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

NCT01310114 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-03-01

No results posted yet for this study

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

BIOLOGICAL

Human Placenta-Derived Cells PDA001- (cenplacel-L)

240 mL of intravenous infusion

DRUG

Placebo

Thawed placebo

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Celularity Incorporated

    lead INDUSTRY

Principal Investigators

  • Monica E Luchi, MD · Celularity Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01310114 on ClinicalTrials.gov