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ACP-01 in Patients With Critical Limb Ischemia

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02551679
Recruitment Status : Recruiting
First Posted : September 16, 2015
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hemostemix

Brief Summary:
The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of care therapy and have no endovascular or surgical revascularization options.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Biological: ACP-01 Biological: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
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-Derived Autologous Angiogenic Cell Precursor Therapy in Patients With Critical Limb Ischemia (ACP-CLI)
Actual Study Start Date : August 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: ACP-01
Injection into lower extremity
Biological: ACP-01
Injection into lower extremity

Placebo Comparator: Placebo
Injection into lower extremity
Biological: Placebo
Injection into lower extremity




Primary Outcome Measures :
  1. Wound Size, Amputation or Survival [ Time Frame: 1 year ]
    Time to doubling of wound size, major amputation or death


Secondary Outcome Measures :
  1. Pain Level [ Time Frame: 1 year ]
    Change in pain score according to the Visual Analog Scale for Pain.

  2. Ulcer Size [ Time Frame: 1 year ]
    Change in ulcer size


Other Outcome Measures:
  1. Change from baseline in the dose and quantity of analgesic drugs used by the subject [ Time Frame: 1 - 52 wks ]
  2. Reduction in total hospitalization time of subjects treated with ACP-01 compared to subjects treated with placebo [ Time Frame: 1 - 52 wks ]
  3. Change from Baseline in Quality of Life [ Time Frame: 1 - 52 wks ]
    Change in quality of life according to the Vascular Quality of Life Questionnaire.

  4. Change from Baseline in Ankle Pressure [ Time Frame: 1 - 52 wks ]
  5. Change from Baseline in Toe Pressure [ Time Frame: 1 - 52 wks ]


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is diagnosed with critical limb ischemia.
  • Subject has hemodynamic indicators of severe peripheral arterial occlusive disease.
  • Subject is not a candidate for standard revascularization treatment options for peripheral arterial disease.
  • Subject must be on standard of care medical therapy for peripheral vascular disease.
  • Male or female age 18 and above.
  • Non-pregnant, non-lactating female.
  • Subject is able to understand and provide voluntary signed informed consent.

Exclusion Criteria:

  • Uncorrected aorto-iliac occlusive disease.
  • Subjects who, in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation in a time frame shortly after administration of the IMP (investigational drug or placebo).
  • Advanced Critical Limb Ischemia (CLI) presenting as severe ischemic or dry gangrene.
  • Lower extremity non-treated active infection.
  • Hypercoagulable state.
  • Subject received a blood transfusion during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
  • Inability to communicate that may interfere with clinical evaluation.
  • Recent major non-vascular operation.
  • Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure.
  • Severe aortic stenosis.
  • Renal failure.
  • Hepatic failure.
  • Anemia.
  • Major stroke.
  • Diagnosis of malignancy.
  • Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms.
  • Severe concurrent disease (other than Peripheral Vascular Disease (PAD)).
  • Bleeding diathesis.
  • Participation at the same time in another investigational product or device study.
  • Chronic cytotoxic drug treatment.
  • Life expectancy of less than 6 months.
  • Subject unlikely to be available for follow-up.
  • Acute worsening of CLI.

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): NCT02551679


Contacts
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Contact: Alan Jacobs, MSEE MD PhD regulatory@aspire2cure.com

Locations
Show Show 21 study locations
Sponsors and Collaborators
Hemostemix

Additional Information:
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Responsible Party: Hemostemix
ClinicalTrials.gov Identifier: NCT02551679    
Other Study ID Numbers: HS 12-01.
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Keywords provided by Hemostemix:
Stem cells
Autologous
Vascular disease
Peripheral arterial disease
Regenerative medicine
Amputation
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes