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Intermittent ClaudicationPhase 2NCT01679990

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

A Phase 2 study testing PLX-PAD Low dose and PLX-PAD high doses in people with Intermittent Claudication and Peripheral Artery Disease, run by Pluristem Ltd. at 34 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 85 years
What is being tested?
PLX-PAD Low dose and PLX-PAD high doses
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
34 sitesin 4 countries
Study dates
5 Nov 2012to 9 Feb 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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).
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  • 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).
  • Pulmonary disease requiring supplemental oxygen treatment on a daily basis.
  • Severe, active infection of the involved extremity(ies), including osteomyelitis, fasciitis, or severe/purulent cellulitis.
  • History of malignancy within 5 years prior screening requiring chemotherapy and/or radiotherapy and/or immunotherapy, excluding basal or squamous cell carcinoma of the skin.
  • Exercise is limited by any condition other than IC, including but not limited to congestive heart failure, chronic pulmonary disease, angina pectoris, or degenerative joint disease.
  • Uninterrupted use of warfarin or non-steroidal anti-inflammatory agents (with the exception of ibuprofen at doses up to 1,200 mg/day or Diclofenac at dose of 75mg/day).
  • Subjects who are on oral anticoagulant therapy (warfarin, dabigatran, apixaban, endoxaban and rivaroxaban). Unless, upon primary care physician and/or Investigator's discretion the subjects who are on warfarin treatment can switch to Low Molecular Weight Heparin treatment (such as: Clexane) 5-7 days prior study treatment administration and return to warfarin treatment 24 hours post study treatment administration.
  • Subjects who are taking immunosuppressive treatment (including high dose steroids).
  • Known allergies to protein products (Bovine serum, or recombinant trypsin) used in the cell production process.
  • Known sensitivity to Gentamycin.
  • Known sensitivity to antihistamine drugs.
  • History of hospitalization due to allergic/hypersensitivity reaction to any substance (e.g. Food or drug).
  • Medical history of Human Immunodeficiency Virus (HIV) or syphilis positivity at time of screening.
  • Known active Hepatitis B, or Hepatitis C infection at the time of screening.
  • Pregnant or breast-feeding women or women of childbearing age not protected by an effective contraceptive method of birth control (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide).
  • In the opinion of the Investigator, the subject is unsuitable for participating in the study.
  • Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s).
  • Subjects that have prior exposure to gene or cell based therapy.
  • Subjects who are legally detained in an official institute.

Trial locations and contacts

34 sites in 4 countries.

34 sites in 4 countries

United States15 sites

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

    Birmingham, Alabama, 35211

  • Northwestern University

    Chicago, Illinois, 60611

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • Duke University

    Durham, North Carolina

  • Dr. Nadarajah Janaki

    Evans, Georgia

  • Florida Researc Network, LLC

    Gainesville, Florida, 32605

  • Turkey Creek Medical Center

    Knoxville, Tennessee, 10820

  • University of Kentucky Research Foundation

    Lexington, Kentucky, 40506-0057

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Cardiovascular Division, MMC, University of Minnesota

    Minneapolis, Minnesota, 55455

  • Cardiovascular Institute, Mount Sinai School of Medicine

    New York, New York, 10029

  • Dr. Mohler Emile

    Philadelphia, Pennsylvania

  • DMI Research

    Pinellas Park, Florida, 33782

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Omega Medical Center

    Warwick, Rhode Island, 02886

Other trials in United States

Germany9 sites

  • Universtiäts-Herzzentrum Freiburg und Bad-Krozingen

    Bad Krozingen, 79189

  • Franziskus-Krankenhaus

    Berlin

  • Universitätsklinikum Carl Gustav Carus

    Dresden

  • ASKLEPIOS Klinik St. Georg

    Hamburg

  • Universitätsklinik Heidelberg

    Heidelberg, 69129

  • Universitätsklinikum Jena

    Jena, 97747

  • SRH Klinikum Karlsbad-Langensteinbach

    Karlsbad, 76307

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Münster

    Münster, 48149

Other trials in Germany

South Korea8 sites

  • Korea University Ansan Hospital

    Ansan, Gyeonggi-do, 425-707

  • Dr. Sungwon Chung

    Busan, 602-739

  • Dr. Weonyong Lee

    Gyeonggi-do, 431-796

  • Dr. Changyoung Lim

    Gyeonggi-do, 463-712

  • National Health Insurance Service Ilsan Hospital

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

  • Dong-A University Hospital

    Seo-gu, Busan, 602-715

  • Kangbuk Samsung Medical Center

    Seoul, 110-746

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 443-380

Other trials in South Korea

Israel2 sites

  • "Mor" Instituite, Horev M.C

    Haifa

  • Edith Wolson Medical Center

    Holon, 58100

Other trials in Israel

About this study

Official title: A Phase II, Randomized, Double-Blind, Multicenter, Multinational, Placebo-Controlled, Parallel- Groups Study to Evaluate the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cells for the Treatment of Subjects With Intermittent Claudication (IC)

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

Being tested
PLX-PAD Low dose, PLX-PAD high doses, Double Placebo, high dose +Placebo
Medical subject headings
Intermittent Claudication, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLX-PAD Low doseBiological

  • PLX-PAD high dosesBiological

  • Double PlaceboBiological

  • high dose +PlaceboBiological

Study groups in NCT01679990
Study groupRoleWhat they receive
PLX-PAD Low doseExperimentalPLX-PAD double low doses
Receives: Biological: PLX-PAD Low dose
PLX-PAD high dosesActive comparatorPLX-PAD double high dose
Receives: Biological: PLX-PAD high doses
PlaceboPlacebo comparatorDouble Placebo doses
Receives: Biological: Double Placebo
PLX-PAD high dose +PlaceboExperimentalHigh dose+Placebo
Receives: Biological: high dose +Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2012 (estimated)
  2. Study start5 Nov 2012
  3. Primary completion29 Mar 2018
  4. Study completion9 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01679990
Sponsor's protocol ID
PLX 1204-01
Status last verified
Jan 2017
First submitted
2 Sep 2012
Last updated
12 Feb 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PLX-PAD Low dose and PLX-PAD high doses in people with Intermittent Claudication and Peripheral Artery Disease, run by Pluristem Ltd. at 34 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Germany, South Korea, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Log ratio of week 52 maximal walking distance(MWD)to baseline MWD (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01679990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.

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