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临床试验/NCT07596563
NCT07596563尚未招募1 期

Safety, Feasibility, Efficacy of Olfactory Cell Transplantation Therapy Combined With Intensive Exercise Rehabilitation to Repair Chronic Traumatic Spinal Cord Injury.

Dr Brent McMonagle0 个研究点目标入组 30 人开始时间: 2026年5月1日最近更新:
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适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
30
主要终点
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.
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • •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:
  • •Have sustained an acquired spinal cord injury a minimum of 4 months prior to consent and have completed their primary rehabilitation;
  • •Have a stable neurological level and functional ability of more than two months in duration;
  • •Are over 18 years and able to give informed consent;
  • •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;
  • •Have a thoracic injury or lower cervical (C5-C8) injury;
  • •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;
  • •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;
  • •Are considered by their general practitioner or specialist medical consultant to be fit to receive the cell transplantation and undertake the exercise program (documented approval by general practitioner required).
  • •Exclusion Criteria
  • •Participants are excluded from the trial if any of the following criteria apply:
  • •Have a high cervical (C1-C4) injury (excluded due to respiratory risk);
  • •Have significant concomitant central nervous system, peripheral nervous system or musculoskeletal system injuries or disorders limiting their ability to exercise;
  • •Have had recent major trauma or surgery within the last 4 months;
  • •Have an existing stage 3 or 4 pressure ulcer according to the National Pressure Ulcer Advisory Panel classification;
  • •Have endocrinopathy or metabolic disorders of the bone that lead to increased risk of injury from the intense long-term exercise therapy, including but not limited to pathological fractures, Paget's disease, lytic or renal bone disease, and senile osteoporosis;
  • •Have a medical history of exposure to medication(s) known to adversely affect mineral or bone metabolism;
  • •Have significant impairment or disability, including physical, neurological or psychological impairments, in addition to the spinal cord injury;
  • •Have a history of long bone fracture incompletely healed;
  • •Have extensive fixed contractures in the upper or lower limbs;
  • •Have severe spasticity that interferes with ability to exercise;
  • •Have uncontrolled neuropathic pain;
  • •Have autonomic dysreflexia without a management plan;
  • •Have a known allergic sensitivity to antibiotics used in the nerve bridge production process;
  • •Do not have adequate transport options to attend the rehabilitation sessions or the assessments;
  • •Are unable to attend the pre-intervention assessments and the follow-up assessments;
  • •Have any contraindications to FES, MRI, X-ray and other study procedures, such as a cardiac pacemaker, epilepsy, lower limb fracture or pregnancy;
  • •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 trial investigator, would prevent adherence to the protocol;
  • •Have symptomatic, radiologically demonstrated, or provocatively demonstrated ischaemic heart disease;
  • •Have current thromboembolic disease;
  • •Are using illicit drugs;
  • •Are participating in other clinical trials (including medication, therapeutic interventions and alternative therapies).
  • •Are unable to tolerate expected exercise load.
  • •Are unable to comply with the assessment regime (such as having claustrophobia which prevents MRI procedures being conducted);
  • •Are unable to demonstrate that they have adequate social/family/carer support at home to enable their participation throughout the trial.
  • •Evidence of an active infection, confirmed by testing, of a type that would pose an unacceptable risk for the viability of the nasal biopsy, the cell production, or the nerve bridge production.

研究组 & 干预措施

Treatment group of cell and rehabilitation

Active Comparator

20 participants will be recruited

干预措施: Olfactory Ensheathing Cell, biological intervention (Biological)

Control Rehabilitation only group

Active Comparator

10 participants will be recruited

干预措施: rehabilitation (Other)

结局指标

主要结局

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.

时间窗: 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.

时间窗: 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.

时间窗: 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.

次要结局

  • 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.)
  • 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)
  • 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.)
  • 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.)
  • 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)
  • 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.)
  • 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))
  • 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)
  • 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)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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)
  • 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.)
  • 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.)
  • 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.))
  • 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).)
  • 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.)
  • 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)
  • 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.)
  • 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.)
  • 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.))
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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)
  • 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)

研究者

发起方
Dr Brent McMonagle
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Brent McMonagle

Coordinating Principal Investigator

Griffith University

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