Status:
COMPLETED
Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia
Lead Sponsor:
Pluristem Ltd.
Conditions:
Peripheral Artery Disease
Peripheral Vascular Disease
Eligibility:
All Genders
40-81 years
Phase:
PHASE1
Brief Summary
The The purpose of this study is to determine the safety of PLX-PAD single dose, Intra-muscular injection for the treatment of CLI patients.
Detailed Description
PLX-PAD are mesenchymal-like stromal cells derived from a full term placenta, termed PLX-PAD, and intended for the treatment of Critical Limb Ischemia
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 \< 0.4 or/and TBI \< 0.4 or transcutaneous partial pressure of oxygen ≤ 30 mmHg pO2 at the foot.
- Rutherford category 4-5
- No acceptable options for re-vascularisation as confirmed by angiographic imaging results or by color flow duplex ultrasound obtained within 6 months prior screening visit and signed approval of vascular surgeon.
- In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.
Exclusion
- Uncontrolled hypertension (defined as diastolic blood pressure \> 110 mmHg or systolic blood pressure \> 180 mmHg during screening).
- Poorly controlled diabetes mellitus (HbA1c \> 9%)
- Wounds with severity greater than Grade 2 on the Wagner Scale
- Life-threatening ventricular arrhythmia - except if an ICD is implanted - or unstable angina pectoris - 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 :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00919958
Start Date
June 1 2009
End Date
June 1 2012
Last Update
June 19 2012
Active Locations (1)
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1
Franziskus-Krankenhaus
Berlin, Germany