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

NCT01292122 | Terminated

• 1 other identifier: 10-GDS-001-VCT
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events and changes from Baseline Immunology at 1, 3, 6 and 12 Months

  Frequency and severity of reported adverse events and changes in results of immunology testing at Months 1, 3, 6 and 12 post-treatment as compared to baseline testing

  Up to 12 months post-treatment

Secondary Outcomes (5)

• Healing parameter

  Day 4 post-treatment

• Healing parameter

  Day 14 post-treatment

• Healing parameter

  Up to 10 days post-treatment

• Healing parameter

  Up to 10 days post-treatment

• Healing parameter

  Up to 12 Months post-treatment

Study Arms (1)

VCT-01-treated STSG donor site wound

EXPERIMENTAL

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

Device: VCT-01

Interventions

VCT-01 DEVICE

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

VCT-01-treated STSG donor site wound

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is at least 18 years of age but no more than 55 years of age.
• 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%.
• 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.
• Subject has read, understood and signed a Health Research Ethics Board-approved Informed Consent Form.
• Subject is able and willing to comply with study procedures and instructions.

You may not qualify if:

• Female subjects who are pregnant or lactating.
• 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).
• 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.
• 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.
• Subjects who have used any tobacco product within 3 months prior to treatment.
• Subjects previously treated with Apligraf®, Dermagraft or any other cell-based product, including autologous tissue at the treatment site.
• Subjects who have received an investigational drug, device or biological/bioactive treatment within 30 days prior to treatment (medical or dental).
• 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.
• Subjects, as determined by Screening immunology testing, that have specific antibodies to VCT-01 donor cell human leukocyte antigens.

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Edward E Tredget, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: February 9, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

CA (1)