The results of a clinical study on the efficacy of Amniox’ Clarix 100 cryopreserved amniotic membrane in lumbar microdiscectomy surgery have demonstrated greater improvements in both pain reduction and function from six weeks post-surgery than a control group.
The research—which was published online in Clinical Spine Surgery—was led by Greg Anderson, of the Rothman Institute in Philadelphia, USA. The published results include 80 patients who were prospectively randomised. Forty patients received the Clarix 100, a CryoTek-cryopreserved placental tissue, placed in the annular defect upon removal of the disc fragment during microdiscectomy. Another 40 received standard care—the same surgery without adjunctive tissue placement.
Patients who received Clarix 100 demonstrated greater improvement in both pain reduction and in daily function as early as six weeks post-surgery, with consistent continued improvement throughout the study follow-up endpoint of two years.
None of the patients who received Clarix 100 experienced re-herniation during the two-year follow-up period, while 7.5% of the control group demonstrated re-herniation. Specifically, three control group patients experienced a re-herniation at the same level, with two of the three requiring spinal fusion to manage persistent pain.
A third cohort of 40 patients—not included in the published results—is currently being enrolled. Those patients are receiving Clarix Cord 1K, the first cryopreserved umbilical cord tissue available to the market. This umbilical cord product is intended to be more potent than the amniotic membrane product.
Anderson presented the interim findings of the umbilical cord cohort at the International Society for the Advancement of Spine Surgery conference (ISASS17; 12–14 April, Boca Raton, USA). Those early results indicate that patients are responding even more favourably to treatment with the proprietary umbilical cord technology.
“The data drawn from this study exhibits a significant improvement in clinical outcomes for patients receiving placental tissue following lumbar microdiscectomy, as measured by Oswestry Disability Index and Short Form-12 Physical Component Summary for pain and function respectively,” Anderson said. “Additionally, there was a lower rate of recurrent herniation with the use of a placental tissue graft compared to the outcomes associated with microdiscectomy procedures without these tissues. These results indicate the application of these tissue grafts significantly reduced pain, enhanced the healing response and improved post-surgical outcomes.”