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

Critical Limb Ischemia Clinical Trial

Official title:

A Phase II, Randomized, Double-Blind, Placebo Controlled Dose Escalation Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection to Cohorts of Adults With Critical Limb Ischemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410331
• Other study ID #: JTCS-002
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2011
• Last updated: October 22, 2014
• Start date: March 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2014
• Source: Juventas Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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 efficacy of JVS-100. JVS-100 will be delivered by direct intramuscular injection into the limbs of study subjects. Subjects will be randomized to receive a single set of direct intramuscular injections of either JVS-100 or vehicle control and will be followed for 12 months post dosing. Safety and efficacy assessments will be collected at 3 days, 4 weeks and 3, 6 and 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Biological:
• JVS-100(4 mg) or placebo/8 injections
4 mg of JVS-100 or placebo delivered in 8 injections
• JVS-100(8 mg) or placebo/8 injections
8 mg of JVS-100 or placebo delivered in 8 injections
• JVS-100(8 mg) or placebo/16 injections
8 mg of JVS-100 or placebo delivered in 16 injections
• JVS-100(16 mg) or placebo/16 injections
16 mg of JVS-100 or placebo delivered in 16 injections

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Juventas Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Investigate the safety and tolerability of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI.	Safety assessments include tracking of AEs and SAEs and laboratory assessments	12 Months	Yes
Secondary	To investigate the initial efficacy of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI.	Efficacy measurements include: tracking of major/minor amputations,overall survival,Quality of Life,ulcer healing, & pressure assessments.	6 months	No