Status:
ACTIVE_NOT_RECRUITING
Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia
Lead Sponsor:
MultiGene Vascular Systems Ltd.
Conditions:
Peripheral Arterial Disease
Peripheral Vascular Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00956332
Start Date
February 1 2010
End Date
May 1 2026
Last Update
March 5 2015
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Barzilai Medical Center
Ashkelon, Israel, 78278
2
Soroka Medical Center
Beersheba, Israel, 84101
3
Rambam Medical Center
Haifa, Israel, 31096
4
Shaare Zedek Medical Center
Jerusalem, Israel, 91031