Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

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).

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Key information

Conditions

Cervical Spinal Cord Injury Back Injuries Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Trauma Spinal Injuries Spine Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Univ. of California at San Diego, La Jolla, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AST-OPC1

Biological

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 outcomes

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

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

Lineage Cell Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Nov 26, 2014
Registry last updated: Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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