Creative Medical Technology Holdings (CELZ) announced positive mid-term results from its StemSpine pilot study using AlloStem cells to treat chronic lower back pain. The study showed significant reductions in opioid use, pain levels, and functional disability three years post-procedure, with a strong safety profile. StemSpine is a patented, non-surgical, ultrasound-guided procedure utilizing AlloStem, an “off-the-shelf” allogeneic cell therapy.
These findings are particularly important because they address a critical unmet need in chronic lower back pain management. The high success rate in reducing opioid dependency offers a potential solution to the ongoing opioid crisis, while improvements in pain and mobility can significantly enhance patients’ quality of life. This non-surgical approach also presents a less invasive alternative to traditional interventions, potentially reducing recovery times and associated risks.
The pilot study demonstrated that over 90% of patients ceased opioid use for pain management three years after the StemSpine procedure. Pain scores decreased by 80%, and Oswestry Disability Index scores, a measure of functional disability, improved by over 60%. Furthermore, only one patient required reintervention after three years, and no serious adverse events were observed. This data complements the company’s ongoing FDA-cleared Phase 1/2 ADAPT clinical trial for chronic lower back pain using CELZ-201-DDT, although the pilot study is independent of this trial.
These positive results position StemSpine as a potential game-changer in the treatment of chronic lower back pain. The strong efficacy and safety data could lead to wider adoption of the procedure, offering a viable non-opioid treatment option for millions of patients. This advancement could significantly impact the healthcare landscape by reducing opioid reliance and improving the lives of individuals suffering from this debilitating condition. Further research and larger-scale clinical trials will be crucial to confirm these findings and establish StemSpine’s long-term efficacy and safety.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
