If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Phase 2 study
Not yet recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Spine & Scoliosis Service | Kogarah | NSW | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria
1. Persistent low back pain, with at least 3 months of non-surgical therapy, at one symptomatic disc or two symptomatic lumbar disc levels (from L2 to S1).
2. MRI scans show Pfirrmann disc degeneration grade 2 to 4 or High Intensity Zone (HIZ) signal change with or without Modic endplate changes.
3. Symptoms are a fair bit or a lot bothersome, which require medication or other types of treatments or very disrupting (in response to question\*).
4. Preoperative Oswestry Disability Index (ODI) score greater than or equal to 30%
5. Visual Analog Score for back pain ≥40 mm.
6. Any gender, 18 years of age or older
7. Clinician diagnosed discogenic pain
8. A signed HREC-approved Informed Consent Form
9. Able to meet the protocol follow-up schedule and activities
10. Females of childbearing potential must have a negative urine/serum pregnancy test at screening (Baseline Visit) and on the day of administration prior to injection \*Question defined in full protocol
Exclusion Criteria
1. People unable to have an MRI
2. Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
3. Active radicular pain due to anatomical compression such as stenosis or disc herniation
4. Symptomatic facet joints and/or severe facet degeneration at the index level or adjacent segments
5. Symptomatic Sacro-iliac joint
6. MRI findings demonstrate any of the following: Suspected disc appears normal or \>50% decrease in disc height or Presence of symptomatic osteophytes
7. Any prior lumbar spinal surgeries at suspected symptomatic level; prior surgery at the adjacent levels is acceptable including fusion or arthroplasty, provided the said adjacent level is not independently symptomatic.
8. Presence of spondylolisthesis (anterolisthesis, retrolisthesis is acceptable)
9. Symptomatic disc degeneration at more than 2 lumbar levels (multi-level disc degeneration based on MRI findings is acceptable with up to two symptomatic level. Only the symptomatic levels will be treated)
10. Evidence of active infection
11. Immunosuppressive therapy within 3 months prior to investigational product administration
12. Either continuous or cumulative use of more than 2 months use in the past 6 months of an oral or systemic steroid. Inhaled steroids are acceptable
13. Tumor in the spine
14. People with any current and previous cancer. An exemption to this is previous BCCs which have been successfully removed.
15. Non-contained herniated nucleus pulposus
16. Any prior intradiscal therapies (chemonucleolysis, IDET, intradiscal steroid injection) at the same level being treated, other than rhGDF-6.
17. Any non-intradiscal steroid injection less than 2 months prior to administration. Does not include isolated joint injections outside the lumbar region.
18. Nerve block injection less than 2 months prior to injection of study medication.
19. Known autoimmune disease
20. Type 1 Insulin-dependent diabetes mellitus (Type II, non-insulin dependent diabetes mellitus is allowed)
21. Pregnant or lactating, or wishes to become pregnant within the first 12 months of the study
22. Involved in pending litigation of the spine (including workers compensation cases)
23. Demonstrates signs of non-organic pain (e.g., Waddell's Signs)
24. Based on clinical history, physical examination and participant presentation, participant has, or is suspected to have, a history of alcohol and/or drug abuse that would preclude participants from providing adequate consent and/or complying with study requirements
25. Prisoner
26. Morbid Obesity, defined as Body Mass Index (BMI) ≥40
27. Life expectancy less than 2 years
28. Any significant psychological disturbance past or present, that could impair the consent process or ability to complete participant self-report questionnaires
29. Any reason not cited above that, in the opinion of the Principal Investigator, would pose a risk to either the participant or to the integrity of the clinical trial
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 25 June 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.