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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

GPAD-3 Trial 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.Check my eligibility

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.See study design

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.

GPAD-3 Trial 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.

GPAD-3 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in 6-minute walk distance

Secondary outcome measures

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

Erythrocyte Indices

Change in Claudication Onset Time (COT)

+5 more

GPAD-3 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,851,451 Total Patients Enrolled

52 Trials studying Peripheral Arterial Disease

108,760 Patients Enrolled for Peripheral Arterial Disease

Emory UniversityLead Sponsor

1,638 Previous Clinical Trials

2,560,366 Total Patients Enrolled

3 Trials studying Peripheral Arterial Disease

1,025 Patients Enrolled for Peripheral Arterial Disease

Arshed Quyyumi, MDPrincipal InvestigatorEmory University

11 Previous Clinical Trials

2,253 Total Patients Enrolled

1 Trials studying Peripheral Arterial Disease

159 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been prior trials researching GM-CSF's effects?

"Currently, 43 ongoing clinical trials are utilizing GM-CSF with 5 of them conducting Phase 3 tests. The majority of these experiments are taking place within Seattle, WA; however, there exist 1888 sites running research involving this medication."

Answered by AI

What criteria must one meet in order to be eligible for this clinical trial?

"This clinical trial seeks 176 individuals aged between 21 and 85 years old that have peripheral vascular diseases. To qualify, participants should be on statins for the last 3 months or intolerant to them, demonstrate a Peak Walking Time (PWT) within 1-12 minutes with either Gardner treadmill or Bruce protocol; female patients must not be pregnant, breastfeeding or using inadequate contraception methods; as well as being clinically stable in terms of intermittent claudication symptoms, under appropriate medical treatment for atherosclerosis and diabetics without proliferative retinopathy."

Answered by AI

What has been the primary advantage of GM-CSF in medical treatment?

"GM-CSF can be administered to mitigate severe infection, as well as a variety of cancerous conditions such as lymphoma, hodgkins disease, bone marrow transplantation and acute myelocytic leukemia."

Answered by AI

How many individuals are taking part in the experiment?

"That is correct. According to clinicaltrials.gov, the trial posted on December 19th 2017 is still recruiting participants and has been updated as recently as October 11th 2022. 176 patients are required from a single medical centre for this study's completion."

Answered by AI

Does this trial admit individuals aged over 20 years old?

"Per the requirements of this clinical trial, only individuals aged 21 or above but below 85 are eligible to participate."

Answered by AI

How does GM-CSF affect individuals physiologically and psychologically?

"The level of security ascribed to GM-CSF is a 2, since the trial is in Phase 2 and there exists evidence that it's safe but no data yet on efficacy."

Answered by AI

Are there any remaining spots open for this research endeavor?

"Indeed, it appears that the trial is still open for enrollment. The initial posting of this study was on December 19th 2017 and the most recent update occurred on October 11th 2022. A total of 176 participants are required at one location in order to complete the research."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

Rationale and Design of the Granulocyte-macrophage Colony Stimulating Factor in Peripheral Arterial Disease (GPAD-3) Study

Mehta, Anurag, Kreton Mavromatis, Yi-An Ko, Steven C. Rogers, Devinder S. Dhindsa, Cydney Goodwin, Risha Patel, et al.. 2020. “Rationale and Design of the Granulocyte-macrophage Colony Stimulating Factor in Peripheral Arterial Disease (GPAD-3) Study”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2020.105975.

clinicaltrials.govStudy

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

Arshed A. Quyyumi 2017. "Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03304821.

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