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Intradiscal rhGDF-6 for the Treatment of Lumbar Disc Degeneration

NCT07668466 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-25

No results posted yet for this study

Summary

The goal of this clinical trial is to find out if a new medicine can help people who have long-lasting back pain caused by damaged spinal discs. The study will also check if the medicine is safe to use.

The main questions this study aims to answer are:

Is the medicine safe, and what amount works best? Can it reduce long-term back pain?

Researchers will test a medicine called CBT005, which contains a healing protein, by injecting it into the spinal discs. They will watch closely to see how people respond to the treatment.

Participants will:

Receive one study injection into the spinal disc Visit the clinic in person during the first 12 months for checkups Receive phone calls at 24 and 36 months to see how they are doing Still be able to get other pain treatments in the future, including surgery, if needed

Conditions

Interventions

BIOLOGICAL

High Dose

High Dose: 4 mg dose of Growth differentiation factor 6

BIOLOGICAL

Low Dose

Low dose: 2mg dose of Growth differentiation factor 6

Sponsors & Collaborators

  • Cartago Biotech Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-04
Primary Completion
2028-08-31
Completion
2030-12-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07668466 on ClinicalTrials.gov