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Trial record 1 of 1 for:    NCT02140931
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Assessment of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Hemostemix.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02140931
First Posted: May 16, 2014
Last Update Posted: September 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hemostemix
  Purpose
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.

Condition Intervention Phase
Critical Limb Ischemia Procedure: Injections Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Hemostemix:

Primary Outcome Measures:
  • Time to major amputation / mortality [ Time Frame: 26 weeks ]

Secondary Outcome Measures:
  • Change from baseline in the level of pain in the treated ischemic leg [ Time Frame: 26 weeks ]
  • Change from baseline in the quantity of analgesic drugs used by the patient [ Time Frame: 26 weeks ]
  • Change from baseline in ABI (Ankle Brachial Index) [ Time Frame: 26 weeks ]
  • Change from baseline in TBI (Toe Brachial Index) [ Time Frame: 26 weeks ]
  • Change from baseline in quality of life [ Time Frame: 26 weeks ]
  • Change from baseline in ulcer size [ Time Frame: 26 weeks ]
  • Total hospitalization time of ACP-treated patients compared to controls [ Time Frame: 26 weeks ]

Other Outcome Measures:
  • Safety of intramuscular injection of ACPs [ Time Frame: 26 weeks ]
    • Vital signs
    • Physical examination
    • Clinical laboratory values
    • Electrocardiograms
    • Adverse events


Estimated Enrollment: 95
Study Start Date: August 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Angiogenic Cell Precursors
Intra-muscular injections of Angiogenic Cell Precursors (ACPs) in the ischemic leg
Procedure: Injections
Intra-muscular injections
Placebo Comparator: Cell culture medium
Intra-muscular injections of cell culture medium in the ischemic leg
Procedure: Injections
Intra-muscular injections

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140931


Contacts
Contact: Robert J Bard, JD, RAC, CQE 248-573-5040 bbard@hemostemix.com
Contact: Hardean E Achneck, MD 617-500-8372 HAchneck@Hemostemix.com

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1K3
Contact: York N. Hsiang, MB ChB MHSc    604.876.5882    york.hsiang@vch.ca   
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Thomas F. Lindsy, MDCM Msc BSc    416.340.4800 ext 4620    thomas.lindsay@uhn.on.ca   
Sponsors and Collaborators
Hemostemix
Investigators
Study Director: Hardean E Achneck, M.D. Hemostemix Inc.
  More Information

Additional Information:
Responsible Party: Hemostemix
ClinicalTrials.gov Identifier: NCT02140931     History of Changes
Other Study ID Numbers: HS 12-01
First Submitted: May 14, 2014
First Posted: May 16, 2014
Last Update Posted: September 16, 2015
Last Verified: September 2015

Keywords provided by Hemostemix:
Cell therapy
Autologous

Additional relevant MeSH terms:
Ischemia
Pathologic Processes