Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia
Lead Sponsor:
Juventas Therapeutics, Inc.
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
This is a double-blind, placebo controlled study designed to evaluate the safety and efficacy of JVS-100 given to adult subjects with critical limb ischemia (CLI).
Detailed Description
48 subjects diagnosed with Rutherford Class 4-5 Critical Limb Ischemia (CLI) with non-healing ulcers and/or ischemic rest pain will be enrolled in this study designed to investigate the safety and eff...
Eligibility Criteria
Inclusion
- Men and women 40 years of age or older
- Rutherford Category 4 or 5
- Ankle systolic pressure of 70mmHg or less, or toe pressure of 50mmHg or less
- Poor option for surgical revascularization by open or endovascular strategies
- Those diabetic subjects who are on optimal diabetes treatment, with HbA1c \<8.5 %
- Subject should be on stable therapy for the treatment of CLI, including statin and antiplatelet therapy
- Subject must be willing to forgo treatment with hyperbaric oxygen, nerve stimulation, ot sympathectomy for treatment of CLI 10 days prior to 45 days following injection of study drug
Exclusion
- Life expectancy of less than 1 year
- Previous major amputation of the leg to be treated or planned major amputation within the first month following enrollment
- Patent revascularization (within 6 weeks)in the leg to be treated prior to enrollment
- NYHA Class IV heart failure
- Evidence of osteomyelitis or active infection
- Subjects with Buerger's Disease
- Subjects with a history of Systemic Lupus Erythematosus (SLE) flare
- Subjects with established chronic kidney (stage 5) requiring dialysis
- Uncontrolled blood pressure
- Significant hepatic disease
- Diabetic subjects with active proliferative retinopathy
- Immunodeficient states or subjects receiving chronic immunosuppressive therapy
- Any patient with a history of cancer unless 1)the cancer was limited to curable non-melanoma skin malignancies, or 2)the cancer was removed by successful tumor resection, with or without radiation or chemotherapy, 5 years or more prior to enrollment in this study without recurrence
- Pregnant or lactating women or subjects of childbearing potential not protected by an effective method of birth control
- Men unwilling to agree to barrier contraception or limit sexual activity
- Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
- Acute coronary syndrome within 3 month prior to enrollment
- Previous treatment with angiogenic growth factors or with stem cell therapy within 1 year
- Participation in another clinical trial in the last 30 days
- Clinically significant elevations in PT/PTT/INR
- Non-heel wound size \>20 cm2 (excluding toe gangrene) or heel wound size \>10cm2 on the index limb
- History of drug or alcohol abuse in the last year
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01410331
Start Date
March 1 2012
End Date
July 1 2014
Last Update
October 23 2014
Active Locations (7)
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1
Cardiology PC
Birmingham, Alabama, United States, 35211
2
Northwestern Memorial Hospital/Northwestern University
Chicago, Illinois, United States, 60611
3
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
4
Montefiore Medical Center
The Bronx, New York, United States, 10467