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Stem Cell Therapy

ALD-401 for Ischemic Stroke

Phase 2
Waitlist Available
Research Sponsored by Aldagen
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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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.

Find a Location

Who is running the clinical trial?

AldagenLead Sponsor
6 Previous Clinical Trials
200 Total Patients Enrolled
James M Hinson, MDStudy DirectorAldagen

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby Mar 2025