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
NCT ID: NCT03006770
Last Updated: 2024-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
213 participants
INTERVENTIONAL
2017-05-22
2022-04-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)
NCT00951210
Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia
NCT00919958
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
NCT00566657
Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)
NCT01679990
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
NCT03174522
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PLX-PAD
PLX-PAD will be administered via 30 IM injections (0.5 mL each). Each subject will be treated twice, with an interval of 8 weeks between treatments.
PLX-PAD
Local intramuscular (IM) injections of PLX-PAD in the index leg.
Placebo
Placebo will be administered via 30 IM injections (0.5 mL each). Each subject will be treated twice, with an interval of 8 weeks between treatments.
Placebo
Local intramuscular (IM) injections of Placebo in the index leg.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PLX-PAD
Local intramuscular (IM) injections of PLX-PAD in the index leg.
Placebo
Local intramuscular (IM) injections of Placebo in the index leg.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. CLI, with minor tissue loss up to the ankle level (Rutherford Category 5)
3. Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg. (If a subject has ABI \>1.4 and TP is not measureable, inclusion may be based on TcPO2 ≤30 mmHg)
4. Subject unsuitable for revascularization (by any method) in the index leg.
5. Ischemic lesions in the index leg stable for at least 2 weeks.
6. Ischemic ulcers in the index leg without tendon or bone exposure (unless secondary to a minor amputation).
7. Under treatment for cardiovascular risk factors: hypertension, hyperlipidemia, diabetes, in accordance with applicable guidelines. Concomitant therapy with a statin and an anti-platelet agent for at least 2 weeks prior to randomization.
8. Women of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use at least one highly effective birth control method throughout the study.
9. Subject understood, agreed and provided informed consent. Patients must give written informed consent before any assessment is performed .
Exclusion Criteria
2. CLI with major tissue loss (Rutherford Category 6) in either leg.
3. Evidence of active infection (e.g., cellulitis, osteomyelitis).
4. Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks prior to screening.
5. Planned or potential need for major/minor amputation or any revascularization within 1 month of study entry upon investigator's judgment.
6. Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise suspicion of inadequate inflow to the leg.
7. Life expectancy of less than 6 months.
8. Stroke or acute myocardial infarction/unstable angina within 3 months prior to screening.
9. Severe congestive heart failure symptoms (New York Heart Association \[NYHA\] class III-IV).
10. Uncontrolled severe hypertension.
11. Diabetes mellitus with HbA1c \>10%.
12. Current or history of proliferative retinopathy.
13. Known Hepatitis B virus or Hepatitis C virus or acquired immunodeficiency syndrome (AIDS) infections.
14. Subjects with international normalized ratio (INR) \>2.
15. Subject on renal replacement therapy or planned to start renal replacement therapy within 3 months of first screening visit.
16. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending another investigational device or drug trial(s), unless in long-term follow-up phase.
17. Use of hyperbaric oxygen therapy, prostanoids, spinal cord stimulation, lumbar sympathectomy, wound dressing containing cells or growth factors, or topical platelet derived growth factor.
18. Known allergies to any of the following: DMSO, human serum albumin, bovine serum albumin.
19. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine.
20. Pulmonary disease requiring supplemental oxygen treatment on a daily basis.
21. Active malignancy or history of malignancy within 5 years prior to study entry.
22. In the opinion of the investigator, the subject is unsuitable for participating in the study.
23. Chronic liver disease Child Pugh class B\\C
45 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pluristem Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCI Medical Center 101 The City Drive S. Bldg 55 Rm 334 Orange, CA 92868
Irvine, California, United States
Cedars Sinai Medical Center,LA,Beverly Hills,8536 Wilshire Boulevard, Third Floor
Los Angeles, California, United States
Vascular Center ∣ Department of Surgery ∣ UC Davis Health 4860 Y street, Sacramento, CA suite #3400, 95817
Sacramento, California, United States
Vascular Center,Department of Surgery,UC Davis Health,4860 Y street
Sacramento, California, United States
University of Miami Leonard M.Miller School of Medicine (UMMSM)-UHealth Pulmonary and Critical Care Medicine-Rosenstiel Building Location
Miami, Florida, United States
Miami Cardiac and Vascular Institute Baptist Health South Florida
Miami, Florida, United States
Tufts Medical Center (TMC) (Tufts-New England Medical Center)
Boston, Massachusetts, United States
Room S3-746, Dept of Surgery, UMASS Medical School, 55 Lake Ave North.
Worcester, Massachusetts, United States
Holy Medical Center
Teaneck, New Jersey, United States
Northwell Health Comprehensive Wound Healing Center
Lake Success, New York, United States
Mount Sinai St. Luke's hospital
New York, New York, United States
Duke University Medical Center,Durham,2424 Erwin Road Hock Plaza
Durham, North Carolina, United States
Austin Heart Clinical Research
Austin, Texas, United States
Department of Plastic Surgery ,Ut Southwestern Medical Center
Dallas, Texas, United States
UMHAT "Virgin Mary" EOOD,Clinic of Vascular Surgery
Burgas, , Bulgaria
MHAT Sveti Nokolay Chudotvorets EOOD - Lom,Surgery Department,Address 2, Todor Kableshkov str.
Lom, , Bulgaria
UMHAT "St. Georgi" EAD,Clinic: Vascular Surgery and Angiology 66 "Peshtersko Shosse" Blvd., 8th floor, Hirurgicheski blok
Plovdiv, , Bulgaria
UMBAL Kanev AD - Ruse,Department of Vascular Surgery Address: 2, Nezavisimost str
Rousse, , Bulgaria
UMHAT "Medica" Ruse Department of Vascular Surgery 35, "Riga", Str Post code: 7013 Ruse, Bulgaria
Rousse, , Bulgaria
MHAT National Heart Hospital EAD,Clinic of Vascular Surgery and angiology
Sofia, , Bulgaria
Acibadem City Clinic MHAT Tokuda, Vascular Surgery and Angiology 51B "Nikola Vaptzarov" Blvd
Sofia, , Bulgaria
UMHAT "St. Ekaterina" EAD, Departement of Vascular Surgery
Sofia, , Bulgaria
Cevni ambulance
Hodonín, , Czechia
Angiologicka ambulance
Ostrava Dubina, , Czechia
Vseobecna Fakultni Nemocnice v Praze
Prague, , Czechia
Intitute of Clinical and Experimental Medicine
Prague, , Czechia
Krajska zdravotni a.s., Masarykova nemocnice o.z.
Ústí nad Labem, , Czechia
Klinik und Poliklinik für Angiologie Universitätsklinikum Leipzig AöR Liebigstr. 20 04103 Leipzig, Germany
Leipzig, Saxony, Germany
Medinos Klinikum Sonneberg Abteilung für Kardiologie/Angiologie - Studienambulanz Neustadter Straße 61 96515 Sonneberg Germany
Sonneberg, Thuringia, Germany
Universitats-Herzzentrum Freiburg
Bad Krozingen, , Germany
Charite Centrum fur Herz - Kreislauf - und Gefassmedizin - Campus Benjamin Franklin
Berlin, , Germany
HELIOS Klinikum Berlin-Buch, Klinik fur Angiologie
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)
Düsseldorf, , Germany
Asklepios Klinik St.Georg-Angiologische Ambulanz
Hamburg, , Germany
Klinik Kösching Krankenhausstr. 19, 85092 Kösching Germany
Kösching, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Fejér, Hungary
Szent Imre Egyetemi Oktato Korhaz
Budapest, , Hungary
Flor Ferenc County Hospital
Kistarcsa, , Hungary
B-A-Z County and University Teaching Hospital
Miskolc, , Hungary
Josa Andras Megyei Korhaz
Nyíregyháza, , Hungary
Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School)
Pécs, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Blood Vessel Day Care at Clalit Community Horev Center, Horev Center
Haifa, , Israel
Vascular Surgery Department, Hadassah Ein Karem MC
Jerusalem, , Israel
Vascular Surgery Department Rabin Medical Center Beilinson Hospital, 39 Jabotinski St. Petah Tikva Israel 4941492
Petah Tikva, , Israel
The Cardiological Department, The Baruch Padeh Medical Center
Poria Illit, , Israel
Acibadem Sistina Hospital,Thoracic and Vascular Surgery
Skopje, , North Macedonia
Re-Medika General Hospital,Cardiovascular Surgery
Skopje, , North Macedonia
Special Hospital for Surgical Diseases Zan Mitrev Clinic ,Cardiovascular Surgery
Skopje, , North Macedonia
Cathedra and Clinic of Vascular Surgery and Angiology-Klinika Chirurgii Naczyniowej i Angiologii
Lublin, , Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu, Osrodek Badawczo-Rozwojowy,Intensywnego Nadzoru Kardlologleznego,
Wroclaw, , Poland
Vascular Research Clinical Research Centre Beaufort Way Southmead Hospital Westbury on Trym Bristol
Bristol, , United Kingdom
Hull And East Yorkshire Women And Children's Hospital-Hull And East Yorkshire Hospitals Nhs Trust
Hull, , United Kingdom
Kings College Hospital
London, , United Kingdom
Department of Vascular Research, St George's Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Norgren L, Weiss N, Nikol S, Lantis JC, Patel MR, Hinchliffe RJ, Reinecke H, Volk HD, Reinke P, Fadini GP, Ofir R, Rothenstein D, Halevy N, Karagjozov M, Rundback JH. PACE: randomized, controlled, multicentre, multinational, phase III study of PLX-PAD for critical limb ischaemia in patients unsuitable for revascularization: randomized clinical trial. Br J Surg. 2024 Jan 31;111(2):znad437. doi: 10.1093/bjs/znad437.
Norgren L, Weiss N, Nikol S, Hinchliffe RJ, Lantis JC, Patel MR, Reinecke H, Ofir R, Rosen Y, Peres D, Aberman Z. PLX-PAD Cell Treatment of Critical Limb Ischaemia: Rationale and Design of the PACE Trial. Eur J Vasc Endovasc Surg. 2019 Apr;57(4):538-545. doi: 10.1016/j.ejvs.2018.11.008. Epub 2019 Jan 25.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PLX-CLI-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.