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Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

Primary Purpose

Cervical Spinal Cord Injury, Spine Injury, Spinal Cord Trauma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AST-OPC1
Sponsored by
Lineage Cell Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spinal Cord Injury focused on measuring Cervical spinal cord injury, AST-OPC1, SCiStar, OPC1, Neural cell, Trauma spinal cord, stemcell transplant, Cervical spine injury, Paralysis, Quadriplegia, Tetraplegia, Spine injury, oligodendrocyte progenitor cell, Subacute spinal cord injury

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Major Inclusion Criteria:

  • Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3
  • Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5
  • Last fully preserved single neurological level (SNL) from C-4 to C-7
  • From 18 through 69 years of age at time of injury
  • Single spinal cord lesion on a post-stabilization magnetic resonance imaging (MRI) scan, with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring
  • Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 37 days following injury
  • Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days following SCI

Major Exclusion Criteria:

  • SCI due to penetrating trauma
  • Traumatic anatomical transection or laceration of the spinal cord based on prior surgery or MRI
  • Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations
  • Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised
  • Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
  • History of any malignancy (except non-melanoma skin cancers)
  • Pregnant or nursing women
  • Body mass index (BMI) > 35 or weight > 300 lbs.
  • Active participation in another experimental procedure/intervention

Sites / Locations

  • Univ. of California at San Diego
  • Rancho Los Amigos/USC
  • Stanford University/Santa Clara Valley Medical Center
  • Shepherd Center
  • Rush University Medical Center
  • Indiana University
  • Washington University
  • Thomas Jefferson University/Magee Rehabilitation
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AST-OPC1

Arm Description

Open label, dose escalation, cross-sequential cohort of subjects who receive an injection or two injections of AST-OPC1 at a single time-point

Outcomes

Primary Outcome Measures

Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection
Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection

Secondary Outcome Measures

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
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)

Full Information

First Posted
November 24, 2014
Last Updated
July 12, 2021
Sponsor
Lineage Cell Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02302157
Brief Title
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
Official Title
A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lineage Cell Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Cord Injury, Spine Injury, Spinal Cord Trauma
Keywords
Cervical spinal cord injury, AST-OPC1, SCiStar, OPC1, Neural cell, Trauma spinal cord, stemcell transplant, Cervical spine injury, Paralysis, Quadriplegia, Tetraplegia, Spine injury, oligodendrocyte progenitor cell, Subacute spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AST-OPC1
Arm Type
Experimental
Arm Description
Open label, dose escalation, cross-sequential cohort of subjects who receive an injection or two injections of AST-OPC1 at a single time-point
Intervention Type
Biological
Intervention Name(s)
AST-OPC1
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection
Description
Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection
Time Frame
One Year
Secondary Outcome Measure Information:
Title
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
Description
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)
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria: Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3 Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5 Last fully preserved single neurological level (SNL) from C-4 to C-7 From 18 through 69 years of age at time of injury Single spinal cord lesion on a post-stabilization magnetic resonance imaging (MRI) scan, with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 37 days following injury Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days following SCI Major Exclusion Criteria: SCI due to penetrating trauma Traumatic anatomical transection or laceration of the spinal cord based on prior surgery or MRI Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression History of any malignancy (except non-melanoma skin cancers) Pregnant or nursing women Body mass index (BMI) > 35 or weight > 300 lbs. Active participation in another experimental procedure/intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward D Wirth III, MD, PhD
Organizational Affiliation
Asterias Biotherapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Univ. of California at San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Rancho Los Amigos/USC
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Stanford University/Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Thomas Jefferson University/Magee Rehabilitation
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35901693
Citation
Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6):812-820. doi: 10.3171/2022.5.SPINE22167. Print 2022 Dec 1.
Results Reference
derived
PubMed Identifier
35364569
Citation
McKenna SL, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth E, Fessler RG. Ten-year safety of pluripotent stem cell transplantation in acute thoracic spinal cord injury. J Neurosurg Spine. 2022 Apr 1:1-10. doi: 10.3171/2021.12.SPINE21622. Online ahead of print.
Results Reference
derived

Learn more about this trial

Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

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