Dose Escalation and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis
|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|
Show Detailed Description
|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.
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|