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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is age 30 to 83 years
Has recent acute ischemic stroke in the middle cerebral artery (MCA) distribution confirmed by MRI or CT scan, with known onset time (within 24 hr)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
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.
Eligible Conditions
- Ischemic Stroke
- Stroke
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of Delivery of ALD-401
Secondary outcome measures
Efficacy of recovery of Mental and Physical Function
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALD-401Experimental Treatment1 Intervention
ALD-401 is derived from Autologous Bone Marrow of the Stroke Subject
Group II: Sham ComparitorPlacebo Group1 Intervention
Sham Bone Marrow harvest and sham dosing procedure.
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Who is running the clinical trial?
AldagenLead Sponsor
6 Previous Clinical Trials
200 Total Patients Enrolled
James M Hinson, MDStudy DirectorAldagen
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