Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065663
Status:
COMPLETED
Last Update Posted:
2007-11-20
First Post:
2003-07-30
Brief Title:
Gene Therapy to Improve Wound Healing in Patients With Diabetes
Sponsor:
Tissue Repair Company
Organization:
Tissue Repair Company
Study Overview
Official Title:
Growth Factor Gene Therapy for Wound Healing
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with diabetes may develop chronic wounds that respond poorly to treatment Gene therapy with the platelet-derived growth factor-B gene has been shown to help with the healing of chronic wounds This study will evaluate a new way to deliver the gene to the wound tissue
Detailed Description:
Chronic wounds such as diabetic ulcers pressure ulcers and venous stasis ulcers cause significant morbidity in millions of patients each year in the United States Individuals with long-standing diabetes develop both peripheral vascular disease and peripheral neuropathy These patients may not feel pressure from shoes or objects which can damage their skin Once a wound is formed it may heal very slowly or not at all due to diabetic complications
Platelet-derived growth factor-B PDGF-B has been approved for use in diabetic ulcers However delivery and maintenance of the drug at the wound site in sufficient quantities for a sufficient period of time is a major hurdle to widespread use
Gene activated matrix GAM technology offers the opportunity to place a therapeutic gene contained within a structural matrix into a wound site This study will evaluate the safety and potential clinical utility of topical applications of GAM501 a gene for PDGF-B contained within an E1-deleted adenoviral vector and formulated in a bovine type I collagen gel This formulation allows for the migration of wound repair cells into the structural matrix where they encounter the viral vector and subsequently produce the therapeutic protein within the local wound environment
Participants in this study will receive up to four treatments with GAM501 Participants will be followed by multiple observations over a 6 to 7 month period
Platelet-derived growth factor-B PDGF-B has been approved for use in diabetic ulcers However delivery and maintenance of the drug at the wound site in sufficient quantities for a sufficient period of time is a major hurdle to widespread use
Gene activated matrix GAM technology offers the opportunity to place a therapeutic gene contained within a structural matrix into a wound site This study will evaluate the safety and potential clinical utility of topical applications of GAM501 a gene for PDGF-B contained within an E1-deleted adenoviral vector and formulated in a bovine type I collagen gel This formulation allows for the migration of wound repair cells into the structural matrix where they encounter the viral vector and subsequently produce the therapeutic protein within the local wound environment
Participants in this study will receive up to four treatments with GAM501 Participants will be followed by multiple observations over a 6 to 7 month period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44AR046154 | NIH | None | httpsreporternihgovquickSearchR44AR046154 |