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

NCT01679990 | Completed Phase 2

• 1 other identifier: PLX 1204-01
• Study Type: interventional
• Target: 180
• Locations: 4 countries
• Sites: 34

Brief 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. 1.Double treatment of PLX-PAD low dose
2. 2.Double treatment of PLX-PAD high dose
3. 3.Double treatment of Placebo
4. 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.

Conditions

Intermittent Claudication; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Log ratio of week 52 maximal walking distance(MWD)to baseline MWD

  12 months

Study Arms (4)

PLX-PAD Low dose

EXPERIMENTAL

PLX-PAD double low doses

Biological: PLX-PAD Low dose

PLX-PAD high doses

ACTIVE COMPARATOR

PLX-PAD double high dose

Biological: PLX-PAD high doses

Placebo

PLACEBO COMPARATOR

Double Placebo doses

Biological: Double Placebo

PLX-PAD high dose +Placebo

EXPERIMENTAL

High dose+Placebo

Biological: high dose +Placebo

Interventions

PLX-PAD Low dose BIOLOGICAL

PLX-PAD Low dose

PLX-PAD high doses BIOLOGICAL

PLX-PAD high doses

Double Placebo BIOLOGICAL

Placebo

high dose +Placebo BIOLOGICAL

PLX-PAD high dose +Placebo

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female subjects between 45 to 85 years of age (inclusive) at the time of screening visit.
• Subjects with a diagnosis of peripheral artery disease, secondary to atherosclerosis, confirmed by one of the following criteria assessed at the screening visit:
• Resting ankle-brachial index (ABI) ≤ 0.80 or
• Resting ABI ≤ 0.90 and \>20% decrease in ABI from rest to exercise when measured within 1 minute after treadmill exercise or
• Toe-brachial index (TBI) ≤ 0.60
• Lifestyle-limiting, moderate to severe claudication (symptoms present and stable for \> 6 months and not significantly changed within the past 3 months prior to screening).
• Evidence of significant (\>50%) stenosis infra-inguinal occlusive disease as confirmed by documented results from Duplex, MRA, CTA and/or contrast angiogram completed within 3 months prior to screening.
• The longest maximal walking distance (MWD) from the Screening Period exercise treadmill tests (ETT), utilizing a modified Gardner Protocol (Appendix I), must be between 1 and 10 minutes (inclusive).
• Subjects who have persistent claudication symptoms despite having been recommended an exercise program if feasible, and or despite having been on a stable dose of Cilostazol, if indicated. Subjects should be Cilostazol free for at least 2 weeks prior to the first ETT.
• Subjects should be receiving standard of care drugs for vascular disease including anti-platelet agent(s) and statin medication, as well as anti-hypertensive medication(s) and oral hypoglycemic agents/insulin, if indicated.
• Signed written informed consent.

You may not qualify if:

• Ischemic rest pain; ulceration or gangrene (Fontaine class III-IV; Rutherford category 4-6).
• Failed lower extremity arterial reconstruction (surgical or endovascular) or sympathectomy within the prior one month of screening.
• Planned revascularization (surgical or endovascular intervention) within 12 months after screening.
• Lower extremity arteries inflow obstruction (defined as a greater than 50% stenosis of aorta, iliac and/or common femoral arteries).
• History of Buerger's disease.
• Uncontrolled hypertension (defined as diastolic blood pressure \> 100 mmHg or systolic blood pressure \> 180 mmHg during screening).
• Uncontrolled diabetes defined as glucose control HbA1c \> 9% at screening.
• Life-threatening ventricular arrhythmia - except in subjects with an implantable cardiac-defibrillator.
• Serum Creatinine level\>2.5mg/dl.
• SGPT (ALT), SGOT (AST) \>2.5 x upper limit of normal range.
• Hemoglobin \< 10 g/dl.
• Unstable cardiovascular disease defined as myocardial infarction (STEMI or NSTEMI) within 3 months prior to screening, or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged episodes.
• Transient Ischemic Attack (TIA)/Stroke within 3 months prior to screening.
• Subjects with severe congestive heart failure symptoms (i.e. NYHA Stage III to IV).
• Subjects with Implant of mechanical prosthetic heart valve(s).

Sponsors & Collaborators

• Pluristem Ltd.: lead

Study Sites (34)

Cardiology, P. C. and Center for Therapeutic Angiogenesis

Birmingham, Alabama, 35211, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Florida Researc Network, LLC

Gainesville, Florida, 32605, United States

Location

DMI Research

Pinellas Park, Florida, 33782, United States

Location

Dr. Nadarajah Janaki

Evans, Georgia, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kentucky Research Foundation

Lexington, Kentucky, 40506-0057, United States

Location

Cardiovascular Division, MMC, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Cardiovascular Institute, Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Duke University

Durham, North Carolina, United States

Location

Dr. Mohler Emile

Philadelphia, Pennsylvania, United States

Location

Omega Medical Center

Warwick, Rhode Island, 02886, United States

Location

Turkey Creek Medical Center

Knoxville, Tennessee, 10820, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Universtiäts-Herzzentrum Freiburg und Bad-Krozingen

Bad Krozingen, 79189, Germany

Location

Franziskus-Krankenhaus

Berlin, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

ASKLEPIOS Klinik St. Georg

Hamburg, Germany

Location

Universitätsklinik Heidelberg

Heidelberg, 69129, Germany

Location

Universitätsklinikum Jena

Jena, 97747, Germany

Location

SRH Klinikum Karlsbad-Langensteinbach

Karlsbad, 76307, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

"Mor" Instituite, Horev M.C

Haifa, Israel

Location

Edith Wolson Medical Center

Holon, 58100, Israel

Location

Dong-A University Hospital

Seo-gu, Busan, 602-715, South Korea

Location

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 425-707, South Korea

Location

National Health Insurance Service Ilsan Hospital

Ilsandong-gu, Goyang-si, Gyeonggi-do, 410-719, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 443-380, South Korea

Location

Dr. Sungwon Chung

Busan, 602-739, South Korea

Location

Dr. Weonyong Lee

Gyeonggi-do, 431-796, South Korea

Location

Dr. Changyoung Lim

Gyeonggi-do, 463-712, South Korea

Location

Kangbuk Samsung Medical Center

Seoul, 110-746, South Korea

Location

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Douglas Denham, DO

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

  PRINCIPAL INVESTIGATOR

• James Hampsey, MD

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

  PRINCIPAL INVESTIGATOR

• Schulyer Jones, MD

  Duke University,Durham, North Carolina, 27705, USA

  PRINCIPAL INVESTIGATOR

• Bret Weichmann, MD

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

  PRINCIPAL INVESTIGATOR

• Jeffrey W Olin, DO

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

  PRINCIPAL INVESTIGATOR

• Alan T Hirsch, MD

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

  PRINCIPAL INVESTIGATOR

• Sibu P. Saha, MD

  University of Kentucky, Lexington, KY 40506-0057

  PRINCIPAL INVESTIGATOR

• David L Fried, MD

  Omega Medical Research, Warwick, RI 02886

  PRINCIPAL INVESTIGATOR

• Berthold Amann, MD

  Franziskus-Krankenhaus, Berlin Germany

  PRINCIPAL INVESTIGATOR

• Norbert Weiss, MD

  Universitätsklinikum Carl Gustav Carus, Dresden, Germany

  PRINCIPAL INVESTIGATOR

• Sigrid Nikol, MD

  ASKLEPIOS Klinik St. Georg, Hamburg Germany

  PRINCIPAL INVESTIGATOR

• Malcolm Foster, MD

  Turkey Creek Medical Center, Knoxville TN 37934

  PRINCIPAL INVESTIGATOR

• Kathleen Cullen, MD

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

  PRINCIPAL INVESTIGATOR

• Mohler Emile, M.D

  Hospital of the University of Pennsylvania, Philadelphia, PA 19104

  PRINCIPAL INVESTIGATOR

• Nadarajah Janaki, M.D

  Aiyan Diabetes Center, Evans, GA 30809

  PRINCIPAL INVESTIGATOR

• Reuven Zimlichman, MD

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

  PRINCIPAL INVESTIGATOR

• Changyoung Lim, MD

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

  PRINCIPAL INVESTIGATOR

• Weonyong Lee, MD

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

  PRINCIPAL INVESTIGATOR

• Sungwon Chung, MD

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

  PRINCIPAL INVESTIGATOR

• Yousun Hong, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jaeseung Shin, MD

  Korea University

  PRINCIPAL INVESTIGATOR

• Kwangjo Cho, MD

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

• Dokyun Kim, MD

  National Health Insurance Service Ilsan Hospital

  PRINCIPAL INVESTIGATOR

• Joonhyuk Kong, MD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

• Stefan Betge, MD

  Jena University Hospital

  PRINCIPAL INVESTIGATOR

• Holger Reinecke, MD

  Universitätsklinikum Münster

  PRINCIPAL INVESTIGATOR

• Oliver Müller, MD

  Universitätsklinik Heidelberg

  PRINCIPAL INVESTIGATOR

• Erwin Blessing, MD

  Klinikum Karlsbad-Langensteinbach

  PRINCIPAL INVESTIGATOR

• Thomas Zeller, MD

  Universtiäts-Herzzentrum Freiburg und Bad-Krozingen

  PRINCIPAL INVESTIGATOR

• Christine Espinola-Klein, MD

  Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2012
• First Posted: September 6, 2012
• Study Start: November 5, 2012
• Primary Completion: March 29, 2018
• Study Completion: February 9, 2019
• Last Updated: February 12, 2019

Record last verified: 2017-01

Locations

DE (9); KR (8); US (15); IL (2)