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Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

L

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)

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

Trial documents
2

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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