None listed
Conditions
Brief summary
Our extensive pre-clinical studies have indicated that intravenous immunoglobulin (IVIg) therapy is highly beneficial and significantly improves the neurological recovery if administered during the acute phase of SCI. As IVIg is already in clinical use as an immunomodulatory treatment for a variety of other disorders (incl. neurological conditions) and has a good safety profile, we now wish to explore the feasibility of treating human patients that have suffered either a cervical or thoracic spinal cord injury with IVIg. The specific aims of our Phase 1 study are as follows: 1) To test the feasibility of delivering IVIg within 12 hours of acute traumatic SCI. 2) To obtain data on the safety of IVIg in SCI using registry data for comparison. 3) To study the pharmacokinetics of IVIg in SCI 4) To relate the pharmacology of IVIg in SCI to safety and outcome measures 5) To obtain exploratory pilot data on the effect of IVIg treatment on the neurological outcome. Blood samples will be used for assessment of biomarkers of injury (e.g. cytokines) and studies on the pharmacological properties (e.g. half-life) of IVIg in the context of SCI. Serious adverse events will be recorded and compared to registry data / untreated patients to explore a possible (though unexpected) relationship with IVIg treatment. Suitable controls will be identified based on age, gender, nature and level of injury. De-identified data on the functional outcome of these individuals will also be used to obtain exploratory pilot data on therapeutic efficacy of IVIg. All participants will be followed for up to a year after their injury at set intervals, using physical examination to accurately determine motor and sensory recovery and questionnaires which would indicate functionality and social and emotional states.
Interventions
Privigen, i.e. liquid human Immunoglobulin preparation (10% w/v), will be administered intravenously in two doses. The first dose will be given within 12 hours of acute traumatic cervical or thoracic spinal cord injury. The second dose will be administered the following day. Each dose will be calculated to 1g/kg of the patient's body weight.
Sponsors
University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Acute traumatic cervical or thoracic spinal cord injury (up to T9). Initiation of IVIg treatment must be within 12 hours of injury.
Exclusion criteria
1. Known hypersensitivity to Privigen 2. History of significant cardiovascular, liver or kidney disease 3. Unconscious 4. Penetrating spinal cord injury 5. Involvement in another SCI research project 6. Presence of a mental disorder or other illness, which, in the view of the Principle Investigator (or their delegate) precludes informed consent and/or accurate medical evaluation. 7. Patients with history of regular substance abuse 8. Inability to commit or be available for follow-ups.
Outcome results
None listed