HemaTrate™ in the Treatment of Critical Limb Ischemia

Cook Group

Status: Terminated

Conditions: Critical Limb Ischemia; Ischemia

Treatments: Device: HemaTrate™ Blood Filtration system; Other: Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT03809494

15-03

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5)
2. 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

1. Simultaneously participating in another investigational study (e.g., drug or device)
2. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months
3. Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days
4. Endovascular intervention within the past 30 days
5. Current dialysis, or expected to need dialysis within the next 12 months
6. Previous above the ankle amputation in the study leg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups, including a placebo group

Treatment Arm

Experimental group

Description:

Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals.

Treatment:

Device: HemaTrate™ Blood Filtration system

Saline (Control Arm)

Placebo Comparator group

Description:

Patients assigned to the control arm will be injected with saline three times at six week intervals.

Treatment:

Other: Saline