Back to resultsHemaTrate™ in the Treatment of Critical Limb Ischemia
Primary Purpose
Critical Limb Ischemia, Ischemia
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HemaTrate™ Blood Filtration system
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Critical Limb Ischemia focused on measuring lower extremity, Peripheral Arterial Disease, Ischemia, Peripheral Blood Stem Cell Transplantation, Leukocytes, Mononuclear, Transplantation, Autologous
Eligibility Criteria
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
Sites / Locations
- Manchester Royal Infirmary, Manchester Vascular Centre
- The Leeds Teaching Hospital NHS Trust
- St Thomas' Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Arm
Saline (Control Arm)
Arm Description
Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals.
Patients assigned to the control arm will be injected with saline three times at six week intervals.
Outcomes
Primary Outcome Measures
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
Freedom from major amputation of the study leg
Percent of patients that have any amputation above the ankle of the study leg
Death
Percent of patients that exit due to death
Secondary Outcome Measures
Full Information
NCT ID
NCT03809494
First Posted
January 16, 2019
Last Updated
November 30, 2020
Sponsor
Cook Research Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT03809494
Brief Title
HemaTrate™ in the Treatment of Critical Limb Ischemia
Official Title
Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
The study has stopped early due to enrollment challenges related largely to the current pandemic
Study Start Date
July 23, 2019 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
November 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Research Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia, Ischemia
Keywords
lower extremity, Peripheral Arterial Disease, Ischemia, Peripheral Blood Stem Cell Transplantation, Leukocytes, Mononuclear, Transplantation, Autologous
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals.
Arm Title
Saline (Control Arm)
Arm Type
Placebo Comparator
Arm Description
Patients assigned to the control arm will be injected with saline three times at six week intervals.
Intervention Type
Device
Intervention Name(s)
HemaTrate™ Blood Filtration system
Intervention Description
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
Other
Intervention Name(s)
Saline
Intervention Description
Normal (0.9%) saline
Primary Outcome Measure Information:
Title
Freedom from vascular or endovascular arterial intervention below the knee of the study leg
Description
Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg
Time Frame
12 months
Title
Freedom from major amputation of the study leg
Description
Percent of patients that have any amputation above the ankle of the study leg
Time Frame
12 months
Title
Death
Description
Percent of patients that exit due to death
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bijan Modarai, PhD, FRCS
Organizational Affiliation
St Thomas' Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Václav Procházka, MD, PhD, MSc
Organizational Affiliation
University Hospital Ostrava
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Giulio Pompilio, MD, PhD
Organizational Affiliation
Centro Cardiologico Monzino IRCCS
Official's Role
Study Chair
Facility Information:
Facility Name
Manchester Royal Infirmary, Manchester Vascular Centre
City
Manchester
State/Province
Great Britian
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
The Leeds Teaching Hospital NHS Trust
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
HemaTrate™ in the Treatment of Critical Limb Ischemia
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