Critical Limb IschemiaPhase 2NCT02551679
ACP-01 in Patients With Critical Limb Ischemia
A Phase 2 study testing ACP-01 in people with Critical Limb Ischemia, run by Hemostemix at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- ACP-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Aug 2014to Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 23Show fewer
- 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.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States16 sites
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
Medical University of South Carolina
Charleston, South Carolina, 29425
Decatur Memorial Hospital
Decatur, Illinois, 62526
University of Florida
Gainesville, Florida, 32610
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
Houston Methodist DeBakey Heart & Vascular Center
Houston, Texas, 77030
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire
Loyola University Medical Center
Maywood, Illinois, 60153
Clinovation Research, LLC
Miami, Florida, 33126
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Temple University Hosptial
Philadelphia, Pennsylvania, 19140
UC Davis CTSC Clinical Research Center
Sacramento, California, 95817
Clinical Trials of Texas, Inc. (CTT)
San Antonio, Texas, 78229
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Clinical Research of Central Florida
Winter Haven, Florida, 33880
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Canada3 sites
London Health Sciences Centre
London, Ontario, N6A 5W9
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1K3
About this study
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)
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.
Read the 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.
- Conditions
- Critical Limb Ischemia
- Being tested
- ACP-01, Placebo
- Keywords
- Stem cells, Autologous, Vascular disease, Peripheral arterial disease, Regenerative medicine, Amputation
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-01Biological
Injection into lower extremity
PlaceboBiological
Injection into lower extremity
| Study group | Role | What they receive |
|---|---|---|
| ACP-01 | Active comparator | Injection into lower extremity Receives: Biological: ACP-01 |
| Placebo | Placebo comparator | Injection into lower extremity Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Size, Amputation or Survival
Number of subject with doubling of wound size, major amputation or death
Measured: Baseline vs. 1 year
Secondary outcomes (2)
Pain Level
Change in pain score according to the Visual Analog Scale (VAS) for Pain. The visual VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the subjects' marks are recorded in centimeters and are interpreted as their pain. The values ar used to track pain progression for a subject and to compare pain between subjects.
Measured: Baseline vs. 1 year
Ulcer Size
Change in ulcer size
Measured: Baseline vs. 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startAug 2014
- Primary completionApr 2020
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hemostemix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551679
- Sponsor's protocol ID
- HS 12-01.
- Status last verified
- Nov 2023
- First submitted
- 14 Sep 2015
- Last updated
- 28 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02551679
- Acronym / sponsor ID
- HS 12-01.
- Conditions
- Critical Limb Ischemia
- Keywords
- Stem cells, Autologous, Vascular disease, Peripheral arterial disease, Regenerative medicine, Amputation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- HemostemixIndustry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACP-01 | Active comparator | Biological: ACP-01Injection into lower extremity |
| Placebo | Placebo comparator | Biological: PlaceboInjection into lower extremity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP-01Injection into lower extremity | Biological | ACP-01 |
| PlaceboInjection into lower extremity | Biological | Placebo |
Primary outcome
Wound Size, Amputation or Survival
Time frame: Baseline vs. 1 year
Number of subject with doubling of wound size, major amputation or death
2 secondary outcomes
Pain Level
Time frame: Baseline vs. 1 year
Ulcer Size
Time frame: Baseline vs. 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hemostemix Inc. websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACP-01 in people with Critical Limb Ischemia, run by Hemostemix at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Size, Amputation or Survival (time frame: Baseline vs. 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.