drugset
drugset / Trial / NCT01440192

Safety of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Stage II or III Pulmonary Sarcoidosis

NCT01440192 ↗

Phase 1 Terminated 4 enrolled Celularity Incorporated
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-09
Primary completion
2014-02
Completion
2014-02

Outcome

Outcome not reported

Stopped: “Study Terminated by Sponsor”

Drugs

EvaluationDrugModalityDoseRoute
Subject PDA001 Cell therapy 2e+08 cells Intravenous

Indications

pulmonary sarcoidosis