Assessment of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia
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| ClinicalTrials.gov Identifier: NCT02140931 |
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Recruitment Status :
Enrolling by invitation
First Posted : May 16, 2014
Last Update Posted : July 26, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Critical Limb Ischemia | Drug: Injections | Phase 2 |
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 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-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia |
| Actual Study Start Date : | August 2014 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | July 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Angiogenic Cell Precursors
Intra-muscular injections of Angiogenic Cell Precursors (ACPs) in the ischemic leg
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Drug: Injections
Intra-muscular injections |
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Placebo Comparator: Cell culture medium
Intra-muscular injections of cell culture medium in the ischemic leg
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Drug: Injections
Intra-muscular injections |
- Time to major amputation / mortality [ Time Frame: 26 weeks ]
- 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 ]
- Safety of intramuscular injection of ACPs [ Time Frame: 26 weeks ]
- Vital signs
- Physical examination
- Clinical laboratory values
- Electrocardiograms
- Adverse events
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, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
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
| Canada, British Columbia | |
| Vancouver General Hospital | |
| Vancouver, British Columbia, Canada, V5Z 1K3 | |
| Canada, Ontario | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Study Director: | Ravi Jain, PhD | Hemostemix Inc. |
Additional Information:
| Responsible Party: | Hemostemix |
| ClinicalTrials.gov Identifier: | NCT02140931 History of Changes |
| Other Study ID Numbers: |
HS 12-01 |
| First Posted: | May 16, 2014 Key Record Dates |
| Last Update Posted: | July 26, 2018 |
| Last Verified: | July 2018 |
Keywords provided by Hemostemix:
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Cell therapy Autologous |
Additional relevant MeSH terms:
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Ischemia Pathologic Processes |