HemaTrate™ in the Treatment of Critical Limb Ischemia

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is comparing the percentage of patients between the treatment arm and control arm who have freedom from major amputation, arterial intervention below the knee, and death through 12 months.

Official Title
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Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia

Conditions
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Critical Limb Ischemia, Ischemia

Intervention / Treatment
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* Device: HemaTrate™ Blood Filtration system
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5) Previously failed an endovascular or surgical treatment of the study lower leg and is not being considered for additional intervention within the next 3 months OR is unsuitable for revascularization Exclusion Criteria: Simultaneously participating in another investigational study (e.g., drug or device) Pregnant or breastfeeding, or planning to become pregnant within the next 12 months Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days Endovascular intervention within the past 30 days Current dialysis, or expected to need dialysis within the next 12 months Previous above the ankle amputation in the study leg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals. | Device: HemaTrate™ Blood Filtration system<br>* Anticoagulated whole blood is loaded into the filtration system. During gravity filtration, the majority of platelets, plasma, and red blood cells pass through the filter into a filtrate bag. The TNCs are captured in the filter material and recovered via a back-flush with 0.9 % saline into a syringe.<br>|
| Placebo Comparator: Saline (Control Arm)<br>Patients assigned to the control arm will be injected with saline three times at six week intervals. | Other: Saline<br>* Normal (0.9%) saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from vascular or endovascular arterial intervention below the knee of the study leg | Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg | 12 months | 
| Freedom from major amputation of the study leg | Percent of patients that have any amputation above the ankle of the study leg | 12 months | 
| Death | Percent of patients that exit due to death | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, lower extremity, Ischemia, Peripheral Blood Stem Cell Transplantation, Leukocytes, Mononuclear, Transplantation, Autologous