Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

Lineage Cell Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Spinal Cord Trauma; Spine Injury; Cervical Spinal Cord Injury

Treatments: Biological: AST-OPC1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02302157

AST-OPC1-01

Details and patient eligibility

About

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).

Enrollment: 25 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

AST-OPC1

Experimental group

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

Treatment:

Biological: AST-OPC1