Back to resultsAssessment of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia
Primary Purpose
Critical Limb Ischemia
Status
Suspended
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Injections
Sponsored by
About this trial
This is an interventional treatment trial for Critical Limb Ischemia focused on measuring Cell therapy, Autologous
Eligibility Criteria
Inclusion Criteria:
- Patient is diagnosed with critical limb ischemia
- Patient has hemodynamic indicators of severe peripheral arterial disease
- Patient is not a candidate for revascularization treatment options for peripheral arterial disease
- Patient is on standard of care medical therapy for peripheral arterial disease
- Male or female age 18 and above
- Non-pregnant, non-lactating female
- Patient is able to understand and provide a signed informed consent form
Exclusion Criteria:
- Patient having an uncorrected Aorto-Iliac occlusive disease down to the origin of the Profunda-Femoris artery
- Patient who in the opinion of the investigator would require a major amputation within approximately 4 weeks after administration of study treatment.
- Critical Limb Ischemia presenting as severe large ischemic ulcers or dry gangrene proximal to the MTP (Metatarsophalangeal) joints heads or lower extremity wet gangrene
- Lower extremity non-treated active infection
- Hypercoagulable state
- Patient received blood transfusions during the previous 4 weeks
- Patient's condition precludes 2 consecutive attempts of ACPs manufacturing
- Patient unable to communicate
- Major non-vascular operation during the preceding 3 months
- Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure during the preceding 3 months
- Severe aortic stenosis
- Severe renal failure
- Severe hepatic failure
- Anemia
- Major stroke within the preceding 3 months.
- Diagnosis of malignancy within the preceding 3 years
- Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms
- Severe concurrent disease
- Bleeding diathesis.
- Participation at the same time in another stem cell study
- Chronic immunomodulating or cytotoxic drug treatment
- Fever for 2 days prior to the time the patient is about to receive the study treatment
- Life expectancy of less than 6 months
- Patient unlikely to be available for follow-up
- No acute worsening of CLI (Critical Limb Ischemia)
Sites / Locations
- Vancouver General Hospital
- Toronto General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Angiogenic Cell Precursors
Cell culture medium
Arm Description
Intra-muscular injections of Angiogenic Cell Precursors (ACPs) in the ischemic leg
Intra-muscular injections of cell culture medium in the ischemic leg
Outcomes
Primary Outcome Measures
Time to major amputation / mortality
Secondary Outcome Measures
Change from baseline in the level of pain in the treated ischemic leg
Change from baseline in the quantity of analgesic drugs used by the patient
Change from baseline in ABI (Ankle Brachial Index)
Change from baseline in TBI (Toe Brachial Index)
Change from baseline in quality of life
Change from baseline in ulcer size
Total hospitalization time of ACP-treated patients compared to controls
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02140931
Brief Title
Assessment of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia
Official Title
A Randomized Double Blind Placebo Controlled Clinical Study to Assess Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Suspended
Why Stopped
Duplicate listing
Study Start Date
August 2014 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hemostemix
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized, double-blind placebo controlled study to determine the safety and efficacy of Angiogenic Cell Precursors (ACPs) in relieving symptoms of Critical Limb Ischemia in patients treated with standard of care and with no surgical revascularization option. It is assumed that the ACP-treated group will have a lower amputation and death rate as compared to the placebo group. Other hemodynamic, imaging and clinical parameters will also be compared between the two groups. Quality of life assessments will also be performed.
Detailed Description
This prospective, randomized, double-blind, placebo controlled study will assess the efficacy and safety of autologous ACPs administered intramuscularly into the lower extremity of subjects with CLI who lack surgical or endovascular revascularization options.
A total of approximately 95 subjects will be randomized to treatment with ACP-01 or placebo using a 2:1 randomization scheme, respectively, stratified by site.
The study will continue until all subjects treated experience the study event (either de novo gangrene, doubling of wound size, major amputation, or death) or are event-free for at least 26 weeks. Subjects treated will be followed for no longer than 52 weeks.
One futility analysis for potentially stopping study enrollment will be performed.
Subjects treated at each investigative site will provide written informed consent prior to the conduct of any study-related procedures. Thereafter, they will be screened and those meeting the inclusion/exclusion criteria will be enrolled into the trial and undergo all the study procedures including intramuscular injection of the investigational medicinal product (IMP = ACP-01 or placebo). The IMP will be administered in addition to any conventional treatment the subject is receiving.
The control group will receive placebo injections into the lower extremity to ensure blinding of the assessors and the subjects.
The placebo will consist of the same medium used in the ACP product suspension.
The study consists of four periods: Screening period, Treatment period, Acute safety follow-up and Long term follow-up periods. The total duration of study participation, including follow-up, is at least 26 weeks. Subjects will be followed for up to 52 weeks and at least until the last subject has completed his/her 26 week visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia
Keywords
Cell therapy, Autologous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Angiogenic Cell Precursors
Arm Type
Active Comparator
Arm Description
Intra-muscular injections of Angiogenic Cell Precursors (ACPs) in the ischemic leg
Arm Title
Cell culture medium
Arm Type
Placebo Comparator
Arm Description
Intra-muscular injections of cell culture medium in the ischemic leg
Intervention Type
Drug
Intervention Name(s)
Injections
Intervention Description
Intra-muscular injections
Primary Outcome Measure Information:
Title
Time to major amputation / mortality
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the level of pain in the treated ischemic leg
Time Frame
26 weeks
Title
Change from baseline in the quantity of analgesic drugs used by the patient
Time Frame
26 weeks
Title
Change from baseline in ABI (Ankle Brachial Index)
Time Frame
26 weeks
Title
Change from baseline in TBI (Toe Brachial Index)
Time Frame
26 weeks
Title
Change from baseline in quality of life
Time Frame
26 weeks
Title
Change from baseline in ulcer size
Time Frame
26 weeks
Title
Total hospitalization time of ACP-treated patients compared to controls
Time Frame
26 weeks
Other Pre-specified Outcome Measures:
Title
Safety of intramuscular injection of ACPs
Description
Vital signs
Physical examination
Clinical laboratory values
Electrocardiograms
Adverse events
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is diagnosed with critical limb ischemia
Patient has hemodynamic indicators of severe peripheral arterial disease
Patient is not a candidate for revascularization treatment options for peripheral arterial disease
Patient is on standard of care medical therapy for peripheral arterial disease
Male or female age 18 and above
Non-pregnant, non-lactating female
Patient is able to understand and provide a signed informed consent form
Exclusion Criteria:
Patient having an uncorrected Aorto-Iliac occlusive disease down to the origin of the Profunda-Femoris artery
Patient who in the opinion of the investigator would require a major amputation within approximately 4 weeks after administration of study treatment.
Critical Limb Ischemia presenting as severe large ischemic ulcers or dry gangrene proximal to the MTP (Metatarsophalangeal) joints heads or lower extremity wet gangrene
Lower extremity non-treated active infection
Hypercoagulable state
Patient received blood transfusions during the previous 4 weeks
Patient's condition precludes 2 consecutive attempts of ACPs manufacturing
Patient unable to communicate
Major non-vascular operation during the preceding 3 months
Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure during the preceding 3 months
Severe aortic stenosis
Severe renal failure
Severe hepatic failure
Anemia
Major stroke within the preceding 3 months.
Diagnosis of malignancy within the preceding 3 years
Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms
Severe concurrent disease
Bleeding diathesis.
Participation at the same time in another stem cell study
Chronic immunomodulating or cytotoxic drug treatment
Fever for 2 days prior to the time the patient is about to receive the study treatment
Life expectancy of less than 6 months
Patient unlikely to be available for follow-up
No acute worsening of CLI (Critical Limb Ischemia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Jain, PhD
Organizational Affiliation
Hemostemix Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1K3
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.hemostemix.com/
Description
Hemostemix web site
Learn more about this trial
Assessment of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia
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