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HemaTrate™ in the Treatment of Critical Limb Ischemia

NCT ID: NCT03809494

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-23

Study Completion Date

2020-11-27

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.

Detailed Description

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Conditions

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Critical Limb Ischemia Ischemia

Keywords

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lower extremity Peripheral Arterial Disease Ischemia Peripheral Blood Stem Cell Transplantation Leukocytes, Mononuclear Transplantation, Autologous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The investigator for this study is the person that will be performing the injections throughout the study and will know the participant's treatment (TNC or saline). The investigator that is aware of the participant's treatment will not be performing the follow-up visits.

Study Groups

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Treatment Arm

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

Group Type EXPERIMENTAL

HemaTrate™ Blood Filtration system

Intervention Type DEVICE

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.

Saline (Control Arm)

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Normal (0.9%) saline

Interventions

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HemaTrate™ Blood Filtration system

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.

Intervention Type DEVICE

Saline

Normal (0.9%) saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Research Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bijan Modarai, PhD, FRCS

Role: STUDY_CHAIR

St Thomas' Hospital

Václav Procházka, MD, PhD, MSc

Role: STUDY_CHAIR

University Hospital Ostrava

Giulio Pompilio, MD, PhD

Role: STUDY_CHAIR

Centro Cardiologico Monzino IRCCS

Locations

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Manchester Royal Infirmary, Manchester Vascular Centre

Manchester, Great Britian, United Kingdom

Site Status

The Leeds Teaching Hospital NHS Trust

Leeds, West Yorkshire, United Kingdom

Site Status

St Thomas' Hospital

London, , United Kingdom

Site Status

Countries

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Czechia Poland United Kingdom

Other Identifiers

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15-03

Identifier Type: -

Identifier Source: org_study_id