At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 67 enrolled
Drug / intervention
ACP-01 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating ACP-01 and Placebo for Critical Limb Ischemia. Completed, enrolled 67 participants across 19 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartAug 2014
First PostedSep 2015
Primary CompletionApr 2020
Study CompletionApr 2021
TodayJul 2026
First PostedSep 16, 2015
Enrollment StartAug 1, 2014
Primary CompletionApr 1, 2020
Study CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 10.8 years ago
Interventions
ACP-01biological
Injection into lower extremity
Placebobiological
Injection into lower extremity