Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Critical Limb Ischemia

In brief

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).

Key facts

Study ID

NCT01410331

Run by

Juventas Therapeutics, Inc.

People needed

48

Starts

2012-03-01

Expected to finish

2014-07-01

Last updated by the study team

2014-10-23

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cardiology PC — Birmingham, Alabama, United States
• Northwestern Memorial Hospital/Northwestern University — Chicago, Illinois, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Summa Health System — Akron, Ohio, United States
• Medanta-The Medicity — Haryāna, India
• Sir Ganga Ram Hospital — New Delhi, India

Full record on ClinicalTrials.gov

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