Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390767
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2015-03-05
First Post:
2006-10-19
Brief Title:
Safety Study of MultiGeneAngio in Patients With Peripheral Arterial Disease PAD
Sponsor:
MultiGene Vascular Systems Ltd
Organization:
MultiGene Vascular Systems Ltd
Study Overview
Official Title:
A Phase I Safety Dose Escalating Study of MultiGeneAngio in Patients With Peripheral Arterial Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and activity of increasing doses of MultiGeneAngio a cell therapy product produced from the patients own cells as potential treatment for patients with peripheral arterial disease
Detailed Description:
Approximately 16 million patients worldwide 1 in 20 people over the age of 50 suffer from peripheral arterial diseasePAD PAD is characterized by narrowing or occlusion of vessels supplying blood to the lower limbs most often due to atherosclerosis Symptoms of PAD include claudication that may progress to critical limb ischemia manifested by rest pain tissue loss and gangrene which eventually may necessitate amputation
MultiGeneAngio is a cell therapy-based product developed for treatment of patients with PAD secondary to narrow or blocked arteries in the legs MultiGeneAngio is composed of endothelial and smooth muscle cells that are isolated from a short vein segment stripped from the patients arm After isolation the cells are expanded characterized and gene modified by transfer of angiogenic genes
MultiGeneAngio is a clear cell suspension injected intra-arterially at the site of blockage using a standard diagnostic catheter in order to create and expand new collateral arteries and thereby improve blood flow to an ischemic limb
Comprehensive pre-clinical studies as well as clinical experience with PAD patients suffering from claudication showed that production and administration of MultiGeneAngio was feasible and safe as no apparent drug-related adverse events have been observed Moreover follow-up data of peak walking times imply a beneficial trend of this efficacy end-point Additional follow-up data will continue to be collected to help evaluate the safety and efficacy of MultiGeneAngio
MultiGeneAngio is a cell therapy-based product developed for treatment of patients with PAD secondary to narrow or blocked arteries in the legs MultiGeneAngio is composed of endothelial and smooth muscle cells that are isolated from a short vein segment stripped from the patients arm After isolation the cells are expanded characterized and gene modified by transfer of angiogenic genes
MultiGeneAngio is a clear cell suspension injected intra-arterially at the site of blockage using a standard diagnostic catheter in order to create and expand new collateral arteries and thereby improve blood flow to an ischemic limb
Comprehensive pre-clinical studies as well as clinical experience with PAD patients suffering from claudication showed that production and administration of MultiGeneAngio was feasible and safe as no apparent drug-related adverse events have been observed Moreover follow-up data of peak walking times imply a beneficial trend of this efficacy end-point Additional follow-up data will continue to be collected to help evaluate the safety and efficacy of MultiGeneAngio
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 |
|---|---|---|---|
| Protocol 0504-703 NIH RAC | OTHER | NIH | None |