Olfactory Cell Transplantation and Intensive Rehabilitation to Repair Chronic Spinal Cord Injury

NCT07596563 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: GUSIP03
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurological Conditions; Spinal Cord Injury; Rehabilitation Exercise

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (85)

• 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.

Study Arms (2)

Treatment group of cell and rehabilitation

ACTIVE COMPARATOR

20 participants will be recruited

Biological: Olfactory Ensheathing Cell, biological intervention

Control Rehabilitation only group

ACTIVE COMPARATOR

10 participants will be recruited

Other: rehabilitation

Interventions

Olfactory Ensheathing Cell, biological intervention BIOLOGICAL

Treatment group of cell transplantation and rehabilitation

Treatment group of cell and rehabilitation

rehabilitation OTHER

control rehabilitation only group

Control Rehabilitation only group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).
• 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;

Sponsors & Collaborators

• Dr Brent McMonagle: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Brent McMonagle, Dr

  Gold Coast University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Rayfield

CONTACT

+61(0) 7 5678 0917; scitrial@griffith.edu.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: May 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): August 1, 2031
• Last Updated: May 19, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE