NCT01310114

Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Ischemic Stroke

A Phase 2A, Prospective, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults Following Ischemic Stroke

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Celularity Incorporated · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the safety and tolerability of Human Placenta-Derived Cells (PDA001) at 3 different dose levels versus placebo (vehicle control) administered intravenously in subjects following ischemic stroke. The secondary objective of the study is to assess the effect of PDA001 on improvement in clinical function following ischemic stroke.

Conditions

• Stroke, Acute
• Middle Cerebral Artery Stroke
• Posterior Cerebral Artery Stroke

Interventions

Type	Name	Description
BIOLOGICAL	Human Placenta-Derived Cells PDA001- (cenplacel-L)	240 mL of intravenous infusion
DRUG	Placebo	Thawed placebo

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-03-08
• Last updated: 2018-03-01

Locations

1 site across 1 country: United States