Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the safety and activity of two doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with chronic critical limb ischemia.
Peripheral Arterial Disease
Peripheral Vascular Disease
Chronic Critical Limb Ischemia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/IIa Safety, Two-dose Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia|
- The safety of MultiGeneAngio will be assessed by monitoring adverse events [ Time Frame: Up to 15 years after treatment ] [ Designated as safety issue: Yes ]
- Improvement in critical limb ischemia symptoms [ Time Frame: Up to 3 months after treatment ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||May 2026|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
|Experimental: MGA - Low therapeutic dose||
Low-therapeutic dose of MultiGeneAngio in suspension administered as one treatment, intra-arterially
|Experimental: MGA - Intermediate therapeutic dose||
Intermediate-therapeutic dose of MultiGeneAngio in suspension administered as one treatment, intra-arterially
Approximately 16 million patients worldwide (1 in 20 people over the age of 50) suffer from peripheral arterial disease(PAD). 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 chronic critical limb ischemia due to narrow or blocked leg arteries. MultiGeneAngio is composed of endothelial and smooth muscle cells that are isolated from a short vein segment harvested from the patient's 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.
|Barzilai Medical Center|
|Ashkelon, Israel, 78278|
|Soroka Medical Center|
|Be'er Sheva, Israel, 84101|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Hadassah University Hospital, Ein Kerem|
|Jerusalem, Israel, 91120|
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 91031|
|Kaplan Medical Center|
|Rehovot, Israel, 76100|
|Chaim Sheba Medical Center|
|Tel-Hashomer, Israel, 52621|
|Study Director:||Sam L. Teichman, MD||Independent consultant|