The primary objective of the study is to assess the safety and tolerability of a single dose of PDA001 (given twice) in subjects with Stage II or III Pulmonary Sarcoidosis (PS) who are refractory to one or more of the following treatments for PS: methotrexate,immunosuppressants or cytotoxic agents.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
1 unit PDA001 (approximately 200 x 106 cells) IV on Days 1 \& 8
University of Alabama, Birmingham - Division of Pulmonary, Allergy, and Critical Care Medicine
Birmingham, Alabama, United States
National Jewish Health
Denver, Colorado, United States
University of Cincinatti Medical Center
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation - Respiratory Institute
Cleveland, Ohio, United States
Evaluate pulmonary artery pressure during infusion
Evaluate pulmonary artery pressure during infusion
Time frame: Day 1
Adverse Events
Number of Participants experiencing adverse events during the initial and extended follow-up periods
Time frame: 24 months ( 2 years) from first dose - Study Day 1
Evaluate pulse oximetry during infusion
Evaluate pulse oximetry during infusion on Day 1 and on Day 8.
Time frame: Day 1 and Day 8
Change from baseline thru study day 731 in forced vital capacity (FVC)
Change from baseline thru study day 731 in forced vital capacity (FVC)
Time frame: 24 months ( 2 years) from first dose - Study Day 1
Change from baseline thru study day 731 in forced expiratory volume (FEV1)
Change from baseline thru study day 731 in forced expiratory volume (FEV1)
Time frame: 24 months ( 2 years) from first dose - Study Day 1
Change from baseline thru study day 731 in diffusing capacity of the lung for carbon monoxide (DLCO)
Change from baseline thru study day 731 in diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: 24 months ( 2 years) from first dose - Study Day 1
Change from baseline thru study day 731 in 6 minute walk test (6MWT)
Change from baseline thru study day 731 in 6 minute walk test (6MWT)
Time frame: 24 months ( 2 years) from first dose - Study Day 1
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Change from baseline thru study day 731 in St. George's Respiratory Questionnaire (SGRQ).
Change from baseline thru study day 731 in St. George's Respiratory Questionnaire (SGRQ).
Time frame: 24 months ( 2 years) from first dose - Study Day 1
Change from baseline thru study day 731 in Fatigue Assessment Score (FAS)
Change from baseline thru study day 731 in Fatigue Assessment Score (FAS)
Time frame: 24 months ( 2 years) from first dose - Study Day 1
Change from baseline thru study day 731 in baseline dyspnea index (BDI)/ transitional dyspnea index (TBI
Change from baseline thru study day 731 in baseline dyspnea index (BDI)/ transitional dyspnea index (TBI
Time frame: 24 months ( 2 years) from first dose - Study Day 1