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Trial registered on ANZCTR
Registration number
ACTRN12624000391572
Ethics application status
Approved
Date submitted
15/01/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Safety, Feasibility, Efficacy of Olfactory cell transplantation therapy combined with intensive exercise rehabilitation to repair chronic traumatic spinal cord injury.
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Scientific title
Safety, Feasibility, Efficacy of Olfactory cell transplantation therapy combined with intensive exercise rehabilitation to repair chronic spinal cord injury in participants with traumatic spinal cord injury.
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Secondary ID [1]
311326
0
GUSIP03
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Universal Trial Number (UTN)
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Trial acronym
Griffith University Spinal Injury Project 03 (GUSIP03)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury
332578
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Condition category
Condition code
Neurological
329276
329276
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0
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Other neurological disorders
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Physical Medicine / Rehabilitation
329277
329277
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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).
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Intervention code [1]
327768
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Treatment: Other
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Intervention code [2]
327769
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Treatment: Surgery
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Intervention code [3]
328012
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Rehabilitation
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Comparator / control treatment
The control group will receive the same high-intensity rehabilitation program as the intervention group. The control group will not receive the olfactory cell nerve bridge transplant.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Reporting the number of days needed to recruit the participants for the study.
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Timepoint [1]
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2 weeks after completion of full intervention (week 48) at week 50
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Primary outcome [2]
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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.
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Assessment method [2]
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Assessed by incidence of adverse events (AE) and/or severe adverse events (SAE).
AE definition:
• An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
• NOTE: An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.
Events meeting the AE definition:
• Any abnormal laboratory test results (haematology, clinical chemistry, or urinalysis) or other safety assessments (e.g. ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the investigator (i.e., not related to progression of underlying disease)
• Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition
• New condition detected or diagnosed after study intervention administration even though it may have been present before the start of the study
• Signs, symptoms, or the clinical sequelae of a suspected intervention-intervention interaction
Events NOT meeting the definition of an AE:
• Any clinically significant abnormal laboratory findings or other abnormal safety assessments that are associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant’s condition
• The disease/disorder being studied or expected progression, signs, or symptoms of the disease/disorder being studied, unless more severe than expected for the participant’s condition
• Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition that leads to the procedure is the AE
• Situations in which an untoward medical occurrence did not occur (social and/or convenience admission to a hospital)
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of the study that do not worsen.
Assessment of AEs
• AEs will be assessed by the investigator (it is their responsibility) by reviewing all documentation (e.g. hospital progress notes, laboratory reports, and diagnostics reports) related to the event.
• The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or other clinical information. Whenever possible, the diagnosis (not the individual signs/symptoms) will be documented as the AE/SAE.
The 'Safety Ratings' outcome is an assessment of safety in general, so it encompasses all AEs and SAEs so it is a composite primary outcome.
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Timepoint [2]
337096
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Assessed 2 weeks after completion of full intervention (week 48) at week 50.
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Primary outcome [3]
337097
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Efficacy
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Assessment method [3]
337097
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assessment of repair of the injury site by measuring anatomical changes to the injury site, tractography, spinal cord axonal tracts, and neurological function, via magnetic resonance imaging (MRI), diffusion tensor imaging (DTI) and functional MRI (fMRI). All measures will be assessed as a composite primary outcome – anatomical changes to the injury site.
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Timepoint [3]
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CT/MRI/FA-DTI and fMRI measured at screening (before intervention), Week 12 of priming rehabilitation program, Week 17 (post cell transplant surgery and recovery/beginning of regenerative rehabilitation program and again at week 25, week 37 and week 48 post-commencement of intervention.
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Secondary outcome [1]
430682
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Changes in the neurological classification of SCI and sensory function:
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Assessment method [1]
430682
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tested using the International Standards for the Neurological Classification of Spinal Cord Injury instrument (ISNCSCI)
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Timepoint [1]
430682
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Outcome measured at screening, then week 12, week 17, week 29, 41 and week 48 post-commencement of intervention
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Secondary outcome [2]
430683
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Changes in electrophysiological assessments - somatosensory evoked potentials (SSEP)
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Assessment method [2]
430683
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Somatosensory evoked potentials (SSEP). SSEP measures electrical signals going from the body to the brain and helps understand sensory information like pain, temperature and touch. This test provides an understanding of a participant's neurological function.
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Timepoint [2]
430683
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Outcome measured at screening, then after intervention commencement at week 12, week 13 (SSEP during transplantation surgery), week 17, week 50 (post-rehab follow up).
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Secondary outcome [3]
430684
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Changes in biomarkers (CSF): Thousands of protein biomarkers will be assessed from the one sample. Examples of biomarkers of interest include markers for inflammation and neural injury.
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Assessment method [3]
430684
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Lumbar puncture and Cerebrospinal fluid (CSF) analysis. CSF will be analysed for approximately 7000 proteins using SomaScan Assay. Of particular interest are CXCL10, GFAP, IL 10, IL 6, IL 8, IL-1b, MCP-1 (CCLS2), MMP 8, MMP 9, NOX, NSE, PDGF AA, S100beta, Tau, TNF alpha, ULC-H1, CCL4, CD95L, CRP, Cystatin C, HMGB1, IGF-1, MiR-34a, MMP 9 , NF-H, NF-L, NOGO A, TGF-1b - these biomarkers cover areas of inflammation and neural injury amongst others.
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Timepoint [3]
430684
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Outcome measured at screening, then week 16 and week 18 post-commencement of intervention.
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Secondary outcome [4]
430685
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Changes in biomarkers (Serum). Thousands of protein biomarkers will be assessed from the one sample. Examples of biomarkers of interest include markers for inflammation and neural injury.
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Assessment method [4]
430685
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Blood tests to analyse serum-based biomarkers - Serum will be analysed for approximately 7000 proteins using SomaScan Assay. Of particular interest are CXCL10, GFAP, IL 10, IL 6, IL 8, IL-1b, MCP-1 (CCLS2), MMP 8, MMP 9, NOX, NSE, PDGF AA, S100beta, Tau, TNF alpha, ULC-H1, CCL4, CD95L, CRP, Cystatin C, HMGB1, IGF-1, MiR-34a, MMP 9 , NF-H, NF-L, NOGO A, TGF-1b - these biomarkers cover areas of inflammation and neural injury amongst others.
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Timepoint [4]
430685
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Outcome measured at screening, then week 12, week 15, week 17, week 33, week 48 post-commencement of intervention.
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Secondary outcome [5]
430689
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Changes in vital signs (Body temperature, blood pressure, heart rate, respiratory rate, oxygen saturation, electrical activity of the heart). All vital signs will be assessed as a composite secondary outcome.
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Assessment method [5]
430689
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Vital signs measured by - Body temperature (thermometer), blood pressure (sphygmomanometer), heart rate (heart rate monitor), respiratory rate (counting the number of breaths for one minute by counting how many times the chest rises), oxygen saturation (pulse oximeter). electrical activity of the heart (electrocardiogram)
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Timepoint [5]
430689
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Outcome measured at screening, then week 1, week 7, week 12, week 17 and week 48 (post-intervention commencement). ECG monitoring will be done on week 12 as a pre-operative check up.
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Secondary outcome [6]
430690
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pulmonary function (FEV1, FVC and FEV1/FVC ratio)
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Assessment method [6]
430690
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Spirometry assessment using measures of FEV1, FVC and FEV1/FVC ratio.
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Timepoint [6]
430690
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Outcome measured at screening, week 1, week 7, week 12, week 17, week 29, week 48 post-commencement of intervention
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Secondary outcome [7]
430691
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Bone Mineral Density
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Assessment method [7]
430691
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central dual energy x-ray absorptiometry (DXA or DEXA)
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Timepoint [7]
430691
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Outcome measured at screening, then week 12, week 17, week 29, week 48 post-commencement of intervention
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Secondary outcome [8]
430692
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Blood and serum tests: Full Blood Count Testing
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Assessment method [8]
430692
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Blood and serum tests: Full Blood Count Testing [WBC (WCC), RBC (RCC), Haemoglobin (Hgb or Hb), Hematocrit (Hct), Mean corpuscular volume (MCV), Mean corpuscular haemoglobin (MCH), Mean corpuscular haemoglobin concentration (MCHC), Platelets (plats), Reticulocytes (Retics), Neutrophiles (Neuts), Lymphocytes (Lymphs), Monocytes (Monos), Eosinophils (Eos), Basophils (Baso)],
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Timepoint [8]
430692
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48, post commencement of intervention.
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Secondary outcome [9]
430694
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Changes in motor function
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Assessment method [9]
430694
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using motor testing evaluation, which includes manual muscle testing, motor development scale, 6-minute walk/push test, and modified functional reach test. All measures tested together as part of this test and is used to assess the current motor function of the participant and observe changes in a process called Motor Testing Evaluation.
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Timepoint [9]
430694
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48, post commencement of intervention.
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Secondary outcome [10]
430695
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Changes in strength
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Assessment method [10]
430695
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5-Repetition Maximum Strength test, which includes chest press, latissimus dorsi (lat) pull down, overhead press, dip, and shrug as appropriate for the injury type. All measures will be tested together as part of the process of 'strength testing'.
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Timepoint [10]
430695
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48, post commencement of intervention.
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Secondary outcome [11]
430696
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Changes in pain
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Assessment method [11]
430696
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Tested using the Brief Pain Inventory
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Timepoint [11]
430696
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Outcome measured at Screening, week 1, week 7, week 12, week 17, week 29, week 41, week 48 post commencement of intervention
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Secondary outcome [12]
430697
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Changes in cardiovascular function
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Assessment method [12]
430697
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the 6-Minute Graded Arm Cycle Ergometry test
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Timepoint [12]
430697
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48, post commencement of intervention.
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Secondary outcome [13]
430698
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Changes in bowel, bladder function and independence
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Assessment method [13]
430698
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Spinal Cord Independence Measure III
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Timepoint [13]
430698
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Outcome measured at Screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48 post commencement of intervention
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Secondary outcome [14]
430699
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Changes in fatigue
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Assessment method [14]
430699
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the Fatigue Severity Scale,
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Timepoint [14]
430699
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Outcome measured at Screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48 post commencement of intervention, week 50 (post-rehab follow up),
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Secondary outcome [15]
430700
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Changes in Depression, Anxiety and Stress. All measures tested together as part of DASS-21 scale (Depression, Anxiety and Stress Scale - 21 Items.
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Assessment method [15]
430700
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Depression, Anxiety and Stress Scale - 21 Item. Developed in 1995 the DASS-21 scale contains 21 items in three subscales, which assess symptoms of depression (items 3, 5, 10, 13, 16, 17, 21), anxiety (items 2, 4, 7, 9, 15, 19, 20), and stress (items 1, 6, 8, 11, 12, 14, 18).
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Timepoint [15]
430700
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Outcome measured at Screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48 post commencement of intervention, week 50 (post-rehab follow up)
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Secondary outcome [16]
430701
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Changes in Quality of Life
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Assessment method [16]
430701
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Assessment of Quality of Life-8D scale
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Timepoint [16]
430701
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Outcome measured at Screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48 post commencement of intervention, week 50 (post-rehab follow up)
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Secondary outcome [17]
430703
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Quantify the severity of suicidal ideation and behavior.
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Assessment method [17]
430703
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Columbia Suicide Severity Rating Scale (C-SSRS)
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Timepoint [17]
430703
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Outcome measured at Screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48 post commencement of intervention.
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Secondary outcome [18]
430704
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Measure of muscle tone
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Assessment method [18]
430704
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Modified Ashworth Spasticity Scale
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Timepoint [18]
430704
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48 post commencement of intervention
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Secondary outcome [19]
430705
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Changes in lived experience
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Assessment method [19]
430705
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Pre- and post-intervention interviews of the participants will assess acceptability of intervention, facilitators and barriers to treatment/efficacy
The interviews will be semi-structured, one-on-one face-to-face (in person or virtually by video call interview with a member of the research team
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Timepoint [19]
430705
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Outcome measured at week 1, week 12, week 17, week 50 post commencement of intervention.
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Secondary outcome [20]
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Additional Primary Outcome (4): Feasibility of Surgical transplantation of nerve bridges.
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Assessment method [20]
431816
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Feasibility of transplantation is assessed by medical surgical notes. These are comprehensive notes that report the surgical procedure and will detail the success or difficulties of the procedure.
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Timepoint [20]
431816
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2 weeks after completion of full intervention (week 48) at week 50
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Secondary outcome [21]
431817
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Additional Primary Outcome (5): Feasibility of delivery of rehabilitation and assessments.
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Assessment method [21]
431817
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Feasibility of collecting outcome assessment data. Method of assessment: count the total number of
completed surveys and assessments during the trial, compared to what was assigned to be completed
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Timepoint [21]
431817
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2 weeks after completion of full intervention (week 48) at week 50
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Secondary outcome [22]
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Changes in electrophysiological assessments - Motor Evoked Potentials (MEP)
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Assessment method [22]
433023
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Motor Evoked Potentials (MEP) - MEP is a test of electrical activity of the motor pathway. This test provides an understanding of a participant's neurological function.
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Timepoint [22]
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Outcome measured at screening, then after intervention commencement at week 12, week 13 (MEP during transplantation surgery), week 17, week 50 (post-rehab follow up).
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Secondary outcome [23]
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Blood and serum tests: Coagulation studies
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Assessment method [23]
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Blood and serum tests for coagulation studies covering: [prothrombin time (PT), activated partial thrombin time (aPTT), International normalized ratio (INR)]
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Timepoint [23]
433066
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48, post commencement of intervention.
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Secondary outcome [24]
433067
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Blood and serum tests: Blood Sugar Tests
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Assessment method [24]
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Blood Sugar tests include: Glucose (Fasting), Haemoglobin A1c (HbA1c)
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Timepoint [24]
433067
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48, post commencement of intervention.
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Secondary outcome [25]
433068
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Blood and serum tests: Serological tests
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Assessment method [25]
433068
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Serological tests will include tests for Human immunodeficiency virus (HIV I/II), human T-lymphotropic virus (HTLV I/II), Hepatitis B Surface Antigen (HBSAg), Hepatitis C Antibody (HBCAb), Syphilis serology.
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Timepoint [25]
433068
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48, post commencement of intervention.
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Secondary outcome [26]
433069
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Blood and serum tests: Liver function tests
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Assessment method [26]
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Liver function tests include Protein total, Alkaline Phosphatase (ALP), Bilirubin (Total), Bilirubin (Direct), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT)], C-reactive protein (CRP), Erythrocyte Sedimentation Rate (ESR)
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Timepoint [26]
433069
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48, post commencement of intervention.
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Secondary outcome [27]
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Blood and serum tests: Lipid profile
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Assessment method [27]
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Lipid profile tests include: Cholesterol Total, Cholesterol HDL, Cholesterol LDL, Triglyceride
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Timepoint [27]
433070
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48, post commencement of intervention.
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Secondary outcome [28]
433071
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Blood and serum tests: Brain natriuretic peptide (BNP)
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Assessment method [28]
433071
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Brain natriuretic peptide test is an assessment to check for heart failure and to distinguish from other conditions with similar symptoms.
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Timepoint [28]
433071
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48, post commencement of intervention.
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Secondary outcome [29]
433074
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Blood and serum tests: Chem20 panel
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Assessment method [29]
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Chem20 panel, also known as Comprehensive Metabolic Panel or Multiple Biochemical Analysis 20 is a group of 20 blood tests that provide information about your body’s metabolism, health of kidneys and liver as well as electrolyte and acid/base balance.
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Timepoint [29]
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Outcome measured at screening, then week 1, week 7, week 12, week 17, week 29, week 41, week 48, post commencement of intervention.
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Eligibility
Key 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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation will be employed as we will be enrolling people over time, so it will be stratified (ASIA A, B, C, time since injury, para, quad) and matched (as best we can). Allotment of participants into the two groups will be randomised (using a randomisation table created by computer). For example, we will enrol 3 people within the stratification that we are after, and of those three they will then be randomly assigned two to treatment, one to control.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Statistical Hypotheses
The study will assess feasibility, safety and efficacy of treating chronic spinal cord injury with a combined approach of olfactory cell nerve bridge engraftment and intensive rehabilitation.
There are no hypotheses tested regarding the amount of change in vital signs, motor function, strength, cardiovascular function, sensory function, and psychosocial health that will potentially be observed due to the nature of the study and the limited sample size.
For the purposes of analysis, the following analysis sets are defined:
Full analysis set: • All participants enrolled in the study will be included in the analyses.
Safety analysis set: • All participants who are exposed to the study intervention will be included in the analyses.
Primary Endpoint(s)/Estimand(s) Analysis
Descriptive statistics will be presented using frequencies and percentages for categorical data as well as qualitative analysis to report on open-ended questions.
Acceptability of the program will be assessed by calculating retention rate and participant compliance at the end of the rehabilitation programs (week 12 of priming rehabilitation and final week of regenerative rehabilitation). Overall retention rate for the rehabilitation only and cell+rehabilitation groups will correspond to the total number of participants who stayed for the whole program divided by the total number of participants recruited for the program and multiplied by 100
Secondary Endpoint(s) Analysis
Descriptive statistics will be presented at different timepoints (where available):
These statistics will use median, inter-quartile range, and range for continuous data. Frequencies and percentages will be presented for categorical data.
The change scores between baseline and each timepoint as well as percentage change scores (calculated as the difference between timepoints and divided by baseline value and multiplied by 100) will be calculated and reported using descriptive statistics. Change scores will also be dichotomised to evaluate how many participants increased, decreased, or stayed stable during the program, from the start to the end, for associated measures described above.
Sample Size Determination
With the aim of obtaining indications of efficacy and responders versus non-responders, thirty participants of any gender aged 18 years or over will be included in the study. 20 will be allocated to the treatment group of cell+rehabilitation and 10 to the control rehabilitation only group. Inclusion of a control group for the study has been endorsed by the Consumer Research Panel.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
15/08/2024
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Actual
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Date of last data collection
Anticipated
1/08/2028
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
26026
0
Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]
41872
0
4215 - Southport
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Funding & Sponsors
Funding source category [1]
315579
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Charities/Societies/Foundations
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Name [1]
315579
0
Perry Cross Spinal Research Foundation
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Address [1]
315579
0
Level 7, 50 Cavill Avenue, Surfers Paradise, QLD, 4217
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Country [1]
315579
0
Australia
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Funding source category [2]
315584
0
Charities/Societies/Foundations
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Name [2]
315584
0
Clem Jones Foundation
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Address [2]
315584
0
63 Wellington Rd, Woolloongabba QLD 4102
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Country [2]
315584
0
Australia
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Funding source category [3]
315866
0
University
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Name [3]
315866
0
Griffith University
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Address [3]
315866
0
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Country [3]
315866
0
Australia
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Primary sponsor type
University
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Name
Griffith University
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Address
170 Kessels Road, Nathan, 4111, Queensland
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Country
Australia
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Secondary sponsor category [1]
317680
0
None
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Name [1]
317680
0
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Address [1]
317680
0
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Country [1]
317680
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314475
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Gold Coast Hospital and Health Service HREC
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Ethics committee address [1]
314475
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Office for Research Governance and Development Level 2 Block E – Pathology and Education 1 Hospital Boulevard Southport, QLD, 4215
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Ethics committee country [1]
314475
0
Australia
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Date submitted for ethics approval [1]
314475
0
17/01/2024
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Approval date [1]
314475
0
20/03/2024
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Ethics approval number [1]
314475
0
HREC/2024/QGC/105231
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Summary
Brief summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
Please note inclusion criteria #8: Are vaccinated against COVID-19 and have had their COVID-19 booster (if eligible); and exclusion criteria #24: Are not vaccinated against COVID-19 and have not had their COVID-19 booster (if eligible).
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Contacts
Principal investigator
Name
131714
0
Dr Brent McMonagle
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Address
131714
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Gold Coast University Hospital, 1 Hospital Blvd, Southport QLD 4215
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Country
131714
0
Australia
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Phone
131714
0
+61 7 55392399
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Fax
131714
0
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Email
131714
0
[email protected]
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Contact person for public queries
Name
131715
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Dr Andrew Rayfield
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Address
131715
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Menzies Health Institute Queensland Ian O'Connor Building (G40) Room 9.61 Gold Coast Campus, Parklands Drive, Griffith University, Southport, QLD, 4222
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Country
131715
0
Australia
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Phone
131715
0
+61 756780917
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Fax
131715
0
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Email
131715
0
[email protected]
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Contact person for scientific queries
Name
131716
0
Dr Andrew Rayfield
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Address
131716
0
Menzies Health Institute Queensland Ian O'Connor Building (G40) Room 9.61 Gold Coast Campus, Parklands Drive, Griffith University, Southport, QLD, 4222
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Country
131716
0
Australia
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Phone
131716
0
+61 756780917
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Fax
131716
0
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Email
131716
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data that underlie published results, after deidentification (text, tables, figures, and appendices).
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following article publication
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Available to whom?
Researchers who provide a methodologically sound proposal.
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Available for what types of analyses?
To achieve aims in the approved proposal.
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How or where can data be obtained?
Proposals should be directed to
[email protected]
. To gain access, data requestors will need to sign a data access agreement.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21399
Study protocol
[email protected]
21400
Statistical analysis plan
[email protected]
21401
Analytic code
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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