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Can a bone marrow stimulant help people with leg artery disease walk farther?

NCT ID NCT03304821

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 13, 2026 · Updated 4 times

Summary

This study tested whether a drug called GM-CSF can improve symptoms and blood flow in people with peripheral artery disease (PAD), a condition where plaque narrows leg arteries, causing pain and limiting walking. 151 participants received either GM-CSF or a placebo for two 3-week treatment periods. The main goal was to see if GM-CSF increased the distance they could walk in 6 minutes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GM-CSF (also called Sargramostim or Leukine)
What this could lead to
If it works, this could point toward a treatment that improves walking ability and blood flow in people with peripheral artery disease.
What could go wrong
This is a Phase 2 trial with 151 participants, so results are still early. The drug may not show significant benefit over placebo, and side effects like injection site reactions or bone pain are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

114 people

The number who actually took part.

Started

Dec 2017

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.