Severe pulmonary, cardiac or other systemic disease, specifically:
Current symptomatic pulmonary embolism
Prior or concurrent pulmonary embolism
Pulmonary embolism within 30 days prior to study entry
Pulmonary embolism
Pulmonary hypertension
The patient has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that, in the Investigator's opinion, would put the patient at significant risk for pulmonary complications during the study.
Other cardiac or pulmonary disease that, at the investigator’s discretion, can impair treatment safety
Significant pulmonary disease or condition
Severe pulmonary hypertension (PHT) (on echo or right side cardiac catheterization);
Significant pulmonary disease, including pulmonary hypertension or interstitial pneumonitis
The patient has idiopathic pulmonary fibrosis (IPF) as documented in their medical history.
Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
Symptomatic pulmonary embolism within 6 months prior to study entry
Significant pulmonary disease or condition
Severe pulmonary disease (despite above oxygen saturation and DLCO) including severe and uncontrolled asthma (per 2007 National Heart, Lung, and Blood Institute [NHLBI] Guidelines for the Diagnosis and Treatment of Asthma Expert Panel Report 3), chronic obstructive pulmonary disease, and/or pulmonary hypertension (PH); a diagnosis of PH will be made by finding of mean pulmonary artery pressure (mPAP) < 25 mm Hg on right heart catherization; in patients unable and/or unwilling to undergo cardiac catheterization, patients will be excluded with the following constellation of findings based upon presumptive diagnosis of PH (positive predictive value [PPV] of 62%): TRJ velocity > 2.5 m/sec AND either N-terminal pro-brain natriuretic peptide (NT-pro-BNP) >= 160 pg/ml OR 6-minute walk distance < 333 m
Any known uncontrolled cardiovascular disease, pulmonary embolism, hypertension not adequately controlled by standard medications within 3 months prior to enrollment.
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
Severe pulmonary hypertension (PHT) (on echo or right side cardiac catheterization)
Uncontrolled, clinically significant pulmonary disease (for example, chronic obstructive pulmonary disease, pulmonary hypertension, idiopathic pulmonary fibrosis) that in the opinion of the investigator would put the participant at significant risk for pulmonary complications during the study
Significant pulmonary artery hypertension (PAH) defined as:\r\n* Peak systolic pulmonary artery pressure > 50 mmHg by resting echocardiogram will require right heart catheterization; if pulmonary artery pressure (PAP) is not evaluable on echocardiogram due to lack of a Tricuspid regurgitant jet, then normal anatomy and function as evidenced by normal right atrium and ventricle size, shape and wall thickness and septum shape must be documented to rule-out PAH; otherwise, right heart catheterization is indicated; prior history of PAH but controlled with medications will not exclude patients from the protocol; PAH is considered controlled with medications if peak systolic pulmonary artery pressure is < 45 mmHg or mean pulmonary artery pressure by right heart catheterization is < 30 mmHg at rest\r\n* Mean pulmonary artery pressure by right heart catheterization exceeding 30 mmHg at rest; if mean PAP is elevated and pulmonary vascular resistance and transpulmonary gradient are normal then the patient is eligible for the protocol\r\n* New York Heart Association (NYHA)/World Health Organization Class III or IV
Pulmonary embolism.
Pulmonary hypertension.
Presence of cavitation of central pulmonary lesion
Pulmonary conditions such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or hypersensitivity pneumonitis are excluded
Anuria, dehydration, severe pulmonary congestion or pulmonary edema or fixed low cardiac input
Treated with appropriate maximal medical therapy for pulmonary toxicity
use of systemic steroids or immunosuppressive medication Pulmonary hypertension will not be an exclusion criterion as patients with pulmonary hypertension were shown to have higher bursting pressures following PA sealing in previous studies.
No prior history of idiopathic pulmonary fibrosis
Patient has severe pulmonary, cardiac, or other systemic disease, specifically:
No cardiomegaly or bilateral pulmonary infiltrates on chest radiograph; patients may have pulmonary metastatic lesions
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: No cardiomegaly or bilateral pulmonary infiltrates on chest radiograph; patients may have pulmonary metastatic lesions
Subjects with a history of pulmonary embolism are excluded
Subjects with a history of pulmonary hypertension is excluded
Pulmonary embolism
Pulmonary conditions such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or hypersensitivity pneumonitis
Presence of leukemic or infectious pulmonary parenchymal disease
No overt cardiac, gastrointestinal, pulmonary or psychiatric disease
Has a history of blood clots, pulmonary embolism, or DVT unless controlled by anticoagulant treatment
known pneumonitis or pulmonary fibrosis with clinically significant impairment of pulmonary function
Clinically no evidence of pulmonary disease
Evidence of pulmonary insufficiency
Other cardiac or pulmonary disease that, at the investigators discretion, can impair treatment safety
Patients must have no overt cardiac, gastrointestinal, pulmonary or psychiatric disease
Chronic pulmonary aspergillosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis (ABPA).
Symptomatic pulmonary KS
Clinical evidence of pulmonary insufficiency
Patients with radiographic changes including pulmonary disease, including but not limited to: pulmonary nodules, infiltrates, pleural effusion are excluded unless cleared by pulmonary biopsy showing no evidence for pulmonary infection
No overt cardiac, gastrointestinal, pulmonary or psychiatric disease
Pulmonary hypertension moderate to severe by echocardiographic standards
Significant pulmonary disease or condition
History of pulmonary disease or abnormal pulmonary function studies
Pulmonary metastases
Pulmonary conditions such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or hypersensitivity pneumonitis
Uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease [COPD], pulmonary hypertension) that in the opinion of the investigator would put the patient at significant risk for pulmonary complications during the study
Known history of pulmonary fibrosis
Pulmonary nodules > 10 mm\r\n* Pulmonary nodules > 10 mm that have been stable for > 6 months and are not clearly metastatic disease per the treating investigator are permitted
Significant pulmonary disease, including pulmonary hypertension or interstitial pneumonitis
History of pulmonary hypertension
Pulmonary embolism
Pulmonary hypertension
History or other evidence of chronic pulmonary disease associated with functional limitation
History or other evidence of chronic pulmonary disease associated with functional limitation
Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 6 months) or neurological disorder (e.g., seizure disorder active within 6 months)
Previous history of pulmonary embolism or pulmonary embolism found on screening exam.
The patient has uncontrolled, clinically significant pulmonary disease (e.g., COPD, pulmonary hypertension) that in the opinion of the investigator would put the patient at significant risk for pulmonary complications during the study.
Pulmonary LCNEC;
Stable cardiovascular, pulmonary health status
Normal clinical assessment of pulmonary function
Any other serious cardiac illness or medical conditions such as unstable angina, pulmonary embolism, or uncontrolled hypertension.
Any other serious cardiac illness or medical conditions such as unstable angina, pulmonary embolism, or uncontrolled hypertension
Pulmonary embolism.
Pulmonary hypertension.
Pulmonary embolism within 12 months before screening
Participant has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
Uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study.
Significant pulmonary disease, including pulmonary hypertension or interstitial pneumonitis
Known history of pulmonary hypertension
Anuria, dehydration, severe pulmonary congestion or pulmonary edema or fixed low cardiac input since all are conditions for which osmotic diuresis are contraindicated and ascorbic acid has high osmolarity
Pulmonary disease including or greater than grade 2 dyspnea or laryngeal edema, grade 3 pulmonary edema or pulmonary hypertension according to CTCAE 4.03
Pulmonary hypertension
Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen
Patients with known pulmonary hypertension
Pulmonary embolism on active therapy
Patients with severe pulmonary hypertension \r\n* Tricuspid jet velocity > 2.5 m/sec
Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
Moderate or severe pulmonary hypertension defined as pulmonary artery systolic pressure (PASP) > 50mm Hg; for those patients where PASP is indeterminate, moderate to severe symptoms of pulmonary hypertension (World Health Organization functional assessment class III or IV) will be used to determine exclusion criteria
>2 unilateral pulmonary metastasis
Patients with compromised pulmonary disease.
DONOR: Significant pulmonary disease
Patients with idiopathic pulmonary fibrosis
Pulmonary:
Previous history of pulmonary embolism or pulmonary embolism found on screening exam.
Ineligible for curative pulmonary metastasectomy
Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen
Any history or signs of pulmonary lymphangitic spread;
Previous pulmonary embolism within 12 months before study entry
Known pulmonary hypertension of any severity.
Previous pulmonary embolism within 12 months prior to study entry
Prior history of pulmonary fibrosis.
Significant pulmonary compromise
Clinical Pulmonary Infection Score (CPIS) of at least 6
History of symptomatic pulmonary disease or non-malignant pulmonary disease requiring treatment.
The patient has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study.
Pulmonary: new onset hypoxia
Echocardiographic evidence of pulmonary hypertension.
Pulmonary hypertension,
No symptomatic cardiac or pulmonary disease and a performance status equal to or =< 2
Known pulmonary hypertension
Pulmonary embolism (PE) within the last 6 months prior to registration
Uncontrolled cardiac or pulmonary disease
Active or uncontrolled pulmonary disease
Acute pulmonary embolus or pulmonary infarction in the last week
Diagnosis of acute pulmonary embolism within past 2 weeks
Diagnosis of pulmonary hypertension
Participant has had pulmonary embolism or any other thrombo-embolic event within 6 months prior to study entry
Diagnosis of acute pulmonary embolism within past 2 weeks
Diagnosis of pulmonary hypertension
Patients with pulmonary edema, congestive heart failure or pulmonary embolus
severe pulmonary hypertension
Severe pulmonary hypertension
CONTROL (HEALTHY) GROUP: Severe pulmonary hypertension
Participant has ever experienced one or more hepatic decompensation events or a history of decompensated liver disease as listed below:\r\n* Clinical ascites\r\n* Variceal bleeding documented by endoscopy\r\n* Spontaneous bacterial peritonitis documented by positive culture\r\n* Hepatic encephalopathy\r\n* Hepatorenal syndrome (type 1 or 2)\r\n* Porto-pulmonary hypertension\r\n* Hepato-pulmonary hypertension\r\n* Any liver-related event which led to a hospitalization or a grade 4 event
Active pulmonary disease requiring medication to include multiple inhalers
acute pulmonary embolism or pulmonary infarction,
Patients with pulmonary hypertension or unstable cardiopulmonary conditions
Known pulmonary hypertension
Patients with pulmonary hypertension or unstable cardiopulmonary conditions
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
Patients with evidence of moderate or severe pulmonary hypertension on echocardiogram
Suspected pulmonary hypertension: additional testing required, such as echocardiogram
Moderate-to-severe pulmonary fibrosis
PATIENT: Patients with severe emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli
Patients with severe emphysema, pulmonary vasculitis, pulmonary hypertension, respiratory distress syndrome, or a history of pulmonary embolism.
Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli
Severe emphysema, pulmonary emboli, or other conditions that cause pulmonary hypertension due to compromised pulmonary-arterial vasculature
Patients who have a known cardiac shunt or pulmonary hypertension
Patients with known pulmonary hypertension
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
With significant heart or pulmonary disease.