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NCT03006770 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Critical Limb Ischemia (CLI), sponsored by Pluristem.
- Completed
- Registry status
- Phase 3
- Development phase
- 213
- Enrollment target
- 20
- Study locations
NCT03006770: Completed Phase 3 study of Critical Limb Ischemia (CLI), sponsored by Pluristem.
NCT03006770 is a Phase 3 study of Critical Limb Ischemia (CLI) that has completed, run by Pluristem. The registered enrollment target is 213 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03006770, a Phase 3 study of Critical Limb Ischemia (CLI), has completed, sponsored by Pluristem.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 213 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL PLX-PAD
Study Locations (20)
Other
- UMHAT "Virgin Mary" EOOD,Clinic of Vascular Surgery - Burgas
- MHAT Sveti Nokolay Chudotvorets EOOD - Lom,Surgery Department,Address 2, Todor Kableshkov str. - Lom
- UMHAT "St. Georgi" EAD,Clinic: Vascular Surgery and Angiology 66 "Peshtersko Shosse" Blvd., 8th floor, Hirurgicheski blok - Plovdiv
- UMBAL Kanev AD - Ruse,Department of Vascular Surgery Address: 2, Nezavisimost str - Rousse
- UMHAT "Medica" Ruse Department of Vascular Surgery 35, "Riga", Str Post code: 7013 Ruse, Bulgaria - Rousse
- MHAT National Heart Hospital EAD,Clinic of Vascular Surgery and angiology - Sofia
California
- UCI Medical Center 101 The City Drive S. Bldg 55 Rm 334 Orange, CA 92868 - Irvine
- Cedars Sinai Medical Center,LA,Beverly Hills,8536 Wilshire Boulevard, Third Floor - Los Angeles
- Vascular Center ∣ Department of Surgery ∣ UC Davis Health 4860 Y street, Sacramento, CA suite #3400, 95817 - Sacramento
- Vascular Center,Department of Surgery,UC Davis Health,4860 Y street - Sacramento
Florida
- University of Miami Leonard M.Miller School of Medicine (UMMSM)-UHealth Pulmonary and Critical Care Medicine-Rosenstiel Building Location - Miami
- Miami Cardiac and Vascular Institute Baptist Health South Florida - Miami
Massachusetts
- Tufts Medical Center (TMC) (Tufts-New England Medical Center) - Boston
- Room S3-746, Dept of Surgery, UMASS Medical School, 55 Lake Ave North. - Worcester
New York
- Northwell Health Comprehensive Wound Healing Center - Lake Success
- Mount Sinai St. Luke's hospital - New York
Texas
- Austin Heart Clinical Research - Austin
- Department of Plastic Surgery ,Ut Southwestern Medical Center - Dallas
New Jersey
- Holy Medical Center - Teaneck
North Carolina
- Duke University Medical Center,Durham,2424 Erwin Road Hock Plaza - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2017-05-22 |
| Est. Completion | 2022-04-20 |
| Phase | Phase 3 |
What the finished NCT03006770 record still lists
NCT03006770 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Critical Limb Ischemia (CLI) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03006770 names 20 study sites across 8 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03006770 about?
NCT03006770 is a clinical study titled "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". 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 Categ...
What is the current status of trial NCT03006770?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 213 participants. The study started on 2017-05-22. Estimated completion is 2022-04-20.
What conditions does trial NCT03006770 study?
This clinical trial studies the following conditions: Critical Limb Ischemia (CLI).
What interventions are being tested in trial NCT03006770?
The interventions under investigation include: Placebo (BIOLOGICAL), PLX-PAD (BIOLOGICAL).
Who is sponsoring clinical trial NCT03006770?
This trial is sponsored by Pluristem, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03006770 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03006770's enrollment target sits among peer trials
213 1335th of 2000 higher than 666 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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