NCT03809494

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

July 23, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2020

Completed
Last Updated

December 2, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

January 16, 2019

Last Update Submit

November 30, 2020

Conditions

Critical Limb IschemiaIschemia

Keywords

lower extremityPeripheral Arterial DiseaseIschemiaPeripheral Blood Stem Cell TransplantationLeukocytes, MononuclearTransplantation, Autologous

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Saline (Control Arm)

PLACEBO COMPARATOR

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

Other: Saline

Interventions

HemaTrate™ Blood Filtration systemDEVICE

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.

Treatment Arm
SalineOTHER

Normal (0.9%) saline

Saline (Control Arm)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Manchester Royal Infirmary, Manchester Vascular Centre

Manchester, Great Britian, M13 9WL, United Kingdom

Location

The Leeds Teaching Hospital NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaIschemiaPeripheral Arterial Disease

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 18, 2019

Study Start

July 23, 2019

Primary Completion

November 27, 2020

Study Completion

November 27, 2020

Last Updated

December 2, 2020

Record last verified: 2020-11

Locations

GB(3)