Safety Study of MultiGeneAngio in Patients With Peripheral Arterial Disease (PAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00390767|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2006
Last Update Posted : March 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|PAD Claudication||Biological: MultiGeneAngio||Phase 1 Phase 2|
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 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Safety, Dose Escalating Study of MultiGeneAngio in Patients With Peripheral Arterial Disease|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2024|
Escalating doses of MultiGeneAngio
Escalating doses of MultiGeneAngio, one dose per patient administered as one treatment, infused intra-arterially
Other Name: MGA
- The safety of MultiGeneAngio will be assessed by monitoring adverse events [ Time Frame: Up to 15 years after treatment ]
- Improvement in PAD symptoms [ Time Frame: Up to one year after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390767
|United States, Michigan|
|University of Michigan and VA Ann Arbor Health Systems|
|Ann Arbor, Michigan, United States, 48109-0311|
|United States, Pennsylvania|
|University of Pennsylvania Health System|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Study Director:||Sam L Teichman, MD||Independent consultant|