HemaTrate™ in the Treatment of Critical Limb Ischemia

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

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.

Study Overview

• Status: Terminated
• Conditions: Ischemia; Critical Limb Ischemia
• Intervention / Treatment: Device: HemaTrate™ Blood Filtration system; Other: Saline

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • St Thomas' Hospital
  • Great Britian
    • Manchester, Great Britian, United Kingdom, M13 9WL
      • Manchester Royal Infirmary, Manchester Vascular Centre
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • The Leeds Teaching Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 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; 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.
Placebo Comparator: Saline (Control Arm); Patients assigned to the control arm will be injected with saline three times at six week intervals.	Other: Saline; Normal (0.9%) saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cook Research Incorporated
• Investigators: Study Chair: Bijan Modarai, PhD, FRCS, St Thomas' Hospital; Study Chair: Václav Procházka, MD, PhD, MSc, University Hospital Ostrava; Study Chair: Giulio Pompilio, MD, PhD, Centro Cardiologico Monzino IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Actual): November 27, 2020
• Study Completion (Actual): November 27, 2020

Study Registration Dates

• First Submitted: January 16, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Ischemia; lower extremity; Peripheral Arterial Disease; Peripheral Blood Stem Cell Transplantation; Leukocytes, Mononuclear; Transplantation, Autologous
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: 15-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No