Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

Cervical Spinal Cord Injury Clinical Trial

Official title:

A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302157
• Other study ID #: AST-OPC1-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2015
• Est. completion date: December 2018

Study information

• Verified date: June 2021
• Source: Lineage Cell Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Spinal Cord Injuries
• Spinal Cord Trauma
• Spinal Injuries
• Spine Injury
• Wounds and Injuries

Intervention

Biological:
• AST-OPC1
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

Locations

Country	Name	City	State
United States	Shepherd Center	Atlanta	Georgia
United States	Rush University Medical Center	Chicago	Illinois
United States	Indiana University	Indianapolis	Indiana
United States	Univ. of California at San Diego	La Jolla	California
United States	Rancho Los Amigos/USC	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Thomas Jefferson University/Magee Rehabilitation	Philadelphia	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	Stanford University/Santa Clara Valley Medical Center	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Lineage Cell Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One Year
Secondary	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)	One Year