Intradiscal rhGDF-6 for the Treatment of Lumbar Disc Degeneration

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

Timeline

Start

2026-07-04

Primary completion

2028-08-31

Completion

2030-12-01

Publications

• Background Wei A, Williams LA, Bhargav D, Shen B, Kishen T, Duffy N, Diwan AD. BMP13 prevents the effects of annular injury in an ovine model. Int J Biol Sci. 2009 Jun 3;5(5):388-96. doi: 10.7150/ijbs.5.388.
• Background Miyazaki S, Diwan AD, Kato K, Cheng K, Bae WC, Sun Y, Yamada J, Muehleman C, Lenz ME, Inoue N, Sah RL, Kawakami M, Masuda K. ISSLS PRIZE IN BASIC SCIENCE 2018: Growth differentiation factor-6 attenuated pro-inflammatory molecular changes in the rabbit anular-puncture model and degenerated disc-induced pain generation in the rat xenograft radiculopathy model. Eur Spine J. 2018 Apr;27(4):739-751. doi: 10.1007/s00586-018-5488-1. Epub 2018 Feb 19.

Drugs

Indications