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Stem Cell Therapy
Dose Escalation and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis
Phase 2
Waitlist Available
Research Sponsored by Neuralstem Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be followed postoperatively for 24 months.
Awards & highlights
No Placebo-Only Group
Summary
The study is to determine the feasibility, safety, toxicity, and maximum tolerated (safe) dose of human spinal derived neural stem cell transplantation for the treatment of Amyotrophic Lateral Sclerosis (ALS).
Eligible Conditions
- Amyotrophic Lateral Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will be followed postoperatively for 24 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed postoperatively for 24 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine the safety of the maximum tolerated dose of human spinal cord-derived neural stem cell transplantation for the treatment of amyotrophic lateral sclerosis (ALS) assessed by the number and severity of adverse events.
Secondary study objectives
To evaluate neurologic deficits post spinal stem cell transplantation therapy.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SurgeryExperimental Treatment1 Intervention
There will be 5 sequential cohorts (Groups A-E) with 3 subjects in each cohort. Each cohort will follow a dose escalation plan. New patients will be enrolled into each group. No control group is included. All patients will received spinal cord injections of HSSC.
Find a Location
Who is running the clinical trial?
Neuralstem Inc.Lead Sponsor
6 Previous Clinical Trials
527 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
18 Patients Enrolled for Amyotrophic Lateral Sclerosis