Using GM-CSF to treat Peripheral Artery Disease
Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease: The GPAD-3 Study
PHASE2 · Emory University · NCT03304821
This study is testing if a new treatment called GM-CSF can help people with peripheral artery disease feel better and improve their blood flow.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT03304821 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of granulocyte-macrophage colony stimulating factor (GM-CSF) on patients with peripheral artery disease (PAD) and intermittent claudication. Participants will be randomly assigned to receive either GM-CSF or a placebo through subcutaneous injections three times a week for three weeks. The study aims to determine if GM-CSF can improve symptoms and blood flow in individuals suffering from PAD. After a four-week screening phase, participants will undergo baseline testing and follow-up assessments to evaluate the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates include post-menopausal women or surgically sterile females with documented symptomatic PAD and a history of intermittent claudication.
Not a fit: Patients with non-compressible arteries or those who are not clinically stable may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients with peripheral artery disease.
How similar studies have performed: Previous studies have shown improvements in claudication symptoms with GM-CSF, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Documented symptomatic PAD * 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. * On statin therapy for previous 3 months prior to enrollment, unless statin intolerant. * 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. * 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. * On appropriate and stable medical therapy for atherosclerosis for at least 2 months prior to enrollment. * Able to give informed consent. * Diabetics with a dilated eye exam excluding proliferative retinopathy in the previous 12 months prior to enrollment. Exclusion Criteria: * Recent or current active infections (treated with antibiotics) * Recent (6 months prior to randomization) or current active cancer undergoing treatment * Recent (3 months prior to randomization) change in statin or cilostazol therapy * Critical limb ischemia either chronic (Rutherford Class \>II) or acute ischemia manifested by rest pain, ulceration, or gangrene * Recent (3 months prior to randomization) lower extremity vascular surgery, angioplasty or lumbar sympathectomy * Planned participation in a structured exercise treatment protocol in the future or within period of study * Prior myeloid malignancy * Recent (3 months prior to randomization) Unstable angina, myocardial infarction, transient ischemic attack (TIA), stroke or revascularization * Severe heart failure (Class III or IV) or heart muscle disease * Limitation on exercise for symptoms other than intermittent claudication such as arthritis or dyspnea * Below- or above-knee amputation; wheelchair confinement * Use of a walking aid other than a cane * Walking impairment for reasons other than PAD e.g. Parkinson's disease * Uncontrolled diabetes mellitus (defined as HbA1c \> 10.0) * Chronic renal disease (creatinine of \>2.5 mg/dl) or hepatic disease (\> 3 X elevations in aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) * White blood cell count \< 3k/cmm * Hemoglobin (HGB) \< 10g/dL * Blood Pressure Systolic \>180 and/or Diastolic \>100 * Taking Immunosuppressant drugs * Ophthalmologic conditions associated with a neo-vascular response * 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 * Inability to attend study visits
Where this trial is running
Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Arshed Quyyumi, MD — Emory University
- Study coordinator: Kiran Ejaz
- Email: Kiran.ejaz@emory.edu
- Phone: 404-712-0169
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Artery Disease, Atherosclerotic peripheral artery disease, Granulocyte-macrophage colony stimulating factor, Atherosclerosis, Cardiology, Vascular disease