GM-CSF for Peripheral Vascular Diseases

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Peripheral Vascular Diseases+2 More
GM-CSF - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Peripheral Vascular Diseases
  • Peripheral Arterial Disease (PAD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3

Month 9
Change in 6-minute walk distance
Erythrocyte Indices
Change in Claudication Onset Time (COT)
Change in Foot Transcutaneous Oxygen Tension (TcPO2)
Change in Peak Walking Time (PWT)
Year 1
Change in 36-item Short-Form Health Survey (SF-36) Score
Change in Walking Impairment Questionnaire (WIQ): Stair Climbing Score
Change in Walking Impairment Questionnaire (WIQ): Walking Distance Score
Change in Walking Impairment Questionnaire (WIQ): Walking Speed Score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

GM-CSF
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

176 Total Participants · 2 Treatment Groups

Primary Treatment: GM-CSF · Has Placebo Group · Phase 2

GM-CSF
Drug
Experimental Group · 1 Intervention: GM-CSF · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, month 3, month 6, month 9, follow-up years 1, 2, and 3

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,577 Previous Clinical Trials
46,968,414 Total Patients Enrolled
36 Trials studying Peripheral Vascular Diseases
57,816 Patients Enrolled for Peripheral Vascular Diseases
Emory UniversityLead Sponsor
1,502 Previous Clinical Trials
2,677,421 Total Patients Enrolled
3 Trials studying Peripheral Vascular Diseases
1,025 Patients Enrolled for Peripheral Vascular Diseases
Arshed Quyyumi, MDPrincipal InvestigatorEmory University
11 Previous Clinical Trials
2,560 Total Patients Enrolled
1 Trials studying Peripheral Vascular Diseases
159 Patients Enrolled for Peripheral Vascular Diseases

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People who are taking statins for the last three months before enrollment, unless they are intolerant to statins, are eligible for the study.
If your peak walking time on a Gardner treadmill protocol is between 1 and 12 minutes, or less than 12 minutes on a modified Bruce protocol, then you are considered to have peak walking time on a Gardner protocol
An ankle-brachial index (ABI) of less than 0.90 at screening disqualifies a person from participating in the study, unless the person has an ABI of greater than 1.3 (non-compressible arteries) and a Toe-Brachial Index (TBI) of less than 0.70
Female subjects must not be pregnant, breastfeeding or of reproductive potential.
The patient has had a stable history of intermittent claudication or walking impairment for at least two months before enrollment and has not experienced any change in symptom severity in the two months prior to screening.
They need to have been on appropriate and stable medical therapy for atherosclerosis for at least 2 months prior to enrollment.
People with diabetes who haven't had a dilated eye exam in the past 12 months that excluded proliferative retinopathy are eligible to enroll.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.