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Stem Cell Therapy
surgery for Amyotrophic Lateral Sclerosis (ALS Trial)
Phase 1
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
Not taking riluzole (Rilutek®) or on a stable dose for ≥30 days.
Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling] and comply with the study procedures.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the ashworth spasticity scale will be administered at -3, -2, -1 months screening/presurgery and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 and 48 month follow-up/post surgery visits.
Awards & highlights
ALS Trial Summary
This is a first-in-human trial of spinal derived stem cells transplanted into the spinal cord of patients with Amyotrophic Lateral Sclerosis (ALS). The goal of the study is to see if the cells and the procedure to transplant them are safe.
Eligible Conditions
- Amyotrophic Lateral Sclerosis
ALS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowALS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the ashworth spasticity scale will be administered at -3, -2, -1 months screening/presurgery and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 and 48 month follow-up/post surgery visits.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the ashworth spasticity scale will be administered at -3, -2, -1 months screening/presurgery and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 and 48 month follow-up/post surgery visits.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary objective of this study is to determine the safety of human spinal cord-derived neural stem cell transplantation for the treatment of amyotrophic lateral sclerosis.
Secondary outcome measures
Stem cell transplant
ALS Trial Design
1Treatment groups
Experimental Treatment
Group I: surgeryExperimental Treatment1 Intervention
A sequential design of five groups will be utilized to reduce risk to subjects. The first group (Group A) will include six subjects and the subsequent groups will include three subjects per group. Each group represents both different inclusion criteria and location of surgery.
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.
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