Dose Escalation and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis
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|ClinicalTrials.gov Identifier: NCT01730716|
Recruitment Status : Unknown
Verified May 2013 by Neuralstem Inc..
Recruitment status was: Active, not recruiting
First Posted : November 21, 2012
Last Update Posted : April 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Device: Human spinal cord stem cell implantation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-label, Dose Escalation and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||November 2016|
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.
Device: Human spinal cord stem cell implantation
Human spinal cord stem cell implantation in ALS patients.
- 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. [ Time Frame: Patients will be followed postoperatively for 24 months. ]The primary objective of the study is to determine the feasibility, safety, toxicity, and maximum tolerated (safe) dose of human spinal cord-derived neural stem cell transplantation for the treatment of amyotrophic lateral sclerosis (ALS).
- To evaluate neurologic deficits post spinal stem cell transplantation therapy. [ Time Frame: Patients will be followed postoperatively for 24 months. ]The secondary objectives of the study are to evaluate spinal stem cell transplantation therapy in this patient population for: 1) attenuation of motor function loss; 2) maintenance of respiratory capacity; 3) stabilization of ALSFRS-R; 4) reduction of spasticity/rigidity if present; and 5) graft survival at autopsy if and when there is mortality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730716
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|