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

Summary

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

Conditions

• Intermittent Claudication
• Peripheral Artery Disease

Interventions

BIOLOGICAL

PLX-PAD Low dose

BIOLOGICAL

PLX-PAD high doses

BIOLOGICAL

Double Placebo

BIOLOGICAL

high dose +Placebo

Sponsors & Collaborators

• Pluristem Ltd.

  lead INDUSTRY

Principal Investigators

• Douglas Denham, DO · Clinical Trials of Texas, Inc. 7940 Floyd Curl drive, Suite 700, San Antonio, Texas 78229

• James Hampsey, MD · Tampa Bay Medical research, 3251 McMullen Booth Road, STE 303, Clearwater, FL 33761

• Schulyer Jones, MD · Duke University,Durham, North Carolina, 27705, USA

• Bret Weichmann, MD · Florida research Network, LLC 6800NW 9th Blvd Suite1, Gainesville, Florida 32605

• Jeffrey W Olin, DO · Cardiovascular Institute, Mount Sinai School of Medicine , One Gustave L. Levy Place, New York, NY 10029

• Alan T Hirsch, MD · Cardiovascular Division, MMC 508, University of Minnesota Medical school, Minneapolis, MN 55455

• Sibu P. Saha, MD · University of Kentucky, Lexington, KY 40506-0057

• David L Fried, MD · Omega Medical Research, Warwick, RI 02886

• Berthold Amann, MD · Franziskus-Krankenhaus, Berlin Germany

• Norbert Weiss, MD · Universitätsklinikum Carl Gustav Carus, Dresden, Germany

• Sigrid Nikol, MD · ASKLEPIOS Klinik St. Georg, Hamburg Germany

• Malcolm Foster, MD · Turkey Creek Medical Center, Knoxville TN 37934

• Kathleen Cullen, MD · DMI Research, 6699 90th Ave. North, Pinellas Park FL

• Mohler Emile, M.D · Hospital of the University of Pennsylvania, Philadelphia, PA 19104

• Nadarajah Janaki, M.D · Aiyan Diabetes Center, Evans, GA 30809

• Reuven Zimlichman, MD · Edith Wolfson Medical Center,62 HaLohamim Street, Holon, Israel

• Changyoung Lim, MD · CHA Bundang Medical Center, CHA University, 59 Yatap-ro Bundang-Gu, Seongnam-Si, Gyeonggi-do 463-712, Korea

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

• Sungwon Chung, MD · Pusan National University Hospital 179 Gudeok-Ro Seo-Gu, Busan, 602-739, Korea

• Yousun Hong, MD · Ajou University School of Medicine

• Jaeseung Shin, MD · Korea University

• Kwangjo Cho, MD · Dong-A University Hospital

• Dokyun Kim, MD · National Health Insurance Service Ilsan Hospital

• Joonhyuk Kong, MD · Kangbuk Samsung Hospital

• Stefan Betge, MD · Jena University Hospital

• Holger Reinecke, MD · Universitätsklinikum Münster

• Oliver Müller, MD · Universitätsklinik Heidelberg

• Erwin Blessing, MD · Klinikum Karlsbad-Langensteinbach

• Thomas Zeller, MD · Universtiäts-Herzzentrum Freiburg und Bad-Krozingen

• Christine Espinola-Klein, MD · Johannes Gutenberg University Mainz

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-05

Primary Completion

2018-03-29

Completion

2019-02-09

Countries

• United States
• Germany
• Israel
• South Korea

Study Locations