Results from a study that received the 2016 Best Basic Science Abstract Award at the Spine Intervention Society Annual Meeting indicated allogenic mesenchymal precursor cells injected into the discs of patients with chronic low back pain were well tolerated and the treatment showed no clinical evidence of an immune response.
“The long-term results from this study indicate that a single injection of Mesoblast’s allogenic mesenchymal precursor cells (MPCs) into the disc of patients with moderate to severe [chronic low back pain] CLBP due to degenerative disc disease was well tolerated and provided substantial improvement in pain and function over 24 months compared with control therapies,” Michael J. DePalma, MD, president and medical director of Virginia iSpine Physicians, said in a press release from Mesoblast Limited.
Michael J. DePalma
DePalma and colleagues performed a randomized controlled trial of 100 patients with CLBP and placed the patients to one of the following groups: saline placebo control; hyaluronic acid (HA)-vehicle control; 6 million MPCs with HA; and 18 million MPCs with HA. Safety was determined by factors such as adverse events, treatment failure and immunological testing. Effectiveness was assessed by factors such as the VAS score, the Oswestry Disability Index and radiographic changes.
According to the release, results showed the 6 million MPCs group had the greatest proportion of patients who met the primary endpoint for overall treatment success through 2 years. Investigators noted at 12 months and 24 months, a larger portion of patients treated with 6 million MPCs achieved pain responder criteria compared with the saline group. The pain responder criteria were met by 36% of patients treated with 18 million MPCs and by 23% of patients treated with HA.
Investigators also found that at both 12 months and 24 months, a greater proportion of patients who received 6 million MPCs achieved functional responder criteria compared with patients treated with saline. The release noted 53.9% of patients treated with 18 million MPCs and 29.4% of patients treated with HA met functional responder criteria.
At both 12 months and 24 months, the overall treatment success was achieved by 38.5% of patients treated with 6 million MPCs, 34.6% of patients treated with 18 million MPCs, 17.7% of patients treated with HA and by 12.5% of patients treated with saline.
DePalma M, et al. Randomized, controlled trial evaluating safety and effectiveness of immunoselected, allogenic mesenchymal precursor cells for low back pain. Presented at: Spine Intervention Society Annual Meeting; July 27-30, 2016; New Orleans.
Disclosures: DePalma reports he is a coinvestigator for Mesoblast, Spinal Restoration, ATRM/DePuy, Stryker Biotech, St. Jude Medical, NIH-funded LSS/ESI trial, Si Bone and Vertiflex; and is a consultant for Vertiflex, Zyga and Anges.