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

PHASE3CompletedINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

May 22, 2017

Primary Completion Date

March 3, 2021

Study Completion Date

April 20, 2022

Conditions
Critical Limb Ischemia (CLI)
Interventions
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.

Trial Locations (57)

1000

Acibadem Sistina Hospital,Thoracic and Vascular Surgery, Skopje

Re-Medika General Hospital,Cardiovascular Surgery, Skopje

Special Hospital for Surgical Diseases Zan Mitrev Clinic ,Cardiovascular Surgery, Skopje

1115

Szent Imre Egyetemi Oktato Korhaz, Budapest

1309

MHAT National Heart Hospital EAD,Clinic of Vascular Surgery and angiology, Sofia

1407

"Acibadem City Clinic MHAT Tokuda, Vascular Surgery and Angiology 51B Nikola Vaptzarov Blvd", Sofia

1431

"UMHAT St. Ekaterina EAD, Departement of Vascular Surgery", Sofia

2143

Flor Ferenc County Hospital, Kistarcsa

3526

B-A-Z County and University Teaching Hospital, Miskolc

3600

MHAT Sveti Nokolay Chudotvorets EOOD - Lom,Surgery Department,Address 2, Todor Kableshkov str., Lom

4001

"UMHAT St. Georgi EAD,Clinic: Vascular Surgery and Angiology 66 Peshtersko Shosse Blvd., 8th floor, Hirurgicheski blok", Plovdiv

4400

Josa Andras Megyei Korhaz, Nyíregyháza

7002

UMBAL Kanev AD - Ruse,Department of Vascular Surgery Address: 2, Nezavisimost str, Rousse

7013

"UMHAT Medica Ruse Department of Vascular Surgery 35, Riga, Str Post code: 7013 Ruse, Bulgaria", Rousse

7624

Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School), Pécs

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8127

"UMHAT Virgin Mary EOOD,Clinic of Vascular Surgery", Burgas

11042

Northwell Health Comprehensive Wound Healing Center, Lake Success

12203

Charite Centrum fur Herz - Kreislauf - und Gefassmedizin - Campus Benjamin Franklin, Berlin

12802

Vseobecna Fakultni Nemocnice v Praze, Prague

13125

HELIOS Klinikum Berlin-Buch, Klinik fur Angiologie, Berlin

15208

The Cardiological Department, The Baruch Padeh Medical Center, Poria Illit

20099

Asklepios Klinik St.Georg-Angiologische Ambulanz, Hamburg

27710

Duke University Medical Center,Durham,2424 Erwin Road Hock Plaza, Durham

33176

Miami Cardiac and Vascular Institute Baptist Health South Florida, Miami

40113

Krajska zdravotni a.s., Masarykova nemocnice o.z., Ústí nad Labem

40225

Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD), Düsseldorf

48155

Universitaetsklinikum Muenster, Münster

69501

Cevni ambulance, Hodonín

78100

Barzilai Medical Center, Ashkelon

78756

Austin Heart Clinical Research, Austin

79189

Universitats-Herzzentrum Freiburg, Bad Krozingen

85092

Klinik Kösching Krankenhausstr. 19, 85092 Kösching Germany, Kösching

90211

Cedars Sinai Medical Center,LA,Beverly Hills,8536 Wilshire Boulevard, Third Floor, Los Angeles

91120

Vascular Surgery Department, Hadassah Ein Karem MC, Jerusalem

92697

UCI Medical Center 101 The City Drive S. Bldg 55 Rm 334 Orange, CA 92868, Irvine

95817

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

96515

Medinos Klinikum Sonneberg Abteilung für Kardiologie/Angiologie - Studienambulanz Neustadter Straße 61 96515 Sonneberg Germany, Sonneberg

3434119

Blood Vessel Day Care at Clalit Community Horev Center, Horev Center, Haifa

4941492

Vascular Surgery Department Rabin Medical Center Beilinson Hospital, 39 Jabotinski St. Petah Tikva Israel 4941492, Petah Tikva

33136-1015

University of Miami Leonard M.Miller School of Medicine (UMMSM)-UHealth Pulmonary and Critical Care Medicine-Rosenstiel Building Location, Miami

02111-1552

Tufts Medical Center (TMC) (Tufts-New England Medical Center), Boston

01655

Room S3-746, Dept of Surgery, UMASS Medical School, 55 Lake Ave North., Worcester

07666

Holy Medical Center, Teaneck

10019-1147

Mount Sinai St. Luke's hospital, New York

75390-9132

Department of Plastic Surgery ,Ut Southwestern Medical Center, Dallas

700 30

Angiologicka ambulance, Ostrava Dubina

140 21

Intitute of Clinical and Experimental Medicine, Prague

04103

Klinik und Poliklinik für Angiologie Universitätsklinikum Leipzig AöR Liebigstr. 20 04103 Leipzig, Germany, Leipzig

Unknown

Universitätsklinikum Carl Gustav Carus, Dresden

20-081

Cathedra and Clinic of Vascular Surgery and Angiology-Klinika Chirurgii Naczyniowej i Angiologii, Lublin

51-124

Wojewodzki Szpital Specjalistyczny we Wroclawiu, Osrodek Badawczo-Rozwojowy,Intensywnego Nadzoru Kardlologleznego,, Wroclaw

BS10 5NB

Vascular Research Clinical Research Centre Beaufort Way Southmead Hospital Westbury on Trym Bristol, Bristol

HU32JZ

Hull And East Yorkshire Women And Children's Hospital-Hull And East Yorkshire Hospitals Nhs Trust, Hull

SE5 9RS

Kings College Hospital, London

SW17 0QT

Department of Vascular Research, St George's Hospital, London

All Listed Sponsors
lead

Pluristem Ltd.

INDUSTRY

NCT03006770 - 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 | Biotech Hunter | Biotech Hunter