Clinical Trial: Safety of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Stage II or III Pulmonary Sarcoidosis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 1B, Multi-Center, Open-Label, Single Dose Study to Evaluate the Safety of Intravenous Infusion of Human Placental-Derived Cells (PDA001) for the Treatment of Adults With Stage II or III
Brief Summary: 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.
Detailed Summary:
Sponsor: Celgene Corporation
Current Primary Outcome:
- Evaluate pulmonary artery pressure during infusion [ Time Frame: Day 1 ]Evaluate pulmonary artery pressure during infusion
- Adverse Events [ Time Frame: 24 months ( 2 years) from first dose - Study Day 1 ]Number of Participants experiencing adverse events during the initial and extended follow-up periods
- Evaluate pulse oximetry during infusion [ Time Frame: Day 1 and Day 8 ]Evaluate pulse oximetry during infusion on Day 1 and on Day 8.
Original Primary Outcome: Rise in pulmonary artery pressure mean of ≥ 10 points [ Time Frame: Pre-dose and Post-dose on Day 1 ]
Current Secondary Outcome:
- 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 vital capacity (FVC)
- 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 forced expiratory volume (FEV1)
- 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 diffusing capacity of the lung for carbon monoxide (DLCO)
- 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 ]Change from baseline thru study day 731 in 6 minute walk test (6MWT)
- 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 St. George's Respiratory Questionnaire (SGRQ).
- 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 Fatigue Assessment Score (FAS)
- 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 ]Change from baseline thru study day 731 in baseline dyspnea index (BDI)/ transitional dyspnea index (TBI
Original Secondary Outcome:
- ≥15% drop in oximetry from Day 1 or Day 8 pre-infusion value (after correction with supplemental oxygen) [ Time Frame: Pre-dose and Post-dose on Days 1 and 8 ]
- Fever of ≥ 102 F [ Time Frame: 8 days ]
- Rise in pulse of ≥ 100% or to an absolute value of 140 (whichever is lower) [ Time Frame: Pre-dose and Post-dose on Days 1 and 8 ]
- Rise in systemic diastolic pressure of ≥ 20 mm Hg or to an absolute value of 120 [ Time Frame: Pre-dose and Post-dose on Days 1 and 8 ]
Information By: Celgene
Dates:
Date Received: September 19, 2011
Date Started: September 2011
Date Completion:
Last Updated: July 14, 2014
Last Verified: July 2014