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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Juventas Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01410331
First received: July 14, 2011
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention Phase
Critical Limb Ischemia
Biological: JVS-100(4 mg) or placebo/8 injections
Biological: JVS-100(8 mg) or placebo/8 injections
Biological: JVS-100(8 mg) or placebo/16 injections
Biological: JVS-100(16 mg) or placebo/16 injections
Phase 2

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

Further study details as provided by Juventas Therapeutics, Inc.:

Primary Outcome Measures:
  • To Investigate the safety and tolerability of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Safety assessments include tracking of AEs and SAEs and laboratory assessments


Secondary Outcome Measures:
  • To investigate the initial efficacy of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Efficacy measurements include: tracking of major/minor amputations,overall survival,Quality of Life,ulcer healing, & pressure assessments.


Estimated Enrollment: 48
Study Start Date: March 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Subjects will be randomized to receive either 4 mg of JVS-100 or placebo over 8 injections.
Biological: JVS-100(4 mg) or placebo/8 injections
4 mg of JVS-100 or placebo delivered in 8 injections
Experimental: Cohort 2
Subjects will be randomized to receive either 8 mg of JVS-100 or placebo over 8 injections.
Biological: JVS-100(8 mg) or placebo/8 injections
8 mg of JVS-100 or placebo delivered in 8 injections
Experimental: Cohort 3
Subjects will be randomized to receive either 8 mg of JVS-100 or placebo over 16 injections.
Biological: JVS-100(8 mg) or placebo/16 injections
8 mg of JVS-100 or placebo delivered in 16 injections
Experimental: Cohort 4
Subjects will be randomized to receive either 16 mg of JVS-100 or placebo over 16 injections.
Biological: JVS-100(16 mg) or placebo/16 injections
16 mg of JVS-100 or placebo delivered in 16 injections

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 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410331

Locations
United States, Alabama
Cardiology PC
Birmingham, Alabama, United States, 35211
United States, Illinois
Northwestern Memorial Hospital/Northwestern University
Chicago, Illinois, United States, 60611
United States, Minnesota
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
India
Medanta-The Medicity
Haryana, India, 122001
Sir Ganga Ram Hospital
New Delhi, India, 110060
Sponsors and Collaborators
Juventas Therapeutics, Inc.
Investigators
Principal Investigator: Melina Kibbe, MD Northwestern University
  More Information

No publications provided

Responsible Party: Juventas Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01410331     History of Changes
Other Study ID Numbers: JTCS-002
Study First Received: July 14, 2011
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration
India: Ministry of Health

Keywords provided by Juventas Therapeutics, Inc.:
CLI
peripheral vascular disease
PVD
PAD
SDF-1

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014