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Clinical trialNCT01679990CompletedPhase 2Interventional

Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)

SponsorPluristem Ltd.Enrollment180Intermittent ClaudicationPeripheral Artery Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The objective of the study is to establish the safety profile of Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects comprising of 4 treatment groups: 1. Double treatment of PLX-PAD low dose 2. Double treatment of PLX-PAD high dose 3. Double treatment of Placebo 4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will receive the assigned treatment twice to the affected leg, within 12-weeks interval between each treatment. The study will be comprised of 5 stages: Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by additional injection after 12 weeks and with follow-up of 12 months post second injection
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Alan T Hirsch, MD

    Cardiovascular Division, MMC 508, University of Minnesota Medical school, Minneapolis, MN 55455

    Principal Investigator
    clinicaltrials.gov ↗
  • Berthold Amann, MD

    Franziskus-Krankenhaus, Berlin Germany

    Principal Investigator
    clinicaltrials.gov ↗
  • Bret Weichmann, MD

    Florida research Network, LLC 6800NW 9th Blvd Suite1, Gainesville, Florida 32605

    Principal Investigator
    clinicaltrials.gov ↗
  • Changyoung Lim, MD

    CHA Bundang Medical Center, CHA University, 59 Yatap-ro Bundang-Gu, Seongnam-Si, Gyeonggi-do 463-712, Korea

    Principal Investigator
    clinicaltrials.gov ↗
  • Christine Espinola-Klein, MD

    Johannes Gutenberg University Mainz

    Principal Investigator
    clinicaltrials.gov ↗
  • David L Fried, MD

    Omega Medical Research, Warwick, RI 02886

    Principal Investigator
    clinicaltrials.gov ↗
  • Dokyun Kim, MD

    National Health Insurance Service Ilsan Hospital

    Principal Investigator
    clinicaltrials.gov ↗
  • Douglas Denham, DO

    Clinical Trials of Texas, Inc. 7940 Floyd Curl drive, Suite 700, San Antonio, Texas 78229

    Principal Investigator
    clinicaltrials.gov ↗
  • Erwin Blessing, MD

    Klinikum Karlsbad-Langensteinbach

    Principal Investigator
    clinicaltrials.gov ↗
  • Holger Reinecke, MD

    Universitätsklinikum Münster

    Principal Investigator
    clinicaltrials.gov ↗
  • Jaeseung Shin, MD

    Korea University

    Principal Investigator
    clinicaltrials.gov ↗
  • James Hampsey, MD

    Tampa Bay Medical research, 3251 McMullen Booth Road, STE 303, Clearwater, FL 33761

    Principal Investigator
    clinicaltrials.gov ↗
  • Jeffrey W Olin, DO

    Cardiovascular Institute, Mount Sinai School of Medicine , One Gustave L. Levy Place, New York, NY 10029

    Principal Investigator
    clinicaltrials.gov ↗
  • Joonhyuk Kong, MD

    Kangbuk Samsung Hospital

    Principal Investigator
    clinicaltrials.gov ↗
  • Kathleen Cullen, MD

    DMI Research, 6699 90th Ave. North, Pinellas Park FL

    Principal Investigator
    clinicaltrials.gov ↗
  • Kwangjo Cho, MD

    Dong-A University Hospital

    Principal Investigator
    clinicaltrials.gov ↗
  • Malcolm Foster, MD

    Turkey Creek Medical Center, Knoxville TN 37934

    Principal Investigator
    clinicaltrials.gov ↗
  • Mohler Emile, M.D

    Hospital of the University of Pennsylvania, Philadelphia, PA 19104

    Principal Investigator
    clinicaltrials.gov ↗
  • Nadarajah Janaki, M.D

    Aiyan Diabetes Center, Evans, GA 30809

    Principal Investigator
    clinicaltrials.gov ↗
  • Norbert Weiss, MD

    Universitätsklinikum Carl Gustav Carus, Dresden, Germany

    Principal Investigator
    clinicaltrials.gov ↗
  • Oliver Müller, MD

    Universitätsklinik Heidelberg

    Principal Investigator
    clinicaltrials.gov ↗
  • Reuven Zimlichman, MD

    Edith Wolfson Medical Center,62 HaLohamim Street, Holon, Israel

    Principal Investigator
    clinicaltrials.gov ↗
  • Schulyer Jones, MD

    Duke University,Durham, North Carolina, 27705, USA

    Principal Investigator
    clinicaltrials.gov ↗
  • Sibu P. Saha, MD

    University of Kentucky, Lexington, KY 40506-0057

    Principal Investigator
    clinicaltrials.gov ↗
  • Sigrid Nikol, MD

    ASKLEPIOS Klinik St. Georg, Hamburg Germany

    Principal Investigator
    clinicaltrials.gov ↗
  • Stefan Betge, MD

    Jena University Hospital

    Principal Investigator
    clinicaltrials.gov ↗
  • Sungwon Chung, MD

    Pusan National University Hospital 179 Gudeok-Ro Seo-Gu, Busan, 602-739, Korea

    Principal Investigator
    clinicaltrials.gov ↗
  • Thomas Zeller, MD

    Universtiäts-Herzzentrum Freiburg und Bad-Krozingen

    Principal Investigator
    clinicaltrials.gov ↗
  • Weonyong Lee, MD

    Hallym University Sacred Heart Hospital 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 431-796, Korea

    Principal Investigator
    clinicaltrials.gov ↗
  • Yousun Hong, MD

    Ajou University School of Medicine

    Principal Investigator
    clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

34 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Germany
  • Universtiäts-Herzzentrum Freiburg Und Bad-Krozingen

    Bad Krozingen, Germany

  • Franziskus-Krankenhaus

    Berlin, Germany

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Germany

  • Asklepios Klinik St. Georg

    Hamburg, Germany

  • Universitätsklinik Heidelberg

    Heidelberg, Germany

  • Universitätsklinikum Jena

    Jena, Germany

  • Srh Klinikum Karlsbad-Langensteinbach

    Karlsbad, Germany

  • Universitätsmedizin Der Johannes Gutenberg-Universität Mainz

    Mainz, Germany

  • Universitätsklinikum Münster

    Münster, Germany

Israel
  • "mor" Instituite, Horev M.C

    Haifa, Israel

  • Edith Wolson Medical Center

    Holon, Israel

South Korea
  • Dong-A University Hospital

    Seo-gu, Busan, South Korea

  • Korea University Ansan Hospital

    Ansan, Gyeonggi-do, South Korea

  • National Health Insurance Service Ilsan Hospital

    Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea

  • Ajou University Hospital

    Suwon, Gyeonggi-do, South Korea

  • Dr. Sungwon Chung

    Busan, South Korea

  • Dr. Changyoung Lim

    Gyeonggi-do, South Korea

  • Dr. Weonyong Lee

    Gyeonggi-do, South Korea

  • Kangbuk Samsung Medical Center

    Seoul, South Korea

United States
  • Cardiology, P. C. and Center for Therapeutic Angiogenesis

    Birmingham, Alabama, United States

  • Tampa Bay Medical Research

    Clearwater, Florida, United States

  • Florida Researc Network, Llc

    Gainesville, Florida, United States

  • Dmi Research

    Pinellas Park, Florida, United States

  • Dr. Nadarajah Janaki

    Evans, Georgia, United States

  • Northwestern University

    Chicago, Illinois, United States

  • University of Kentucky Research Foundation

    Lexington, Kentucky, United States

  • Cardiovascular Division, Mmc, University of Minnesota

    Minneapolis, Minnesota, United States

  • Cardiovascular Institute, Mount Sinai School of Medicine

    New York, New York, United States

  • Duke University

    Durham, North Carolina, United States

  • Dr. Mohler Emile

    Philadelphia, Pennsylvania, United States

  • Omega Medical Center

    Warwick, Rhode Island, United States

  • Turkey Creek Medical Center

    Knoxville, Tennessee, United States

  • Clinical Trials of Texas

    San Antonio, Texas, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Double PlaceboPLX-PAD Low dosePLX-PAD high dosesHigh dose +Placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
5 Nov 2012
Primary completion
29 Mar 2018
Completion
9 Feb 2019
Last update posted
12 Feb 2019
Registered enrollment
180
Registry id
NCT01679990
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.