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Study of ALD-401 Via Intracarotid Infusion in Ischemic Stroke Subjects

NCT01273337 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-01-16

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the safety of the delivery of ALD-401 by intracarotid infusion and to assess efficacy of treatment in subjects who have had unilateral, predominately cortical, ischemic strokes in the middle cerebral artery (MCA). ALD-401 is made from the stroke patient's bone marrow and infused 13-19 days after the stroke.

Conditions

Interventions

BIOLOGICAL

ALD-401

3 mL ALDHbr cells isolated from autologous bone marrow given as a one-time infusion via intracarotid infusion.

PROCEDURE

Sham Procedure

Sham bone marrow harvest and sham product infusion procedures.

Sponsors & Collaborators

  • Aldagen

    lead INDUSTRY

Principal Investigators

  • James M Hinson, MD · Aldagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
83 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-07-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01273337 on ClinicalTrials.gov