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| ID | Type | Description | Link |
|---|---|---|---|
| 1RC2HL101515-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Peripheral arterial disease is a common condition in older adults involving poor arterial circulation in the legs leading to leg pain and debility. The body's own circulating blood vessel stem cells may help to improve circulation. This study will test whether treatment with the drug granulocyte macrophage colony stimulating factor (GM-CSF) will improve symptoms and signs of peripheral arterial disease over placebo after four weeks of therapy. As well this study will examine whether improvements in blood vessel function can be observed. Finally, we will measure blood vessel function and stem cell levels in order to determine whether they can help to predict whether patients wither peripheral arterial disease will suffer further cardiovascular complications.
Peripheral artery disease (PAD) affects more than 8 million Americans. Although exercise, smoking cessation, anti-platelet therapy, cilostazol, statins and revascularization are used to treat PAD, men and women with PAD have significantly greater functional impairment and fasterfunctional decline than those without PAD. Stem and progenitor cell (PC) therapy that promotes neoangiogenesis is an emerging treatment modality in PAD. Progenitor cells, particularly those of endothelial origin, are involved in vascular repair and regeneration. They originate primarily but not exclusively from the bone marrow, differentiate into endothelial and other vascular cells, and contribute to neovascularization during tissue repair by direct and paracrine mechanisms. Endogenous, pharmacologically-stimulated, and exogenous PCs contribute to re-endothelialization and neovascularization. Granulocyte colony stimulating factor (G-CSF) and granulocyte-macrophage colony stimulating factor (GM-CSF) stimulate mobilization of hematopoietic and other PCs from the bone marrow.In the murine hind limb ischemia model, GM-CSF administered by injection or by plasmid transfer augments circulating levels of PCs, increases capillary density, and promotes arteriogenesis.GM-CSF also augments neo-endothelialization of denuded arteries, promotes proliferation, differentiation and survival of hematopoietic cells, monocytes and macrophages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GM-CSF | Experimental | Subjects will receive GM-CSF 500μg (Sargramostim (Leukine), Sanofi Aventis) by a self-administered subcutaneous injection thrice weekly on Monday, Wednesday, and Friday for four weeks |
|
| Placebo | Placebo Comparator | Subjects will receive a saline injection (placebo) by a self-administered subcutaneous injection thrice weekly on Monday, Wednesday, and Friday for four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granulocyte-Macrophage Stimulating Factor (GM-CSF) | Drug | 500 micrograms of GM-CSF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months | Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 6 Months | Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arshed Quyyumi, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24247554 | Derived | Poole J, Mavromatis K, Binongo JN, Khan A, Li Q, Khayata M, Rocco E, Topel M, Zhang X, Brown C, Corriere MA, Murrow J, Sher S, Clement S, Ashraf K, Rashed A, Kabbany T, Neuman R, Morris A, Ali A, Hayek S, Oshinski J, Yoon YS, Waller EK, Quyyumi AA. Effect of progenitor cell mobilization with granulocyte-macrophage colony-stimulating factor in patients with peripheral artery disease: a randomized clinical trial. JAMA. 2013 Dec 25;310(24):2631-9. doi: 10.1001/jama.2013.282540. |
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Between January 2010 and July 2012, 322 individuals with peripheral artery disease were assessed for eligibility. 159 subjects were enrolled into the study from Emory Healthcare, Veterans Affairs hospitals in Atlanta, and Medical College of Georgia.
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| ID | Title | Description |
|---|---|---|
| FG000 | GM-CSF | Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks 500 microgram dose of GM-CSF |
| FG001 | Placebo | Saline injection - three times for four weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GM-CSF | Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks 500 microgram dose of GM-CSF |
| BG001 | Placebo | Saline injection - three times for four weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months | Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis. | Posted | Mean | 95% Confidence Interval | seconds | Baseline, 3 months |
|
Adverse events were collected at weeks 1, 2, 3, 4, 8 and 3 month follow-up and 6 month follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GM-CSF | Granulocyte-Macrophage Colony Stimulating Factor injection - Monday, Wednesday and Friday for 4 weeks of therapy. 500 microgram dose of GM-CSF |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Social circumstances |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | Nervous system disorders |
Study population were subjects with claudication who underwent angiography. Study design could not show therapeutic benefit of GM-CSF therapy with dose and duration changes. And study design encouraged all subjects to walk to claudication daily.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arshed Quyyumi | Emory University School of Medicine | 4047273655 | aquyyum@emory.edu |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| C081222 | sargramostim |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Placebo | Drug | Saline injection |
|
| Baseline, 6 months |
| Change in Claudication Onset Time (COT) From Baseline to 3 Months | Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill. | Baseline, 3 months |
| Change in Claudication Onset Time (COT) From Baseline to 6 Months | Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill. | Baseline, 6 months |
| Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance. | Baseline, 3 months |
| Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance. | Baseline, 6 months |
| Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed. | Baseline, 3 months |
| Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed. | Baseline, 6 months |
| Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements. | Baseline, 3 months |
| Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements. | Baseline, 6 months |
| Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months | The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance. | Baseline, 3 months |
| Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months | The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance. | Baseline, 6 months |
| Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months | The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance. | Baseline, 3 months |
| Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months | The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance. | Baseline, 6 months |
| Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months | The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance. | Baseline, 3 months |
| Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months | The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance. | Baseline, 6 months |
| Death |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 6 Months | Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis. | Posted | Mean | 95% Confidence Interval | seconds | Baseline, 6 months |
|
|
|
| Secondary | Change in Claudication Onset Time (COT) From Baseline to 3 Months | Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill. | Posted | Mean | 95% Confidence Interval | seconds | Baseline, 3 months |
|
|
|
| Secondary | Change in Claudication Onset Time (COT) From Baseline to 6 Months | Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill. | Posted | Mean | 95% Confidence Interval | seconds | Baseline, 6 months |
|
|
|
| Secondary | Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 3 months |
|
|
|
| Secondary | Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 6 months |
|
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| Secondary | Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 3 months |
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| Secondary | Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 6 months |
|
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| Secondary | Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 3 months |
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|
| Secondary | Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months | The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 6 months |
|
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|
| Secondary | Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months | The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 3 months |
|
|
|
| Secondary | Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months | The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 6 months |
|
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| Secondary | Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months | The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 3 months |
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| Secondary | Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months | The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 6 months |
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| Secondary | Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months | The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 3 months |
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| Secondary | Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months | The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 6 months |
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|
|
| 9 |
| 80 |
| 79 |
| 80 |
| EG001 | Placebo | Saline injection - Monday, Wednesday and Friday for 4 weeks. | 9 | 79 | 69 | 79 |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Esophageal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Abdominal Pain | Gastrointestinal disorders |
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| Chest pain, non-cardiac | Musculoskeletal and connective tissue disorders |
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| Critical Limb Ischemia | Vascular disorders |
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| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders |
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| Elective Procedure | Surgical and medical procedures | Admission for elective procedure |
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| Heart Failure | Cardiac disorders |
|
| Stroke | Nervous system disorders |
|
| Small Bowel Obstruction | Gastrointestinal disorders |
|
| Trauma | Musculoskeletal and connective tissue disorders | Admission for trauma |
|
| Difficulty breathing | Cardiac disorders |
|
| Chest pain | Cardiac disorders |
|
| Joint/back/muscle pain | Musculoskeletal and connective tissue disorders |
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| Gastrointestinal side effects | Gastrointestinal disorders |
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| Night sweats | General disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Swelling | Musculoskeletal and connective tissue disorders |
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| Fatigue | General disorders |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |