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Cervical Spinal Cord Injury Treatment Study

Clinical Trial Title: 
A phase 1/2a dose escalation study of AST-OPC1 in subjects with cervical sensorimotor complete spinal cord injury.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Richard G. Fessler, MD, PhD
Clinical Trial Protocol Description: 

The purpose of this study is to evaluate the safety of three sequential escalating doses of AST-OPC1 administered at a single time-point between 14 and 30 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).

Nationwide, up to 35 patients will be recruited for this study. At Rush University Medical Center we expect to recruit approximately 5 patients.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have sensorimotor complete, traumatic SCI (ASIA Impairment Scale A).
  • Have sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B).
  • Have last fully preserved single neurological level (SNL) from C-5 to C-7.
  • Be from 18 through 69 years of age at time of injury.
  • Be able to participate in an elective surgical procedure to inject AST-OPC1 14-30 days following SCI.

You will be excluded from the study if any of the following criteria apply to you:

  • Have SCI due to penetrating trauma.
  • Have traumatic anatomical transection or laceration of the spinal cord based on prior surgery or MRI.
  • Have any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations.
  • Are not able to communicate effectively with neurological examiner such that the validity of patient data could be compromised.

This is a partial list of inclusion and exclusion criteria. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Clinical Trial Area: 
Spine and Back Disorders
Contact Email: 
Contact Phone: 
(312) 563-6827
Contact Name: 
Mary Messenger