| Eligibility |
Inclusion Criteria:
A subject must provide written informed consent in accordance with local regulations prior
to initiation of any study-specific activities/procedures. A legally authorized
representative (LAR) may be used to assist in signing the informed consent.
Cervical SCI resulting from acute physical trauma.
Males and females
Age 18 - 75 years, inclusive.
Cervical SCI, incomplete, with a neurological level of injury being at C7 or higher.
Had incomplete cervical SCI within the period from 1 year to 10 years inclusive (Chronic
cohort 1) OR within 10 days to 49 days inclusive (Subacute cohort 2) at time of
randomization.
Must be able to volitionally initiate at least one step on one leg (without body weight
support).
Must have a Walking Index for Spinal Cord Injury II (WISCI II) score as follows:
1. For Chronic cohort 1: Less than or equal to Level 14.
2. For Subacute cohort 2: Less than or equal to Level 8.
GRASSP Prehension Ability score
For Chronic cohort 1:
i. Must have a score of at least 2 on at least one of the Prehension Ability grasp patterns
of the GRASSP assessment in at least one upper extremity. ii. Must have no more than one
Prehension Ability grasp patterns score = 4 in the upper extremity satisfying criterion i
For Subacute cohort 2:
i. Must have a score of 2 on at least one of the Prehension Ability grasp patterns of the
GRASSP assessment in at least one upper extremity. ii. Must have no more than one
Prehension Ability grasp patterns score = 3 in the upper extremity satisfying criterion i.
iii. Must not have a Prehension Ability grasp patterns score = 4 in the upper extremity
satisfying criterion i.
Must be fluent in English.
Subjects must be willing and able to comply with scheduled visits, all sample collections,
and other trial procedures.
Exclusion Criteria:
Nontraumatic SCI (e.g., due to infection, ischemia, metabolic abnormality, congenital
abnormality, malignancy, radiation injury, or other disease process).
Spinal cord injury due to gunshot wound or penetrating injury.
Two or more (noncontiguous) spinal cord lesions.
MRI evidence of anatomically complete spinal cord transection.
Any form of ventilatory dependence.
Any condition that precludes adequate clinical assessment of all four extremities, such as
contracture, peripheral nerve injury, amputation.
History of seizures (febrile seizures allowed).
Metal implant in the head.
History of traumatic brain injury without recovery.
Any neurological condition that may interfere with performance or confound assessment, such
as multiple sclerosis, stroke, or syringomyelia.
History of substance abuse within 12 months prior to screening, based on medical records or
self-report.
Evidence of spinal instability or persistent spinal stenosis and/or compression related to
initial trauma.
Prior treatment with cell therapy delivered into the CNS (intrathecal or intraparenchymal).
Severe neuropathic pain inadequately controlled by medication.
Body mass index (BMI) > 40 (body weight in kilograms divided by height in meters squared).
Received botulinum toxin injection(s) in an upper or lower extremity muscle in the prior 6
months.
Received 4-aminopyridine within 14 days of screening.
Prior treatment with a protein tyrosine phosphatase sigma (PTPs) mimetic peptide.
Intrathecal opioid use.
Currently participating in an interventional clinical trial.
Received a non-permitted medication within 5.5 half-lives or 7 days, whichever is longer,
prior to randomization
Receiving any treatment intended to enhance neuroplasticity (e.g., electrical stimulation,
acute intermittent hypoxia) at the time of consent to participate in this study or within 4
weeks of randomization, whichever is longer.
Any implanted internal spinal cord stimulator.
Currently receiving neuromuscular stimulation.
Currently receiving vagal nerve stimulation.
Any contraindication to undergo MRI studies such as:
1. History of a cardiac pacemaker or pacemaker wires, OR
2. Metallic particles in the body, OR
3. Baclofen pump, OR
4. Vascular clips in the head, OR
5. Prosthetic heart valves, OR
6. Severe claustrophobia impeding ability to participate in an imaging study.
Malignancy within 5 years prior to screening, except for non-melanoma skin cancers or
cervical or breast ductal carcinoma in situ.
Severe renal insufficiency, as defined by eGFR < 30 mL/min/1.73m2.
Any other social or medical condition (e.g., uncontrolled diabetes, unstable hypertension)
which, in the opinion of the investigator, would make the subject unsuitable for study
participation.
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