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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
NCT03006770 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03006770
The ClinicalTrials.gov registry entry for NCT03006770 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 213 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pluristem, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03006770 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03006770?
The interventions under investigation include: Placebo (BIOLOGICAL), PLX-PAD (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03006770?
This trial is sponsored by Pluristem, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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