Status:
COMPLETED
Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)
Lead Sponsor:
Pluristem Ltd.
Conditions:
Peripheral Artery Disease
Peripheral Vascular Disease
Eligibility:
All Genders
40-81 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.
Eligibility Criteria
Inclusion
- Diagnosis of critical limb ischemia defined as persistent, recurring ischemic rest pain for at least two (2) weeks, and/or ulceration or gangrene of the foot or toe, with ABI \< 0.6 or/and TBI \< 0.4
- Rutherford category 4-5
- Non candidate for revascularization or endovascular intervention based on unfavorable vascular anatomy or significant co-morbid medical conditions as confirmed by vascular study (e.g., angiogram, MRA) obtained within 3 months prior screening visit and signed approval of vascular surgeon. The decision to classify the subject as a non-candidate will be made by the investigator and confirmed by an independent third party vascular surgeon who is not participating in the study.
- In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.
- Those diabetic subjects who are on optimal diabetes medication, with an HbA1c \< 8%
Exclusion
- Uncontrolled hypertension (defined as diastolic blood pressure \> 110 mmHg or systolic blood pressure \> 180 mmHg during screening).
- Wounds with severity greater than Grade 2 on the Wagner Scale
- Life-threatening ventricular arrhythmia - except if an ICD is implanted - or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged.
- ST segment elevation myocardial infarction and/or TIA/CVA within six (6) months prior to enrollment.Patients with severe congestive heart failure (i.e. NYHA Stage IV)
- In the opinion of the investigator, the patient is unsuitable for cellular therapy.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00951210
Start Date
August 1 2009
End Date
October 1 2011
Last Update
May 27 2015
Active Locations (2)
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1
Cardiology PC
Birmingham, Alabama, United States, 35211
2
Duke University Medical Center
Durham, North Carolina, United States, 27710