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Stem Cell Therapy

Surgery for 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

Study 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 weeks
Treatment ~ Varies
Follow Up ~patients will be followed postoperatively for 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed postoperatively for 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
To evaluate neurologic deficits post spinal stem cell transplantation therapy.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dose Escalation and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis
2013. "Dose Escalation and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01730716.
All > Stem Cell Transplant > Spinal Cord
~1 spots leftby May 2025
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