Table 3.
Clinical trials reported with growth factors in the context of IVDD based on data from May 2023 (www.clinicaltrials.com).
| Status | Type | Trial ID | Phase | Result |
|---|---|---|---|---|
| Completed 2014 | Evaluate the safety, tolerability, and preliminary effectiveness of single administration intradiscal rhGDF-5 for the therapy of early-stage lumbar IVDD (1.0 and 2.0 mg) Open label Australia | NCT01158924 | 1/2 | Unclear if neurological, ODI and VAS outcome was an improvement, increased score for functional health and wellbeing Therapy emergent adverse effects in 14% (1.0 mg) and 4% (2.0 mg). |
| Completed 2013 | Intradiscal rhGDF-5 (0.25/1.0 mg) Open label United States | NCT00813813 | 1/2 | Unclear if neurological, ODI and VAS outcome was an improvement, increased score for functional health and wellbeing. Therapy emergent adverse effects in 29% (0.25 mg) and 4% (1.0 mg). |
| Completed 2014 | Evaluate the safety, tolerability, and preliminary effectiveness of single administration intradiscal rhGDF-5 for the therapy of early-stage lumbar IVDD. (placebo/1.0 mg) Randomized, double blind study. Republic of Korea | NCT01182337 | 1/2 | No therapy emergent adverse effects. Unclear if neurological, ODI and VAS outcome was an improvement, score for functional health and wellbeing indicates placebo effect. |
| Completed 2014 | Multicenter, randomized, double-blind, placebo controlled, clinical trial to evaluate the Safety, Tolerability and Preliminary effectiveness of 2 doses of intradiscal rhGDF-5 (for the therapy of early-stage lumbar IVDD) (placebo/1.0 mg/2.0 mg) Randomized, double blind study. United States. | NCT01124006 | 2 | No therapy emergent adverse effects. Unclear if neurological, ODI and VAS outcome was an improvement, score for functional health and wellbeing indicates placebo effect. |
| Not yet recruiting | Intradiscal and intra-articular injection of autologous platelet-rich-plasma (PRP) in patients with lumbar IVDD and facet joint syndrome. Open label. | NCT04816747 | 3 | No results posted |
ODI, Oswestry disability index (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale; VAS, visual analog scale pain score.