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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Treatment group of cell transplantation and rehabilitation
control rehabilitation only group
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
4a. Changes in AIS grade
Time frame: Outcome measured at screening, then week Priming Rehabilitation (PR) week 13, Regenerative Rehab(RR) week 7, RR week 20, RR week 33 (i.e. 33 weeks post-commencement of Regenerative Rehabilitation intervention
Changes in electrophysiological assessments - somatosensory evoked potentials (SSEP)
Time frame: Outcome measured at priming rehab (PR) week 0, PR week 13, a week later at transplant week 1 (SSEP during surgery), Regenerative Rehab (RR) week 0, RR week 33)
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.
Time frame: Outcome measured at baseline (post screening), then Transplant Surgery (TS) week 4) and Regenerative Rehab (RR) week 33, i.e. 33 weeks post-commencement of Regenerative rehab intervention.
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.
Time frame: Outcome measured at baseline (post-screening), then Priming Rehabilitation (PR) week 13, Transplant Surgery (TS) week 4, Regenerative Rehab (RR) week 0, RR week 20, RR week 33 post-commencement of regenerative rehab intervention.
8a. Changes in vital signs - Body temperature. All vital signs will be assessed as a composite secondary outcome.
Time frame: 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.
Pulmonary Function (Spirometry)
9a. Forced Expiratory Volume in 1 Second * Name of Measurement: Forced expiratory volume in 1 second (FEV1) * Measurement Tool: Spirometry * Unit of Measure: Litres (L)
Time frame: Outcome measured at screening, Priming Rehabilitation (PR) week 0 (for those who have had metal work removal surgery prior), PR week 13, Regenerative Rehab (RR) week 0, RR week 33 (33 weeks post commencement of regenerative rehab) intervention
Bone Mineral Density (DEXA)
10b. T score * Name of Measurement: Bone mineral density T score * Measurement Tool: Dual energy X ray absorptiometry (DEXA) * Unit of Measure: T score (unitless)
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 13, Regenerative Rehabilitation (RR) week 33 post-commencement of Regenerative Rehab intervention
Full Blood Count (FBC)
11e. White Blood Cell Count * Name of Measurement: White blood cell count * Measurement Tool: Laboratory full blood count analysis * Unit of Measure: ×10⁹/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Motor Function
12a. Manual Muscle Testing Score * Name of Measurement: Motor function score * Measurement Tool: Injury specific motor testing evaluation * Unit of Measure: Ordinal score
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32, post commencement of Regenerative Rehab intervention.
Muscle Strength (5 RM)
13a. Upper Limb Strength * Name of Measurement: Five repetition maximum strength * Measurement Tool: 5 Repetition Maximum strength testing * Unit of Measure: Kilograms (kg)
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32, post commencement of Regenerative Rehab intervention.
Pain
14a. Pain Severity * Name of Measurement: Pain severity score * Measurement Tool: Brief Pain Inventory * Unit of Measure: Numeric scale score 14b. Pain Interference * Name of Measurement: Pain interference score * Measurement Tool: Brief Pain Inventory * Unit of Measure: Numeric scale score
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32, post commencement of Regenerative Rehab intervention.
Cardiovascular function
15a. Arm Ergometry Exercise Duration * Name of Measurement: Exercise tolerance * Measurement Tool: 6 Minute Graded Arm Cycle Ergometry Test * Unit of Measure: Minutes
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32, post commencement of Regenerative Rehab intervention
Bowel, bladder function and independence
16a. Functional Independence Score * Name of Measurement: Spinal cord independence * Measurement Tool: Spinal Cord Independence Measure - III (SCIM III) * Unit of Measure: Total score (0-100)
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32, post commencement of Regenerative Rehab intervention.
Fatigue
17a. Fatigue Severity * Name of Measurement: Fatigue severity * Measurement Tool: Fatigue Severity Scale * Unit of Measure: Total score
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR)week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32 and RR week 35 (End of Study week) i.e. post commencement of Regenerative Rehab intervention.
Depression, Anxiety and Stress
18a. Depression Score * Name of Measurement: Depression symptoms * Measurement Tool: Depression Anxiety Stress Scale - 21 items * Unit of Measure: Subscale score 18b. Anxiety Score * Name of Measurement: Anxiety symptoms * Measurement Tool: Depression Anxiety Stress Scale - 21 items * Unit of Measure: Subscale score 18c. Stress Score * Name of Measurement: Stress symptoms * Measurement Tool: Depression Anxiety Stress Scale - 21 items * Unit of Measure: Subscale score
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR)week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32 and RR week 35 (End of Study week) i.e. post commencement of Regenerative Rehab intervention.
Quality of Life
19a. Health Utility Index * Name of Measurement: Health related quality of life * Measurement Tool: Assessment of Quality of Life - 8 Dimensions (AQoL 8D) * Unit of Measure: Utility score
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32 and RR week 35 (End of Study week) i.e. post commencement of Regenerative Rehab intervention
Suicidal ideation and behaviour.
20a. Suicidality Severity * Name of Measurement: Severity of suicidal ideation and behaviour * Measurement Tool: Columbia Suicide Severity Rating Scale (C SSRS) * Unit of Measure: Ordinal severity category
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR)week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32 and RR week 35 (End of Study week) i.e. post commencement of Regenerative Rehab intervention.
Muscle tone
21a. Spasticity Severity * Name of Measurement: Muscle tone * Measurement Tool: Modified Ashworth Spasticity Scale * Unit of Measure: Ordinal score (0-4)
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32, post commencement of Regenerative Rehab intervention.
Lived experience
22a. Participant Experience Themes * Name of Measurement: Lived experience of intervention * Measurement Tool: Semi structured qualitative interviews * Unit of Measure: Qualitative thematic outcomes
Time frame: Outcome measured at baseline, Priming Rehabilitation (PR) week 13, Regenerative Rehab (RR) week 9, RR week 35 (i.e. 35 weeks post commencement of Regenerative Rehab intervention.)
Feasibility of transplantation assessed by clinician-developed questionnaire with discrete parameters and medical surgical notes. Will report success or difficulties of nerve bridge transplantation procedure.
Time frame: 3 weeks after completion of Regenerative Rehab (RR) intervention (RR week 32) at RR week 35 (Final study/End of study week).
Feasibility of delivery of rehabilitation and assessments.
24a. Assessment Completion Rate * Name of Measurement: Feasibility of intervention delivery * Measurement Tool: Study specific feasibility calculation * Unit of Measure: Percentage (%)
Time frame: 3 weeks after completion of Regenerative Rehab (RR) intervention (RR week 32) at RR week 35 (Final study/End of study week).
Changes in electrophysiological assessments - Motor Evoked Potentials (MEP)
Time frame: Outcome measured at priming rehab (PR) week 0, PR week 13, a week later at transplant week 1 (MEP during surgery), Regenerative Rehab (RR) week 0, RR week 33)
Blood and serum tests: Coagulation studies
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Blood and serum tests: Blood Sugar Tests
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Blood and serum tests: Serological tests (test for HIV I/II, HTLV I/II, HBSAg, HBCAb, Syphilis serology)
Time frame: Outcome measured at screening, again at Baseline. If nerve bridge fails an new biopsy needed, serology test again at Priming Rehab (PR) week 14, before biopsy taken.
Blood and serum tests: Liver function tests
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Blood and serum tests: Lipid profile
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Blood and serum tests: Brain natriuretic peptide (BNP)
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Blood and serum tests: Chem20 panel
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Acceptability of the program
33a. Retention Rate * Name of Measurement: Program retention * Measurement Tool: Study specific retention calculation * Unit of Measure: Percentage (%) 33b. Compliance Rate * Name of Measurement: Program compliance * Measurement Tool: Study specific compliance calculation * Unit of Measure: Percentage (%)
Time frame: At the end of the priming rehabilitation (PR) program: PR week 13 and at the final week of the regenerative rehabilitation (RR): RR week 35.
Quantitative MRI and DTI -Anatomical Repair
34a. Spinal Cord Cross Sectional Area * Name of Measurement: Spinal cord cross sectional area * Measurement Tool: Quantitative MRI * Unit of Measure: mm²
Time frame: MRI/FA-DTI measured at week 0, Priming Rehab (PR) week 13, week 0 of regenerative rehab (RR), RR week 7, RR week 20, RR week 33
Exploratory rs fMRI - Functional Connectivity
35a. Functional Connectivity Strength * Name of Measurement: Resting state functional connectivity * Measurement Tool: Resting state functional MRI * Unit of Measure: Pearson correlation coefficient (r)
Time frame: rs-fMRI measured at week 0, Priming Rehab (PR) week 13, Regenerative rehab (RR) week 0, RR week 7, RR week 20, RR week 33.
Exploratory Safety - rs fMRI Signal Stability)
36a. Temporal Signal to Noise Ratio * Name of Measurement: MRI signal stability * Measurement Tool: Resting state functional MRI * Unit of Measure: TSNR (unitless)
Time frame: rs-fMRI measured at week 0, Priming Rehab (PR) week 13, Regenerative Rehab (RR) week 0, RR week 7, RR, week 20, RR week 33.
Bladder Function
37a. Bladder Pressure * Name of Measurement: Bladder function * Measurement Tool: Urodynamic studies * Unit of Measure: cmH₂O
Time frame: Outcome measured at Baseline then Priming Rehabilitation (PR) week 13, and Regenerative Rehabilitation (RR) week 33 (i.e. 33 weeks post commencement of regenerative rehabilitation intervention.)
Changes in AIS grade, total sensory score, and total motor score
Time frame: Outcome measured at screening, then week Priming Rehabilitation (PR) week 13, Regenerative Rehab(RR) week 7, RR week 20, RR week 33 (i.e. 33 weeks post-commencement of Regenerative Rehabilitation intervention
4b. Changes in AIS total sensory score
Time frame: Outcome measured at screening, then week Priming Rehabilitation (PR) week 13, Regenerative Rehab(RR) week 7, RR week 20, RR week 33 (i.e. 33 weeks post-commencement of Regenerative Rehabilitation intervention
4c. Changes in AIS total motor score
Time frame: Outcome measured at screening, then week Priming Rehabilitation (PR) week 13, Regenerative Rehab(RR) week 7, RR week 20, RR week 33 (i.e. 33 weeks post-commencement of Regenerative Rehabilitation intervention
8b. Changes in vital signs- blood pressure. All vital signs will be assessed as a composite secondary outcome.
Time frame: 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.
8c. Changes in vital signs - heart rate. All vital signs will be assessed as a composite secondary outcome.
Time frame: 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.
8d. Changes in vital signs- respiratory rate. All vital signs will be assessed as a composite secondary outcome.
Time frame: 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.
8e. Changes in vital signs- oxygen saturation. All vital signs will be assessed as a composite secondary outcome.
Time frame: 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.
8f. Electrical Activity of the Heart (Electrocardiography)
8f- 3. PR Interval * Name of Measurement: PR interval * Measurement Tool: 12 lead electrocardiogram (ECG) * Unit of Measure: Milliseconds (ms)
Time frame: 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.
White Blood Cell Differential (Absolute Counts)
11g. Neutrophil Count * Name of Measurement: Absolute neutrophil count * Measurement Tool: Laboratory full blood count differential * Unit of Measure: ×10⁹/L 11h. Lymphocyte Count * Name of Measurement: Absolute lymphocyte count * Measurement Tool: Laboratory full blood count differential * Unit of Measure: ×10⁹/L 11i. Monocyte Count * Name of Measurement: Absolute monocyte count * Measurement Tool: Laboratory full blood count differential * Unit of Measure: ×10⁹/L 11j. Eosinophil Count * Name of Measurement: Absolute eosinophil count * Measurement Tool: Laboratory full blood count differential * Unit of Measure: ×10⁹/L 11k. Basophil Count * Name of Measurement: Absolute basophil count * Measurement Tool: Laboratory full blood count differential * Unit of Measure: ×10⁹/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Reticulocytes and Red Cell Indices
11l. Reticulocyte Count * Name of Measurement: Reticulocyte count * Measurement Tool: Laboratory hematology analysis * Unit of Measure: ×10⁹/L or %
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Inflammation Markers
11n. C Reactive Protein * Name of Measurement: C reactive protein * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: mg/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Coagulation Studies
11q. Prothrombin Time * Name of Measurement: Prothrombin time * Measurement Tool: Laboratory coagulation analysis * Unit of Measure: Seconds (s)
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Metabolic and Biochemistry Panel (E/LFT Panel - MB2)
11s. Serum Sodium * Name of Measurement: Serum sodium * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: mmol/L 11t. Serum Potassium * Name of Measurement: Serum potassium * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: mmol/L 11u. Serum Chloride * Name of Measurement: Serum chloride * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: mmol/L 11v. Serum Bicarbonate * Name of Measurement: Serum bicarbonate * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: mmol/L 11w. Serum Calcium (Corrected) * Name of Measurement: Corrected serum calcium * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: mmol/L 11x. Serum Phosphate * Name of Measurement: Serum phosphate * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: mmol/L 11y. Serum Urea * Name of Measurement: Serum urea * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: mmol/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Metabolic and Biochemistry Panel (E/LFT Panel - MB2)
11z. Serum Creatinine * Name of Measurement: Serum creatinine * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: µmol/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Liver Function Tests
11ab. Alanine Aminotransferase * Name of Measurement: Alanine aminotransferase (ALT) * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: U/L 11ac. Aspartate Aminotransferase * Name of Measurement: Aspartate aminotransferase (AST) * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: U/L 11ad. Alkaline Phosphatase * Name of Measurement: Alkaline phosphatase * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: U/L 11ae. Gamma Glutamyl Transferase * Name of Measurement: Gamma glutamyl transferase (GGT) * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: U/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Liver Function Tests
11ah. Total Protein * Name of Measurement: Serum total protein * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: g/L 11ai. Serum Albumin * Name of Measurement: Serum albumin * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: g/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Lipid Profile
11aj. Total Cholesterol * Name of Measurement: Total cholesterol * Measurement Tool: Laboratory lipid analysis * Unit of Measure: mmol/L 11ak. High Density Lipoprotein Cholesterol * Name of Measurement: HDL cholesterol * Measurement Tool: Laboratory lipid analysis * Unit of Measure: mmol/L 11al. Low Density Lipoprotein Cholesterol * Name of Measurement: LDL cholesterol * Measurement Tool: Laboratory lipid analysis * Unit of Measure: mmol/L 11am. Triglycerides * Name of Measurement: Triglycerides * Measurement Tool: Laboratory lipid analysis * Unit of Measure: mmol/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Glycaemic Markers
11an. Fasting Serum Glucose * Name of Measurement: Fasting serum glucose * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: mmol/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Cardiac Biomarker
11ap. NT proBNP * Name of Measurement: N terminal pro brain natriuretic peptide * Measurement Tool: Laboratory immunoassay * Unit of Measure: pg/mL
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Infectious Disease Serology
11aq. Hepatitis B Surface Antigen * Name of Measurement: Hepatitis B surface antigen * Measurement Tool: Laboratory serological analysis * Unit of Measure: Qualitative (positive/negative)
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Microbiological Testing
11av. Genital / Urethral Swab Culture * Name of Measurement: Microbiological culture and sensitivity * Measurement Tool: Laboratory microbiological testing * Unit of Measure: Qualitative (organism identified / sensitivity profile)
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
9. Pulmonary Function (Spirometry)
9c. FEV1/FVC Ratio * Name of Measurement: FEV1/FVC ratio * Measurement Tool: Spirometry * Unit of Measure: Ratio (unitless)
Time frame: Outcome measured at screening, Priming Rehabilitation (PR) week 0 (for those who have had metal work removal surgery prior), PR week 13, Regenerative Rehab (RR) week 0, RR week 33 (33 weeks post commencement of regenerative rehab) intervention
10. Bone Mineral Density (DEXA)
10a. Areal Bone Mineral Density * Name of Measurement: Bone mineral density * Measurement Tool: Dual energy X ray absorptiometry (DEXA) * Unit of Measure: g/cm²
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 13, Regenerative Rehabilitation (RR) week 33 post-commencement of Regenerative Rehab intervention
Full Blood Count (FBC)
11a. Hemoglobin * Name of Measurement: Hemoglobin concentration * Measurement Tool: Laboratory full blood count analysis * Unit of Measure: g/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Full Blood Count (FBC)
11b. Hematocrit * Name of Measurement: Hematocrit * Measurement Tool: Laboratory full blood count analysis * Unit of Measure: %
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Full Blood Count (FBC)
11c. Red Blood Cell Count * Name of Measurement: Red blood cell count * Measurement Tool: Laboratory full blood count analysis * Unit of Measure: ×10¹²/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Full Blood Count (FBC)
11d. Mean Corpuscular Volume * Name of Measurement: Mean corpuscular volume (MCV) * Measurement Tool: Laboratory full blood count analysis * Unit of Measure: fL
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Motor Function
12b. Six Minute Walk / Push Distance * Name of Measurement: Functional ambulation or propulsion distance * Measurement Tool: 6 Minute Walk Test or 6 Minute Push Test * Unit of Measure: Metres (m)
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32, post commencement of Regenerative Rehab intervention.
Cardiovascular function
15b. Heart Rate Response * Name of Measurement: Heart rate during exercise * Measurement Tool: Physiological monitoring during ergometry * Unit of Measure: Beats per minute (bpm)
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 1, PR week 7, PR week 12, Regenerative Rehab (RR) week 1, RR week 12, RR week 24, RR week 32, post commencement of Regenerative Rehab intervention
Quantitative MRI and DTI -Anatomical Repair
34b. Fractional Anisotropy * Name of Measurement: White matter microstructural integrity * Measurement Tool: Diffusion Tensor Imaging * Unit of Measure: Fractional anisotropy (unitless)
Time frame: MRI/FA-DTI measured at week 0, Priming Rehab (PR) week 13, week 0 of regenerative rehab (RR), RR week 7, RR week 20, RR week 33
Quantitative MRI and DTI -Anatomical Repair
34c. Mean Diffusivity * Name of Measurement: Mean diffusivity * Measurement Tool: Diffusion Tensor Imaging * Unit of Measure: mm²/s
Time frame: MRI/FA-DTI measured at week 0, Priming Rehab (PR) week 13, week 0 of regenerative rehab (RR), RR week 7, RR week 20, RR week 33
Bladder Function
37b. Bladder Volume * Name of Measurement: Bladder capacity * Measurement Tool: Urodynamic studies * Unit of Measure: Millilitres (mL)
Time frame: Outcome measured at Baseline then Priming Rehabilitation (PR) week 13, and Regenerative Rehabilitation (RR) week 33 (i.e. 33 weeks post commencement of regenerative rehabilitation intervention.)
Reticulocytes and Red Cell Indices
11m. Mean Corpuscular Hemoglobin Concentration * Name of Measurement: Mean corpuscular hemoglobin concentration (MCHC) * Measurement Tool: Laboratory hematology analysis * Unit of Measure: g/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Inflammation Markers
11o. Erythrocyte Sedimentation Rate * Name of Measurement: Erythrocyte sedimentation rate * Measurement Tool: Laboratory hematology analysis * Unit of Measure: mm/hr
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Coagulation Studies
11p. International Normalised Ratio * Name of Measurement: International normalised ratio (INR) * Measurement Tool: Laboratory coagulation analysis * Unit of Measure: Ratio (unitless)
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Metabolic and Biochemistry Panel (E/LFT Panel - MB2)
* Name of Measurement: Estimated glomerular filtration rate (eGFR) * Measurement Tool: Laboratory calculation based on serum creatinine * Unit of Measure: mL/min/1.73 m²
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Liver Function Tests
11af. Total Bilirubin * Name of Measurement: Total bilirubin * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: µmol/L 11ag. Direct Bilirubin * Name of Measurement: Direct bilirubin * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: µmol/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Glycaemic Markers
11ao. HbA1c * Name of Measurement: Glycated hemoglobin (HbA1c) * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: %
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
8f. Electrical Activity of the Heart (Electrocardiography)
8f -1. Heart Rhythm * Name of Measurement: Cardiac rhythm * Measurement Tool: 12 lead electrocardiogram (ECG) * Unit of Measure: Rhythm classification (e.g. normal sinus rhythm, arrhythmia present/absent)
Time frame: 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.
8f. Electrical Activity of the Heart (Electrocardiography)
8f- 2. Heart Rate on ECG * Name of Measurement: Heart rate derived from ECG * Measurement Tool: 12 lead electrocardiogram (ECG) * Unit of Measure: Beats per minute (bpm)
Time frame: 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.
8f. Electrical Activity of the Heart (Electrocardiography)
8f- 6. ST Segment Abnormalities * Name of Measurement: ST segment deviation * Measurement Tool: 12 lead electrocardiogram (ECG) * Unit of Measure: Presence or absence of abnormality
Time frame: 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.
Infectious Disease Serology
11ar. Hepatitis C Antibody * Name of Measurement: Hepatitis C antibody * Measurement Tool: Laboratory serological analysis * Unit of Measure: Qualitative (positive/negative)
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Infectious Disease Serology
11as. Human Immunodeficiency Virus * Name of Measurement: HIV I/II serology * Measurement Tool: Laboratory serological analysis * Unit of Measure: Qualitative (positive/negative)
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Infectious Disease Serology
11at. Human T Lymphotropic Virus * Name of Measurement: HTLV I/II serology * Measurement Tool: Laboratory serological analysis * Unit of Measure: Qualitative (positive/negative)
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
Infectious Disease Serology
11au. Syphilis Serology * Name of Measurement: Syphilis serology * Measurement Tool: Laboratory serological analysis * Unit of Measure: Qualitative (positive/negative)
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
9. Pulmonary Function (Spirometry)
9b. Forced Vital Capacity * Name of Measurement: Forced vital capacity (FVC) * Measurement Tool: Spirometry * Unit of Measure: Litres (L)
Time frame: Outcome measured at screening, Priming Rehabilitation (PR) week 0 (for those who have had metal work removal surgery prior), PR week 13, Regenerative Rehab (RR) week 0, RR week 33 (33 weeks post commencement of regenerative rehab) intervention
Bone Mineral Density (DEXA)
10c. Z score * Name of Measurement: Bone mineral density Z score * Measurement Tool: Dual energy X ray absorptiometry (DEXA) * Unit of Measure: Z score (unitless)
Time frame: Outcome measured at screening, then Priming Rehabilitation (PR) week 13, Regenerative Rehabilitation (RR) week 33 post-commencement of Regenerative Rehab intervention
Full Blood Count (FBC)
11f. Platelet Count * Name of Measurement: Platelet count * Measurement Tool: Laboratory full blood count analysis * Unit of Measure: ×10⁹/L
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
8f. Electrical Activity of the Heart (Electrocardiography)
8f -4. QRS Duration * Name of Measurement: QRS complex duration * Measurement Tool: 12 lead electrocardiogram (ECG) * Unit of Measure: Milliseconds (ms)
Time frame: 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.
8f. Electrical Activity of the Heart (Electrocardiography)
8f-5. QT Interval (Corrected) * Name of Measurement: Corrected QT interval (QTc) * Measurement Tool: 12 lead electrocardiogram (ECG) * Unit of Measure: Milliseconds (ms)
Time frame: 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.
Coagulation Studies
11r. Activated Partial Thromboplastin Time * Name of Measurement: Activated partial thromboplastin time (aPTT) * Measurement Tool: Laboratory coagulation analysis * Unit of Measure: Seconds (s)
Time frame: Outcome measured at screening, then Priming Rehabilitaton (PR) week 13, Transplant Surgery (TS) week 4), Regenerative Rehab (RR) week 0, RR week 20, RR week 33, i.e. 33 weeks post commencement of regenerative rehab intervention.
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