Neurological Conditions, Rehabilitation Exercise, Spinal Cord Injury
Conditions
Brief summary
This is a randomised, blinded and controlled Phase I trial to measure the safety, feasibility and efficacy of a combined cell transplantation and intensive rehabilitation intervention to treat spinal cord injury. The trial aims to examine whether transplantation of olfactory cell nerve bridges combined with intensive rehabilitation is safe and feasible for people living with chronic spinal cord injury in Australia, and whether the intervention improves structural integrity of the spinal cord, functional recovery, overall health, and social 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.
Interventions
BIOLOGICALOlfactory Ensheathing Cell, biological intervention
Treatment group of cell transplantation and rehabilitation
OTHERrehabilitation
control rehabilitation only group
Sponsors
Dr Brent McMonagle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion/
Exclusion criteria
for participants have been determined in consultation with medical and rehabilitation specialists including a clinician with lived experience of SCI. Inclusion Criteria Participants are eligible to be included in the trial only if all the following criteria apply: 1. Have sustained an acquired 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. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 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. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 4a. Changes in AIS grade | 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) | 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. | 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. | 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. | 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) | 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 | 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) |
| Bone Mineral Density (DEXA) | Outcome measured at screening, then Priming Rehabilitation (PR) week 13, Regenerative Rehabilitation (RR) week 33 post-commencement of Regenerative Rehab intervention | 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) |
| Full Blood Count (FBC) | 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. | 11e. White Blood Cell Count * Name of Measurement: White blood cell count * Measurement Tool: Laboratory full blood count analysis * Unit of Measure: ×10⁹/L |
| Motor Function | 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. | 12a. Manual Muscle Testing Score * Name of Measurement: Motor function score * Measurement Tool: Injury specific motor testing evaluation * Unit of Measure: Ordinal score |
| Muscle Strength (5 RM) | 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. | 13a. Upper Limb Strength * Name of Measurement: Five repetition maximum strength * Measurement Tool: 5 Repetition Maximum strength testing * Unit of Measure: Kilograms (kg) |
| Pain | 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. | 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 |
| Cardiovascular function | 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 | 15a. Arm Ergometry Exercise Duration * Name of Measurement: Exercise tolerance * Measurement Tool: 6 Minute Graded Arm Cycle Ergometry Test * Unit of Measure: Minutes |
| Bowel, bladder function and independence | 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. | 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) |
| Fatigue | 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. | 17a. Fatigue Severity * Name of Measurement: Fatigue severity * Measurement Tool: Fatigue Severity Scale * Unit of Measure: Total score |
| Depression, Anxiety and Stress | 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. | 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 |
| Quality of Life | 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 | 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 |
| Suicidal ideation and behaviour. | 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. | 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 |
| Muscle tone | 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. | 21a. Spasticity Severity * Name of Measurement: Muscle tone * Measurement Tool: Modified Ashworth Spasticity Scale * Unit of Measure: Ordinal score (0-4) |
| Lived experience | 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.) | 22a. Participant Experience Themes * Name of Measurement: Lived experience of intervention * Measurement Tool: Semi structured qualitative interviews * Unit of Measure: Qualitative thematic outcomes |
| 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. | 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. | 3 weeks after completion of Regenerative Rehab (RR) intervention (RR week 32) at RR week 35 (Final study/End of study week). | 24a. Assessment Completion Rate * Name of Measurement: Feasibility of intervention delivery * Measurement Tool: Study specific feasibility calculation * Unit of Measure: Percentage (%) |
| Changes in electrophysiological assessments - Motor Evoked Potentials (MEP) | 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 | 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 | 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) | 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 | 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 | 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) | 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 | 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 | 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. | 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 (%) |
| Quantitative MRI and DTI -Anatomical Repair | 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 | 34a. Spinal Cord Cross Sectional Area * Name of Measurement: Spinal cord cross sectional area * Measurement Tool: Quantitative MRI * Unit of Measure: mm² |
| Exploratory rs fMRI - Functional Connectivity | 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. | 35a. Functional Connectivity Strength * Name of Measurement: Resting state functional connectivity * Measurement Tool: Resting state functional MRI * Unit of Measure: Pearson correlation coefficient (r) |
| Exploratory Safety - rs fMRI Signal Stability) | 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. | 36a. Temporal Signal to Noise Ratio * Name of Measurement: MRI signal stability * Measurement Tool: Resting state functional MRI * Unit of Measure: TSNR (unitless) |
| Bladder Function | 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.) | 37a. Bladder Pressure * Name of Measurement: Bladder function * Measurement Tool: Urodynamic studies * Unit of Measure: cmH₂O |
| Changes in AIS grade, total sensory score, and total motor score | 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 | 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 | 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. | 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. | 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. | 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. | 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) | 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- 3. PR Interval * Name of Measurement: PR interval * Measurement Tool: 12 lead electrocardiogram (ECG) * Unit of Measure: Milliseconds (ms) |
| White Blood Cell Differential (Absolute Counts) | 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. | 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 |
| Reticulocytes and Red Cell Indices | 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. | 11l. Reticulocyte Count * Name of Measurement: Reticulocyte count * Measurement Tool: Laboratory hematology analysis * Unit of Measure: ×10⁹/L or % |
| Inflammation Markers | 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. | 11n. C Reactive Protein * Name of Measurement: C reactive protein * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: mg/L |
| Coagulation Studies | 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. | 11q. Prothrombin Time * Name of Measurement: Prothrombin time * Measurement Tool: Laboratory coagulation analysis * Unit of Measure: Seconds (s) |
| Metabolic and Biochemistry Panel (E/LFT Panel - MB2) | 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. | 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 |
| Liver Function Tests | 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. | 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 |
| Lipid Profile | 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. | 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 |
| Glycaemic Markers | 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. | 11an. Fasting Serum Glucose * Name of Measurement: Fasting serum glucose * Measurement Tool: Laboratory biochemical analysis * Unit of Measure: mmol/L |
| Cardiac Biomarker | 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. | 11ap. NT proBNP * Name of Measurement: N terminal pro brain natriuretic peptide * Measurement Tool: Laboratory immunoassay * Unit of Measure: pg/mL |
| Infectious Disease Serology | 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. | 11aq. Hepatitis B Surface Antigen * Name of Measurement: Hepatitis B surface antigen * Measurement Tool: Laboratory serological analysis * Unit of Measure: Qualitative (positive/negative) |
| Microbiological Testing | 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. | 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) |
| 9. Pulmonary Function (Spirometry) | 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 | 9c. FEV1/FVC Ratio * Name of Measurement: FEV1/FVC ratio * Measurement Tool: Spirometry * Unit of Measure: Ratio (unitless) |
| 10. Bone Mineral Density (DEXA) | Outcome measured at screening, then Priming Rehabilitation (PR) week 13, Regenerative Rehabilitation (RR) week 33 post-commencement of Regenerative Rehab intervention | 10a. Areal Bone Mineral Density * Name of Measurement: Bone mineral density * Measurement Tool: Dual energy X ray absorptiometry (DEXA) * Unit of Measure: g/cm² |
Contacts
CONTACTAndrew Rayfield
PRINCIPAL_INVESTIGATORBrent McMonagle, Dr
Gold Coast University Hospital
Outcome results
None listed