NCT01273337

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

A Phase 2 Randomized, Controlled Study With a Phase 1 Safety Cohort Testing ALD-401 Derived From Autologous Bone Marrow Delivered Via Intracarotid Infusion in Subjects With Ischemic Stroke With Blinded Assessments

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Aldagen · Industry
• Sex: All
• Age: 30 Years – 83 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, sham-controlled, multi-center, parallel-group, study in male and female subjects, designed to determine the safety and efficacy of ALD-401 in treating primary ischemic stroke. Approximately 100 subjects will be randomized 3:2 within a site to the treatment or sham control arm. Subjects experiencing an ischemic stroke will undergo either a bone marrow or a sham harvest on days 11-17 and be dosed with ALD-401 or a sham procedure 13-19 days after the primary event. Bone marrow cells are processed, sorted and formulated into a 3 mL suspension of ALD-401. Two days after harvest, subjects in the ALD-401 group will have their processed bone marrow cells (ALD-401) injected via intracarotid/MCA infusion, while control subjects have a sham infusion. All subjects will be followed for 12 months to monitor safety and to assess mental and physical function. This study seeks to demonstrate safety of ALD-401 derived from autologous bone marrow and given via intracarotid delivery in a therapeutic window of 13-19 days post primary stroke event. This dosing window was selected to allow post-stroke inflammatory response to recede and therefore minimize the impact of resident inflammatory cells on the administration of ALD-401. This dosing window was consistent with information derived from pre-clinical models. Intracarotid/MCA delivery may offer minimal loss or dilution of therapeutic cells prior to localization in and around the ischemic area of the brain. ALD-401 will be manufactured from the patient's own bone marrow harvested 11-17 days after the primary stroke event.

Conditions

• Stroke
• Ischemic Stroke
• Stroke in Middle Cerebral Artery (MCA)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-07-01
• Completion: 2015-01-01
• First posted: 2011-01-10
• Last updated: 2014-01-16

Locations

9 sites across 1 country: United States