Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02302157|
Recruitment Status : Completed
First Posted : November 26, 2014
Results First Posted : July 13, 2021
Last Update Posted : July 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cervical Spinal Cord Injury Spine Injury Spinal Cord Trauma||Biological: AST-OPC1||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
Open label, dose escalation, cross-sequential cohort of subjects who receive an injection or two injections of AST-OPC1 at a single time-point
One injection of 2 million or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent
- Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection [ Time Frame: One Year ]Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection
- Neurological Function as Measured by Upper Extremity Motor Scores and Motor Level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examinations as Secondary End Point - 365 Days After Injection of AST-OPC1 [ Time Frame: One Year ]
The scale is based on the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) that measures the severity of Spinal cord injury. The data was collected per time point during the first year (30,60,90,180,270,365). The 365-days time point was pre-specified as Secondary Outcome Measure. High score means better outcome. Units are "Scores on a scale".
The score is divided to motor scale (0-100) and sensor scale (0-224).
Motor scale is divided to subscale of upper extremity (0-50) and lower extremity (0-50).
Upper and lower extremity are divided to subscale of Right (0-25) + Left (0-25).
Each upper & lower extremity is divided to subscale of 5 motor nerve function (0-5).
Sensor scale is divided to subscale of light touch (0-112) and pin prick (0-112).
light touch and pin prick are divided to subscales of Right (0-56) + Left (0-56).
Each right and left light touch and pin prick are divided to subscales of 28 sensor nerve function (0-2)
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): NCT02302157
|United States, California|
|Univ. of California at San Diego|
|La Jolla, California, United States, 92093|
|Rancho Los Amigos/USC|
|Los Angeles, California, United States|
|Stanford University/Santa Clara Valley Medical Center|
|San Jose, California, United States, 95128|
|United States, Georgia|
|Atlanta, Georgia, United States, 30309|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, Pennsylvania|
|Thomas Jefferson University/Magee Rehabilitation|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Study Director:||Edward D Wirth III, MD, PhD||Asterias Biotherapeutics|