Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MultiGene Vascular Systems Ltd.
ClinicalTrials.gov Identifier:
NCT00956332
First received: August 9, 2009
Last updated: May 1, 2013
Last verified: May 2013

August 9, 2009
May 1, 2013
February 2010
August 2011   (final data collection date for primary outcome measure)
The safety of MultiGeneAngio will be assessed by monitoring adverse events [ Time Frame: Up to 15 years after treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00956332 on ClinicalTrials.gov Archive Site
Improvement in critical limb ischemia symptoms [ Time Frame: Up to 3 months after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia
Phase I/IIa Safety, Two-dose 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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral Arterial Disease
  • Peripheral Vascular Disease
  • Chronic Critical Limb Ischemia
  • Biological: MultiGeneAngio
    Low-therapeutic dose of MultiGeneAngio in suspension administered as one treatment, intra-arterially
  • Biological: MultiGeneAngio
    Intermediate-therapeutic dose of MultiGeneAngio in suspension administered as one treatment, intra-arterially
  • Experimental: MGA - Low therapeutic dose
    Intervention: Biological: MultiGeneAngio
  • Experimental: MGA - Intermediate therapeutic dose
    Intervention: Biological: MultiGeneAngio

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
28
May 2026
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women 50 years of age or older
  • Ischemic rest pain (Rutherford category 4) and/or
  • Non-healing wounds (Rutherford category 5)
  • ABI of 0.5 or less, or TBI of 0.3 or less
  • Ankle systolic pressure of 70 mm Hg or less, or toe systolic pressure of 50 mm Hg or less
  • Poor or no option for conventional revascularization

Exclusion Criteria:

  • Life expectancy of less than one year
  • Presence of significant inflow disease (>50% stenosis) in the distal aorta, common or external iliac
  • Advanced CLI, characterized by extensive tissue loss or gangrene (Rutherford category 6)
  • Previous major amputation on the leg to be treated or planned major amputation within a month from enrollment
  • Evidence of osteomyelitis
  • Ischemic wounds with uncontrolled infectious symptoms
  • Heart angioplasty or CABG within 3 months prior to enrollment
  • Severe congestive heart failure (New York Heart Association stage IV)
  • Acute cardiovascular event within 3 months prior to enrollment
  • Uncontrolled blood pressure: SBP≥ 180 mmHg or DBP ≥110 mmHg
  • Known Buerger's disease
  • History of bleeding diathesis (e.g., hemophilia due to Factor VIII or IX deficiency)
  • Renal failure defined as a serum creatinine >2.5mg/dL
  • Significant hepatic disease:>3-fold elevation in ALT/AST, HBV or HCV carriers
  • Severe pulmonary disease
  • Active proliferative retinopathy and/or severe macular oedema
  • Intra-ocular surgery within 6 months prior to enrollment
  • Immunodeficient states (e.g. known HIV positivity, or organ transplant recipient) or subject receiving immunosuppressive medication
  • History of malignant neoplasm (except curable non-melanoma skin malignancies) within 5 years prior to enrollment
  • Pregnant or lactating women
  • Previous treatment with angiogenic growth factors or stem cells
  • No demonstrable venous access
  • Known hypersensitivity to VEGF, Angiopoietin-1, or heparin
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00956332
MGVS-MGA 002
Yes
MultiGene Vascular Systems Ltd.
MultiGene Vascular Systems Ltd.
Not Provided
Study Director: Sam L. Teichman, MD Independent consultant
MultiGene Vascular Systems Ltd.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP