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Growth Factor

GM-CSF for Peripheral Arterial Disease (GPAD-3 Trial)

Phase 2

Recruiting

Led By Arshed Quyyumi, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Documented symptomatic PAD

Must not have

Prior myeloid malignancy

Below- or above-knee amputation; wheelchair confinement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 3, month 6, month 9, follow-up years 1, 2, and 3

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is investigating whether 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 will be randomly selected to receive GM-CSF or a placebo.

Who is the study for?

This trial is for people with Peripheral Arterial Disease (PAD) who have been on statin therapy, can consent to the study, and have stable PAD symptoms. They must not have severe heart failure, recent major cardiovascular events or surgeries, uncontrolled diabetes, active cancer treatment, or any condition that would limit participation.

What is being tested?

The trial tests if GM-CSF injections improve blood flow and symptoms in PAD patients compared to a placebo. Participants will receive either GM-CSF or placebo shots three times weekly for two three-week periods with a follow-up at six months to assess improvement.

What are the potential side effects?

Potential side effects of GM-CSF may include bone pain, fatigue, fever, headache and injection site reactions. It's also possible it could cause an immune system reaction affecting normal cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My screening showed poor blood flow in my leg.

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I have been diagnosed with painful leg artery disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a blood cancer affecting my bone marrow before.

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I have had an amputation below or above the knee, or I use a wheelchair.

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I use a walking aid that is not a cane.

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I do not have severe kidney or liver disease.

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I am currently taking drugs that suppress my immune system.

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I cannot attend the study visits.

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I am currently being treated for an infection with antibiotics.

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My walking is impaired due to a condition other than PAD, like Parkinson's.

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I have severe leg pain, ulcers, or gangrene due to poor blood flow.

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I have an eye condition that involves abnormal blood vessel growth.

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I am currently being treated for cancer or have been in the last 6 months.

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I have severe heart failure or heart muscle disease.

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My diabetes is not under control (HbA1c > 10.0).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 3, month 6, month 9, follow-up years 1, 2, and 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 3, month 6, month 9, follow-up years 1, 2, and 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, month 6, month 9, follow-up years 1, 2, and 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 6-minute walk distance

Secondary study objectives

Change in 36-item Short-Form Health Survey (SF-36) Score

Erythrocyte Indices

Change in Claudication Onset Time (COT)

+5 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GM-CSFExperimental Treatment1 Intervention

Participants receiving 500µg of granulocyte-macrophage colony stimulating factor (GM-CSF), administered subcutaneously. Prior to randomization to a study arm, eligible participants will be trained to perform subcutaneous injections and instructed to walk at least three times a day until they develop claudication or symptomatic limitation for 4 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants receiving 500µg of a placebo, administered subcutaneously. Prior to randomization to a study arm, eligible participants will be trained to perform subcutaneous injections and instructed to walk at least three times a day until they develop claudication or symptomatic limitation for 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sargramostim

FDA approved

0 / 15Eligibility criteria met