Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia

Study Overview
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Brief Summary
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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
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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

Official Title
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Phase I Study of Intramuscular (IM) Injection 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. These Placental Adherent Stromal Cells (ASCs) Are Expanded in the Company's Proprietary PluriXTM 3D Bioreactor System. PLX Cells Are Immune Privileged and Possess Immunomodulatory Properties.

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

Intervention / Treatment
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* Biological: PLX-PAD IM injection


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 < 0.4 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 Criteria: 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.

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> | Biological: PLX-PAD IM injection<br>* Single treatment; multiple injections<br>|
| Experimental: PLX-PAD intermediate dose<br> | Biological: PLX-PAD IM injection<br>* Single treatment; multiple injections<br>|
| Experimental: PLX-PAD high dose<br> | Biological: PLX-PAD IM injection<br>* Single treatment; multiple injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, Safety laboratory values and ECG findings |  | 3 months | 
| Immunological reaction |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumorigenesis |  | 24 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