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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03006770
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : November 15, 2019
Information provided by (Responsible Party):
Pluristem Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia (CLI) Biological: PLX-PAD Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: 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.
Biological: PLX-PAD
Local intramuscular (IM) injections of PLX-PAD in the index leg.

Placebo Comparator: 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.
Biological: Placebo
Local intramuscular (IM) injections of Placebo in the index leg.

Primary Outcome Measures :
  1. Time to major amputation or death (AFS) [ Time Frame: Up to 36 months from enrollment ]

Secondary Outcome Measures :
  1. Time to first occurrence of any of the events (in index leg)-major amputation,revascularization due to worsening of CLI,doubling of total wound area from baseline,anew gangrene. All-cause mortality. [ Time Frame: Up to 36 months from enrollment ]
  2. Time to major amputation of the index leg. [ Time Frame: Up to 36 months from enrollment ]
  3. Complete wound healing in the index leg [ Time Frame: 12 months from enrollment ]
  4. Ischemic pain (NRS). [ Time Frame: 6 months from enrollment ]
  5. Time to adjudicated major amputation of the index leg or death [ Time Frame: Up to 36 months from enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adult male or female subjects between ages 45-99 years of age.
  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. Signed informed consent form.

Exclusion Criteria:

  1. Non-atherosclerotic PAD (e.g. Buerger's disease).
  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] Stage 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) >2.5.
  15. Subject on renal replacement therapy or with eGFR <15 mL/min/1.73m2.
  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. Inability to understand and provide an informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03006770

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United States, California
UCI Medical Center 101 The City Drive S. Bldg 55 Rm 334 Orange, CA 92868 Recruiting
Irvine, California, United States, 92697
Contact: Julie Nguyen    714-456-5431   
Contact: Trisha Maris   
Principal Investigator: Isabella Kuo, Dr.         
Cedars Sinai Medical Center,LA,Beverly Hills,8536 Wilshire Boulevard, Third Floor Recruiting
Los Angeles, California, United States, 90211
Contact: Suhail Dohad, Dr    310-248-8245   
Principal Investigator: Suhail Dohad, Dr         
Vascular Center ∣ Department of Surgery ∣ UC Davis Health 4860 Y street, Sacramento, CA suite #3400, 95817 Recruiting
Sacramento, California, United States, 95817
Contact: Laura B. Jones    916-734-4156   
Contact: Nataly Lessa Magner   
Principal Investigator: Nasim Hedayati, Dr.         
Vascular Center,Department of Surgery,UC Davis Health,4860 Y street Recruiting
Sacramento, California, United States, 95817
Contact: Laura b Jones, Mrs.    530-302-5517   
Principal Investigator: Nasim Hedayati, Dr.         
United States, Florida
University of Miami Leonard M.Miller School of Medicine (UMMSM)-UHealth Pulmonary and Critical Care Medicine-Rosenstiel Building Location Recruiting
Miami, Florida, United States, 33136-1015
Contact: Arash Bornak, MD    305-284-4093   
Principal Investigator: Arash Bornak, MD         
United States, Massachusetts
Tufts Medical Center (TMC) (Tufts-New England Medical Center) Recruiting
Boston, Massachusetts, United States, 02111-1552
Contact: Mark Iafrati, MD    617-636-5019   
Principal Investigator: Mark Iafrati, MD         
Room S3-746, Dept of Surgery, UMASS Medical School, 55 Lake Ave North. Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Andres S Schanzer, Dr.    508-856-5599 ext 5088565599   
Principal Investigator: Andres Schanzer, Dr.         
United States, New Jersey
Holy Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Contact: John Rundback, Dr.    201-530-7967   
United States, New York
Mount Sinai St. Luke's hospital Recruiting
New York, New York, United States, 10019-1147
Contact: John C Lantis, Dr.    212-523-5915   
United States, North Carolina
Duke University Medical Center,Durham,2424 Erwin Road Hock Plaza Recruiting
Durham, North Carolina, United States, 27710
Contact: Jennifer Andrews    919-681-4624   
Principal Investigator: William Schuyler Jones, Dr         
United States, Texas
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Austin, Texas, United States, 78756
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UMHAT "Virgin Mary" EOOD,Clinic of Vascular Surgery Recruiting
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Contact: Galin Zhelev, Dr.    +359 89 62 62   
MHAT Sveti Nokolay Chudotvorets EOOD - Lom,Surgery Department,Address 2, Todor Kableshkov str. Recruiting
Lom, Bulgaria, 3600
Contact: Iliyan Petrov, Dr.    +359 888 673 338   
Principal Investigator: Iliyan Petrov, Dr.         
UMHAT "St. Georgi" EAD,Clinic: Vascular Surgery and Angiology 66 "Peshtersko Shosse" Blvd., 8th floor, Hirurgicheski blok Recruiting
Plovdiv, Bulgaria, 4001
Contact: Drago Zhelev, Assoc. Prof.    +359 888 221 320   
Principal Investigator: Drago Zhelev, Assoc. Prof.         
UMBAL Kanev AD - Ruse,Department of Vascular Surgery Address: 2, Nezavisimost str Recruiting
Ruse, Bulgaria, 7002
Contact: Georgi Georgiev, Dr.    +359 888 244 262   
Principal Investigator: Georgi Georgiev, Dr.         
UMHAT "Medica" Ruse Department of Vascular Surgery 35, "Riga", Str Post code: 7013 Ruse, Bulgaria Recruiting
Ruse, Bulgaria, 7013
Contact: Kamen Uzunov, Dr.    00359 886 23 74 81   
Contact: Krasimira Yordanova, Dr.    00359 885 20 73 80   
Principal Investigator: Hristo Georgiev, Dr.         
MHAT National Heart Hospital EAD,Clinic of Vascular Surgery and angiology Recruiting
Sofia, Bulgaria, 1309
Contact: Mario Stankev, Prof.    +359 2 822 31 36   
Acibadem City Clinic MHAT Tokuda, Vascular Surgery and Angiology 51B "Nikola Vaptzarov" Blvd Recruiting
Sofia, Bulgaria, 1407
Contact: Vasil Chervenkov, Prof.    +359 888 337 330   
Principal Investigator: Vasil Chervenkov, Prof.         
UMHAT "St. Ekaterina" EAD, Departement of Vascular Surgery Recruiting
Sofia, Bulgaria, 1431
Contact: Valentin Govedarski, Assoc. Prof.    +359 888 242 418   
Cevni ambulance Recruiting
Hodonín, Czechia, 69501
Contact: Matuska Jiri    00420518341182   
Principal Investigator: Matuska Jiri         
Angiologicka ambulance Recruiting
Ostrava Dubina, Czechia, 700 30
Contact: Dusan Kucera, MD    00420 595633202   
Principal Investigator: Dusan Kucera, MD         
Vseobecna Fakultni Nemocnice v Praze Recruiting
Prague, Czechia, 12802
Contact: Jean-Claude Lubanda, MD    00420 774988566   
Principal Investigator: Jean-Claude Lubanda, MD         
Intitute of Clinical and Experimental Medicine Recruiting
Praha 4, Czechia, 140 21
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Krajska zdravotni a.s., Masarykova nemocnice o.z. Recruiting
Usti nad Labem, Czechia, 40113
Contact: Martin Sauer, MD    420 47 711 2504   
Contact: Olga Mucicova, Mgr    420 477 112 100   
Principal Investigator: Martin Sauer, MD         
Klinik und Poliklinik für Angiologie Universitätsklinikum Leipzig AöR Liebigstr. 20 04103 Leipzig, Germany Recruiting
Leipzig, Saxony, Germany, 04103
Contact: Janin Lenzer    0049-341-97 18774   
Principal Investigator: Andrej Schmidt, Dr.         
Medinos Klinikum Sonneberg Abteilung für Kardiologie/Angiologie - Studienambulanz Neustadter Straße 61 96515 Sonneberg Germany Recruiting
Sonneberg, Thueringen, Germany, 96515
Contact: Jennifer Hofrichter    00493675 821 754   
Principal Investigator: Marcus Thieme, Dr.         
Universitats-Herzzentrum Freiburg Recruiting
Bad Krozingen, Germany, 79189
Contact: Thomas Zeller, MD    0049 76334022431   
Principal Investigator: Thomas Zeller, MD         
Charite Centrum fur Herz - Kreislauf - und Gefassmedizin - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Ursula Rauch, Dr.    030 450 513 794   
Contact: Franziska Bleis    49(0)30 450 513 817   
Principal Investigator: Ursula Rauch, Dr.         
HELIOS Klinikum Berlin-Buch, Klinik fur Angiologie Recruiting
Berlin, Germany, 13125
Contact: Peter Klein-Weigel, MD    30940154900   
Principal Investigator: Peter Klein-Weigel         
Franziskus-Krankenhaus Berlin Withdrawn
Berlin, Germany
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Germany
Contact: Norbert Weiss, MD    +493514583659   
Principal Investigator: Norbert Weiss, MD         
Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD) Recruiting
Duesseldorf, Germany, 40225
Contact: Hubert Schelzig, Prof.    0049 2118107211 / 07219   
Contact: Britta Londong    0049 211 81-07211   
Principal Investigator: Hubert Schelzig, Prof.         
Asklepios Klinik St.Georg-Angiologische Ambulanz Recruiting
Hamburg, Germany, 20099
Contact: Sigrid Nikol, Prof.    401818852401   
Principal Investigator: Sigrid Nikol, Prof.         
Klinik Kösching Krankenhausstr. 19, 85092 Kösching Germany Recruiting
Kösching, Germany, 85092
Contact: Alexander Hansen, Prof.    "Telefon (08456) 71-431   
Principal Investigator: Alexander Hansen, Prof.         
Universitaetsklinikum Muenster Recruiting
Muenster, Germany, 48155
Contact: Holger Reinecke, MD    0049 (0) 251 8346068   
Principal Investigator: Holger Reinecke, MD         
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Recruiting
Szekesfehervar, Fejer, Hungary, 8000
Contact: Rudolf Menesi    0036209831112   
Principal Investigator: Rudolf Menesi         
Szent Imre Egyetemi Oktato Korhaz Recruiting
Budapest, Hungary, 1115
Contact: Katalin Farkas    0036 304648600   
Principal Investigator: Katalin Farkas         
Flor Ferenc County Hospital Recruiting
Kistarcsa, Hungary, 2143
Contact: Zsolt Pecsvarady, MD    0036 209458919   
Principal Investigator: Zsolt Pecsvarady, MD         
B-A-Z County and University Teaching Hospital Recruiting
Miskolc, Hungary, 3526
Contact: Lajos Matyas, MD    0036 646323694   
Principal Investigator: Lajos Matyas, MD         
Josa Andras Megyei Korhaz Recruiting
Nyíregyháza, Hungary, 4400
Contact: Geza Szabo    0036 42599700   
Principal Investigator: Geza Szabo         
Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School) Recruiting
Pecs, Hungary, 7624
Contact: Gabor Menyhei    0036 72 536 000   
Principal Investigator: Gabor Menyhei         
Vascular Surgery Department, Hadassah Ein Karem MC Recruiting
Jerusalem, Israel, 91120
Contact: Asaf Rabin, Dr.    972-2-6775231    ASAFR@HADASSAH.ORG.IL   
Principal Investigator: Asaf Rabin, Dr.         
Vascular Surgery Department Rabin Medical Center Beilinson Hospital, 39 Jabotinski St. Petah Tikva Israel 4941492 Recruiting
Petah Tikva, Israel, 4941492
Contact: Igor Manevych, Dr.    00972-54-4902547   
Principal Investigator: Galit Sivak, Dr.         
The Cardiological Department, The Baruch Padeh Medical Center Recruiting
Poriya, Israel, 15208
Contact: Diab Ghanem, Dr.    04-6652363   
Principal Investigator: Diab Ghanem, Dr.         
North Macedonia
Acibadem Sistina Hospital,Thoracic and Vascular Surgery Recruiting
Skopje, North Macedonia, 1000
Contact: Mitko Karagjozov, Prof.    +389 2 3099 720   
Re-Medika General Hospital,Cardiovascular Surgery Recruiting
Skopje, North Macedonia, 1000
Contact: Vlatko Cvetanovski, Dr.    +389 2 2603 100   
Special Hospital for Surgical Diseases Zan Mitrev Clinic ,Cardiovascular Surgery Recruiting
Skopje, North Macedonia, 1000
Contact: Nikola Hristov, Dr.    +389 (0)2 3091 500   
Szpital Uniwersytecki nr 1 im. dr. A. Jurasza Withdrawn
Bydgoszcz, Poland, 85094
Cathedra and Clinic of Vascular Surgery and Angiology-Klinika Chirurgii Naczyniowej i Angiologii Recruiting
Lublin, Poland, 20-081
Contact: Tomasz Zubilewicz, Prof.    0048 815325707   
Samodzielny Publiczny Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego w Szczecinie Withdrawn
Szczecin, Poland, 2359
Wojewodzki Szpital Specjalistyczny we Wroclawiu, Osrodek Badawczo-Rozwojowy,Intensywnego Nadzoru Kardlologleznego, Recruiting
Wrocław, Poland, 51-124
Contact: Wojciech Witkiewicz, Prof    0048 601703011   
Principal Investigator: Wojciech Witkiewicz, Prof         
United Kingdom
Vascular Research Clinical Research Centre Beaufort Way Southmead Hospital Westbury on Trym Bristol Recruiting
Bristol, United Kingdom, BS10 5NB
Contact: Robert Hinchliffe, Dr.    0044 2087253214   
Principal Investigator: Robert Hinchliffe, Dr.         
Hull And East Yorkshire Women And Children's Hospital-Hull And East Yorkshire Hospitals Nhs Trust Recruiting
Hull, United Kingdom, HU32JZ
Contact: George Edward Smith, MD    00441482675784   
Principal Investigator: George Edward Smith, MD         
Kings College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Chris Manu, MD    0203 299 3704   
Principal Investigator: Chris Manu, MD         
Department of Vascular Research, St George's Hospital Recruiting
London, United Kingdom, SW17 0QT
Contact: Ian Loftus, Prof.    0044 2086721255   
Sponsors and Collaborators
Pluristem Ltd.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pluristem Ltd. Identifier: NCT03006770     History of Changes
Other Study ID Numbers: PLX-CLI-03
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes