Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.

Official Title
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Phase I Study of Intramuscular (IM) Injections of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia. PLX-PAD Are Mesenchymal-Like Stromal Cells Derived From a Full Term Placenta.

Conditions
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Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia

Intervention / Treatment
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* Biological: PLX-PAD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLX-PAD low dose<br>IM injection Single treatment; multiple injections | Biological: PLX-PAD<br>* IM injection<br>|
| Experimental: PLX-PAD high dose<br>IM injection Double treatment; multiple injections | Biological: PLX-PAD<br>* IM injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events; Amputation incidence, Death incidence & Rehospitalization incidence |  | 3 months | 
| Immunological reaction |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Artery Disease, Peripheral Vascular Disease, Critical limb ischemia, PAD, CLI