Trials / Completed
CompletedNCT03006770
Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 213 (actual)
- Sponsor
- Pluristem Ltd. · Industry
- Sex
- All
- Age
- 45 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with Minor Tissue Loss (Rutherford Category 5) who are Unsuitable for Revascularization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PLX-PAD | Local intramuscular (IM) injections of PLX-PAD in the index leg. |
| BIOLOGICAL | Placebo | Local intramuscular (IM) injections of Placebo in the index leg. |
Timeline
- Start date
- 2017-05-22
- Primary completion
- 2021-03-03
- Completion
- 2022-04-20
- First posted
- 2016-12-30
- Last updated
- 2024-08-30
Locations
57 sites across 9 countries: United States, Bulgaria, Czechia, Germany, Hungary, Israel, North Macedonia, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03006770. Inclusion in this directory is not an endorsement.