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.
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.
- Ischemic Stroke
- Stroke in MCA
- Nonlacunar Stroke of MCA
- Stroke in Middle Cerebral Artery (MCA)
- ALD-401 Biological
Other Names: ALDHbr cells; ALDH Bright cells; ALD-401 Intervention Desc: 3 mL ALDHbr cells isolated from autologous bone marrow given as a one-time infusion via intracarotid infusion. ARM 1: Kind: Experimental Label: ALD-401 Description: ALD-401 is derived from Autologous Bone Marrow of the Stroke Subject
- Sham Procedure Other
Intervention Desc: Sham bone marrow harvest and sham product infusion procedures. ARM 1: Kind: Experimental Label: Sham Comparitor Description: Sham Bone Marrow harvest and sham dosing procedure.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Safety of Delivery of ALD-401||1 year||Yes|
|Secondary||Efficacy of recovery of Mental and Physical Function||1 year||No|
- Aldagen Lead