01) to STSG donor site wound at Day 0

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is at least 18 years of age but no more than 55 years of age.

2. Subject has a primary wound which requires treatment with a split-thickness skin graft; the graft cannot be harvested from a site from which a skin graft was previously obtained. If the primary wound is a result of a thermal or chemical burn, the total body surface area must be less than 15%.

3. Females of childbearing potential must have a documented negative urine pregnancy test and must agree to use highly effective contraceptives for 6 months post-treatment.

4. Subject has read, understood and signed a Health Research Ethics Board-approved Informed Consent Form.

5. Subject is able and willing to comply with study procedures and instructions.

Exclusion Criteria

1. Female subjects who are pregnant or lactating.

2. Clinically significant disease or condition that may compromise graft take and/or donor site healing (e.g. the presence of a bleeding disorder, capillary fragility, venous or arterial disorder directly affecting the donor site to be treated, known or suspected systemic malignancies, human immunodeficiency virus infection, renal or liver disease, uncontrolled diabetes mellitus, thrombocytopenia, vasculitis, poor nutritional status).

3. Subjects who are currently receiving or have received within two months prior to treatment: systemic, inhaled or intranasal corticosteroids or immunosuppressant agents. Subjects receiving therapeutic doses of anticoagulants for pre-existing medical conditions (e.g. Plavix, Coumadin, Heparin, low molecular weight Heparin, non-steroidal anti-inflammatory drugs, herbal supplements), for whom a dose interruption from Screening through 2-Months post-treatment (pre-treatment / treatment / biopsy phase) is contraindicated, are excluded from the study.

4. Any disorder (psychiatric, alcohol or substance abuse [within 12 months of treatment], physical disability) that might interfere with obtaining informed consent or the subject's ability to comply with study or protocol requirements, as determined by the Investigator.

5. Subjects who have used any tobacco product within 3 months prior to treatment.

6. Subjects previously treated with Apligraf®, Dermagraft or any other cell-based product, including autologous tissue at the treatment site.

7. Subjects who have received an investigational drug, device or biological/bioactive treatment within 30 days prior to treatment (medical or dental).

8. Subjects, who in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

9. Subjects, as determined by Screening immunology testing, that have specific antibodies to VCT-01 donor cell human leukocyte antigens.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organogenesis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward E Tredget, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

10-GDS-001-VCT

Identifier Type: -

Identifier Source: org_study_id