Safety, Feasibility, Efficacy of Olfactory cell transplantation therapy combined with intensive exercise rehabilitation to repair chronic traumatic spinal cord injury.
- Conditions
- Spinal Cord InjuryNeurological - Other neurological disordersPhysical Medicine / Rehabilitation - Other physical medicine / rehabilitation
- Registration Number
- ACTRN12624000391572
- Lead Sponsor
- Griffith University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method