Claudication Clinical Trial
Official title:
A Phase I Safety, Dose Escalating Study of MultiGeneAngio in Patients With Peripheral Arterial Disease
The purpose of this study is to evaluate the safety and activity of increasing doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with peripheral arterial disease.
Status | Active, not recruiting |
Enrollment | 12 |
Est. completion date | December 2024 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 80 Years |
Eligibility |
Inclusion Criteria: - History of exercise-limiting intermittent claudication and peripheral arterial disease with symptoms in one or both legs, of at least 2 months duration with no change in symptom severity in the 2 months prior to screening. - A Doppler-measured ankle-brachial index (ABI) of =0.80 or toe-brachial index (TBI) of <0.70 in at least one leg after 10 minutes of rest. - Limitation in walking secondary to claudication with a mean peak walking time (PWT) of between 1 and 10 minutes on a standardized Gardner protocol for exercise treadmill test (ETT). - Angiographic or equivalent anatomic evidence (MRA) of arterial occlusive disease (>70%) in the distal common femoral artery or superficial femoral artery and its branches of at least one leg within 12 months prior to screening. - Postmenopausal (females),surgically sterile, or use adequate birth control. Exclusion Criteria: - Presence of significant inflow disease [defined as >50% stenosis] in the distal aorta, common or external iliac as assessed by conventional angiogram, digital subtraction angiography (DSA), or magnetic resonance angiography (MRA) performed < 1 year prior to screening. - Critical limb ischemia, either chronic or acute ischemia manifested by rest pain, ulceration, or gangrene (Category 4 through 6 of Society for Vascular Surgery [SVS] classification [Rutherford]). - History of malignant neoplasm (except curable non-melanoma skin malignancies). - Renal failure (serum creatinine >2.0 mg/dL) or end-stage renal disease(requiring hemodialysis or renal replacement therapy). - Significant hepatic disease (>3-fold elevation in ALT/AST). - HBV or HCV carriers. - Severe pulmonary disease (e.g. severe chronic obstructive pulmonary disease). - Subjects with Acute Stroke within 6 months prior to screening. - Subjects with uncontrolled diabetes mellitus. - Specific ophthalmologic conditions that preclude retinal photography,vascular lesions of the anterior segment of the eye, proliferative retinopathy, age-related macular degeneration or intra-ocular surgery within 6 months prior to enrollment. - Gross obesity (BMI=40). - Buerger's disease or other forms of inflammatory arteritis. - Class IV congestive heart failure, as defined by the New York Heart Association or a myocardial infarction within 6 months prior to screening. - Subject with deep vein thrombosis within 3 months prior to screening. - Inability to complete the standardized treadmill protocol for reasons other than claudication including symptoms such as angina, dyspnea, joint pains, or excessive fatigue. - Percutaneous intervention or surgical revascularization in the index lower limb within 6 months prior to enrollment. - Heart angioplasty with or without stent or coronary bypass surgery within the past 6 months. - Participation in a structured exercise treatment protocol within 30 days prior to screen testing. - Subject is planning to participate in a structured exercise treatment protocol during the 180 days following administration of the investigational product. - Participation in a previous gene transfer trial in which the subject received active investigational product (placebo subjects are eligible). - Concurrent or prior participation in another clinical trial within 30 days prior to screen testing. - Chronic use of Cox-2 inhibitors, defined as subjects needing daily use of the agent for more than 30 days prior to screening. - Subject is taking any of the following drugs for life-threatening conditions or as part of a life-sustaining treatment: Cyclosporine (Sandimmune®),Systemic androgens/anabolic steroids, systemic corticosteroids. - History of bleeding diathesis (e.g. hemophilia due to Factor VIII or IX deficiency). - Pregnancy or breast-feeding. - Uncontrolled hypertension or significant hypotension. - Immunodeficiency states (e.g, current HIV positivity, or organ transplant recipient) or subject receiving immunosuppressive medications. - Alcohol or other substance abuse. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan and VA Ann Arbor Health Systems | Ann Arbor | Michigan |
United States | University of Pennsylvania Health System | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
MultiGene Vascular Systems Ltd. |
United States,
Staudacher DL, Preis M, Lewis BS, Grossman PM, Flugelman MY. Cellular and molecular therapeutic modalities for arterial obstructive syndromes. Pharmacol Ther. 2006 Jan;109(1-2):263-73. Epub 2005 Oct 21. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The safety of MultiGeneAngio will be assessed by monitoring adverse events | Up to 15 years after treatment | Yes | |
Secondary | Improvement in PAD symptoms | Up to one year after treatment | No |
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