None listed
Conditions
Brief summary
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 well-being.
Interventions
This is a randomised, blinded and controlled Phase I/IIa 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
This is a randomised, blinded and controlled Phase I/IIa 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 of 1-2 cm in length 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 and go for 12 weeks, then surgery and cell transplantation will occur at week 13 followed by 3-4 weeks of recovery, and then rehabilitation for 32 (weeks 17-48).
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, fu
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 well-being. 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 staff at the neurorehabilitation gyms. Rehabilitation will start from day 1 and go for 12 weeks, then surgery and cell transplantation will occur post one week of rest and testing. Surgery will be followed by 4-5 weeks of recovery, and then regenerative rehabilitation will occur post a week of tests for an addition 32 weeks on-site. The program will conclude with 1 week of rest and testing, and a post-rehab follow up after a further 2 weeks.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion/exclusion criteria for participants have been determined in consultation with medical and rehabilitation specialists including a clinician with lived experience of SCI. Inclusion Criteria Participants are eligible to be included in the study only if all the following criteria apply: 1. Have sustained a traumatic spinal cord injury a minimum of 4 months prior to consent and have completed their primary rehabilitation; 2. Have a stable neurological level and functional ability of more than two months in duration; 3. Are over 18 years and able to give informed consent; 4. Are AIS A, B or low functioning C (more than 75% of key muscles have a power grade <3) as per the International Standards for Neurological Classification of spinal cord injury, and documented by an ISNCSCI/ASIA exam performed by a qualified practitioner within the last six months; 5. Have a thoracic injury or lower cervical (C5-C8) injury; 6. Are able and willing to attend an exercise program five times per week for the duration of the priming rehabilitation program, with allowance for two weeks recreational leave; 7. Are able and willing to attend an exercise program five times per week for at least 12 weeks of the regenerative rehabilitation program and then at least three days per week for the remaining 20 weeks, with allowance for four weeks recreational leave; 8. See public notes section. 9. Are considered by their general practitioner or specialist medical consultant to be fit to receive the cell transplantation and undertake the exercise program (documented approval by general practitioner required).
Exclusion criteria
Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: 1. Have a high cervical (C1-C4) injury (excluded due to respiratory risk); 2. Have significant concomitant central nervous system, peripheral nervous system or musculoskeletal system injuries or disorders limiting their ability to exercise; 3. Have had recent major trauma or surgery within the last 4 months; 4. Have an existing stage 3 or 4 pressure ulcer according to the National Pressure Ulcer Advisory Panel classification; 5. Have endocrinopathy or metabolic disorders of the bone, including but not limited to Paget’s disease, lytic or renal bone disease, and senile osteoporosis; 6. Have a medical history of exposure to medication(s) known to affect mineral or bone metabolism; 7. Have significant impairment or disability, including physical, neurological or psychological impairments, in addition to the spinal cord injury; 8. Have a history of long bone fracture incompletely healed; 9. Have extensive fixed contractures in the upper or lower limbs; 10. Have severe spasticity; 11. Have uncontrolled neuropathic pain; 12. Have autonomic dysreflexia without a management plan; 13. Do not have adequate transport options to attend the rehabilitation sessions; 14. Are unable to attend the pre-intervention assessments and the follow-up assessments; 15. Are unable to attend the surgery at GCUH (if in cell+rehabilitation group); 16. Have any contraindications to FES such as a cardiac pacemaker, epilepsy, lower limb fracture or pregnancy; 17. Have any other serious medical condition including but not limited to malignancies, auto-immune disorders (requiring continuous pharmaceutical management), psychiatric, behavioural or drug dependency problems, which are likely to influence the participant’s ability to cooperate or, in the opinion of the study investigator, would prevent adherence to the protocol; 18. Have symptomatic, radiologically demonstrated, or provocatively demonstrated ischaemic heart disease; 19. Have current thromboembolic disease; 20. Are using illicit drugs; 21. Are participating in other clinical trials (including medication, therapeutic interventions and alternative therapies) or taking medications (including herbal preparations) that are not considered to be standard care as per the protocol; 22. Are unable to tolerate expected exercise load. 23. Are unable to comply with the assessment regime (such as having claustrophobia which prevents MRI procedures being conducted); 24. See public notes section. 25. Are unable to demonstrate that they have adequate social/family/carer support at home to enable their participation throughout the trial.
Outcome results
None listed