Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)
Completed · Phase 1
Conditions studied: Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
In brief
The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.
Key facts
- Study ID
- NCT00951210
- Run by
- Pluristem Ltd.
- People needed
- 12
- Starts
- 2009-08-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2015-05-27
Who can join
Age: 40 and older, up to 81. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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.
Where it is running
- Cardiology PC — Birmingham, Alabama, United States
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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