Clinical trial NCT02302157: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Lineage Cell Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection
timeFrame: One Year
Secondary outcomes:
measure: 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
timeFrame: One Year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Univ. of California at San Diego
state: California
city: Los Angeles
country: United States
facility: Rancho Los Amigos/USC
state: California
city: San Jose
country: United States
facility: Stanford University/Santa Clara Valley Medical Center
state: California
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Philadelphia
country: United States
facility: Thomas Jefferson University/Magee Rehabilitation
state: Pennsylvania
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Asterias Biotherapeutics
name: Edward D Wirth III, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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;37(3):321-330. doi: 10.3171/2021.12.SPINE21622. Print 2022 Sep 1.