RECRUITING

Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease

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Conditions

Peripheral Artery Disease (PAD)Atherosclerotic peripheral artery diseaseGranulocyte-macrophage colony stimulating factor (GM-CSF)AtherosclerosisCardiologyVascular disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Peripheral artery disease (PAD) is a disease in which plaque builds up in the arteries that carry blood to the head, organs, and limbs. PAD usually occurs in the arteries in the legs, but can affect any arteries. Over time, plaque can harden and narrow the arteries which limits the flow of oxygen-rich blood to organs and other parts of the body. Blocked blood flow to the arteries can cause pain and numbness. The pain is usually worse with exercise and gets better with rest. PAD can raise the risk of getting an infection which could lead to tissue death and amputation. This study is investigating whether granulocyte-macrophage colony stimulating factor (GM-CSF) improves symptoms and blood flow in people with PAD. GM-CSF is a drug that is used to stimulate the bone marrow to release stem cells. Participants in the study will be randomly selected to receive GM-CSF or a placebo. After a four-week screening phase, participants will receive injections of GM-CSF or a placebo three times a week for three-weeks. Three months later, participants will again receive injections of GM-CSF or placebo three times a week for three-weeks. At six months, the study team will follow up to see if the group that received GM-CSF had more improvement than the group that received placebo.

Official Title

Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease: The GPAD-3 Study

Quick Facts

Study Start:2017-12-19
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03304821

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female subjects must be (a) post-menopausal, (b) surgically sterile or (c) use adequate birth control and have a negative pregnancy test within 3 days prior to administration of study drug and should not be breastfeeding.
  2. * Documented symptomatic PAD
  3. * Clinically stable (at least 2 months prior to enrollment) history of intermittent claudication or walking impairment (Rutherford Class II) with no change in symptom severity in the 2 months prior to screening.
  4. * On statin therapy for previous 3 months prior to enrollment, unless statin intolerant.
  5. * Peak Walking Time (PWT) between 1 and 12 minutes on a standardized Gardner treadmill protocol or modified Gardner protocol or less than 12 minutes on a modified Bruce protocol in case PWT on Gardner protocol is more than 12 minutes.
  6. * A Doppler-derived ankle-brachial index (ABI) of \< 0.90 in the symptomatic limb after 10 minutes of rest at screening. For subjects with an ABI of \>1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of \< 0.70 must be obtained for subject qualification, or if ABI is \> 0.9 to 1.0 , and a reduction of 20% in ABI measured within 1 minute of treadmill testing.
  7. * On appropriate and stable medical therapy for atherosclerosis for at least 2 months prior to enrollment.
  8. * Able to give informed consent.
  9. * Diabetics with a dilated eye exam excluding proliferative retinopathy in the previous 12 months prior to enrollment.
  1. * Recent or current active infections (treated with antibiotics)
  2. * Recent (6 months prior to randomization) or current active cancer undergoing treatment
  3. * Recent (3 months prior to randomization) change in statin or cilostazol therapy
  4. * Critical limb ischemia either chronic (Rutherford Class \>II) or acute ischemia manifested by rest pain, ulceration, or gangrene
  5. * Recent (3 months prior to randomization) lower extremity vascular surgery, angioplasty or lumbar sympathectomy
  6. * Planned participation in a structured exercise treatment protocol in the future or within period of study
  7. * Prior myeloid malignancy
  8. * Recent (3 months prior to randomization) Unstable angina, myocardial infarction, transient ischemic attack (TIA), stroke or revascularization
  9. * Severe heart failure (Class III or IV) or heart muscle disease
  10. * Limitation on exercise for symptoms other than intermittent claudication such as arthritis or dyspnea
  11. * Below- or above-knee amputation; wheelchair confinement
  12. * Use of a walking aid other than a cane
  13. * Walking impairment for reasons other than PAD e.g. Parkinson's disease
  14. * Uncontrolled diabetes mellitus (defined as HbA1c \> 10.0)
  15. * Chronic renal disease (creatinine of \>2.5 mg/dl) or hepatic disease (\> 3 X elevations in aspartate aminotransferase (AST) and alanine aminotransferase (ALT))
  16. * White blood cell count \< 3k/cmm
  17. * Hemoglobin (HGB) \< 10g/dL
  18. * Blood Pressure Systolic \>180 and/or Diastolic \>100
  19. * Taking Immunosuppressant drugs
  20. * Ophthalmologic conditions associated with a neo-vascular response
  21. * Alcohol or drug abuse, or any other disease process that, in the opinion of the PI, will interfere with the ability of the patient to participate in the study
  22. * Inability to attend study visits

Contacts and Locations

Study Contact

Kiran Ejaz
CONTACT
404-712-0169
Kiran.ejaz@emory.edu

Principal Investigator

Arshed Quyyumi, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University Hospital
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Arshed Quyyumi, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-12-19
Study Completion Date2025-12

Study Record Updates

Study Start Date2017-12-19
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Atherosclerotic peripheral artery disease
  • Granulocyte-macrophage colony stimulating factor (GM-CSF)
  • Atherosclerosis
  • Cardiology
  • Vascular disease

Additional Relevant MeSH Terms

  • Peripheral Artery Disease (PAD)