This is a randomised, blinded and controlled Phase I trial to measure the safety, feasibility and efficacy of a combined cell transplantation and intensive rehabilitation intervention to treat spinal cord injury. The trial aims to examine whether transplantation of olfactory cell nerve bridges combined with intensive rehabilitation is safe and feasible for people living with chronic spinal cord injury in Australia, and whether the intervention improves structural integrity of the spinal cord, functional recovery, overall health, and social wellbeing. For the olfactory cell nerve bridge transplant, cells from inside the patient's own nose will be purified and engrafted as 3D cellular nerve bridges. Participants will receive a dose that is dependent on the size of the accessible space within the injury site of the spinal cord with up to 60 million cells being engrafted. The surgery for the transplantation will be performed by a neurosurgeon in which the spinal cord will be exposed to enable the nerve bridges to be placed into the injury site. The duration of the procedure will be 3-4 hours. Surgical notes will be used to monitor adherence to the protocol. For intensive exercise rehabilitation, the intervention will be supervised and provided by physiotherapists and exercise physiologists at a for-purpose neurorehabilitation facility. The mode of administration will be one-on-one sessions. The 12- and 32-week rehabilitation programs will consist of up to 3 hours per day at the rehabilitation service providers, for 5 days per week. Participants will attend the provider that is within their geographical area. Over each week, sessions will involve a range and mix of activities which could include, but are not limited to, standing, gait training, upper limb strength, trunk stability/core strength, and aerobic training. Throughout the trial, logs of exercise activities will be completed by the participants and staff at the neurorehabilitation gyms. Rehabilitation will start from day 1 of the priming rehabilitation (PR) program and go for 12 weeks, then surgery and cell transplantation will occur at week 1 of the cell transplantation surgery and recover program which is 2 weeks post conclusion of Priming Rehabilitation (PR), followed by 5 weeks of recovery. Rehabilitation is for 32 weeks starting 6 weeks post transplant surgery. Regenerative rehabilitation program is from weeks 1-32 of the regenerative rehabilitation (RR) program. If nerve bridge production fails for whatever reason in the weeks prior to surgery, this will start an extension/contingency/alternative timeline, where a new nasal biopsy will need to be taken from the participant (along with accompanying tests). The cells will be grown up over the next 4 weeks with an additional week of nerve bridge production, while the participant engages in a further five weeks of priming rehabilitation.
Age range
18 Years
Sex
ALL
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Recruitment feasibility. Feasibility of delivering a cell therapy intervention and associated rehabilitation program in terms of recruitment rate - i.e. willingness of participants to complete the full program. This is a composite primary outcome.
Timeframe: 3 weeks after completion of full intervention (Regenerative Rehab (RR) week 32 of Regenerative Rehabilitation Program) i.e. at RR week 35 (post commencement of Regenerative Rehabilitation Program)
Safety Ratings. This Outcome and assessment is of safety in general, so it encompasses all AEs and SAEs and so is a composite primary outcome.
Timeframe: 3 weeks after completion of full intervention (Regenerative Rehab (RR) week 32 of Regenerative Rehabilitation Program) i.e. at RR week 35 (post commencement of Regenerative Rehabilitation Program)
Safety of transplantation: measured by adverse anatomical changes to the injury/transplant site using quantitative MRI measures.
Timeframe: MRI/FA-DTI measured at week 0 (the week prior to start of priming rehab (PR)), week 13 of PR, at week 0 of regenerative rehab (RR), RR week 7, RR week 20, RR week 33.