A clinical trial to study the safety and initial efficacy of JVS-100 given through Intramuscular injection in adult patients with Critical Limb Ischemia
- Conditions
- Health Condition 1: null- Critical Limb IschemiaHealth Condition 2: M622- Nontraumatic ischemic infarction of muscle
- Registration Number
- CTRI/2011/11/002177
- Lead Sponsor
- Juventas Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 48
1)Men or women 40 years of age or older
2)Rutherford category 4 or 5
a)Subjects with focal gangrene on the big toe of the ischemic leg will also be considered for enrollment
3)Ankle systolic pressure of 70 mm Hg or less, or toe systolic pressure of 50 mm Hg or less
a)Note: For subjects with absolute ankle and toe pressures in the affected limb that are unreliable (e.g., non-compressible arteries due to calcification) or unattainable (e.g., non-healing ulcers on ankle or great toe which prevent this assessment), there must be documentation of a clinical diagnosis of Rutherford Class 4 or 5 Critical Limb Ischemia and angiographic evidence of the total occlusion of the superficial femoral, popliteal or at least one of the infra-popliteal arteries.
4)Poor option for surgical revascularization by open or endovascular strategies as determined by the treating physician. A narrative documenting the reason why the subject is a poor candidate for revascularization must be included in the subjects medical record
5)Those diabetic subjects who are on optimal diabetes medication, with HbA1c < 8.5%
6)Subject should be on stable medical therapy for the treatment of CLI, including statin and anti platelet therapy unless there is documented contraindication or intolerance to these therapies
7)Subject must be willing to forego treatment with hyperbaric oxygen, nerve stimulation or sympathectomy for the treatment of CLI from 10 days prior to 45 days following injection of study drug
8)Willing and able to sign informed consent
1)Life expectancy of less than one year
2)Previous major amputation of the leg to be treated or planned major amputation within the first month following enrollment
3)Patent revascularization (within 6 weeks) in the leg to be treated prior to enrollment
4)NYHA Class IV heart failure
5)Evidence of osteomyelitis or active infection
6)Uncontrolled blood pressure defined as SBP>= 180 mmHg or DBP >=110 mmHg despite adequate antihypertensive treatment at time of screening or enrollment
7)Significant hepatic disease (defined as >3-fold elevation in ALT/AST), HBV or HCV carriers
8)Diabetic subjects with active proliferative retinopathy
9)Immunodeficient states (e.g. known HIV positivity, or organ transplant recipient) or subject receiving chronic immunosuppressive therapy. Subjects receiving steroid inhalers are allowed.
10)Any patient with a history of cancer will be excluded unless:
a)The cancer was limited to curable non-melanoma skin malignancies
and/or
b)The cancer was removed by a successful tumor resection, with or without radiation or chemotherapy treatment, 5 years or more prior to enrollment in this study without recurrence.
11)Pregnant or lactating women or subjects of childbearing potential not protected by an effective method of birth control (see section 8.2.1 for list of effective methods)
12)Men unwilling to agree to barrier contraception or limit sexual activity
13)Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
14)Acute coronary syndrome within 3 months prior to enrollment
15)Previous treatment with angiogenic growth factors or with stem cell therapy within 1 year
16)Participation in another clinical trial in the last 30 days
17)Clinically significant elevations in PT/PTT/INR as judged by the site investigator
18)Non-heel wound size > 20cm2 (excluding toe gangrene) or heel would size >10cm2 on the index leg as measured by the Wound Core Lab from photograph and/or acetate tracing collecte at acreening
19)History of drug or alcohol abuse within the last year
20)Participation in another clinical trial in the last 30 days
21)Any subject who is unfit for the trial based on the discretion of the site Principal Investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method