Amniox Medical today released results from a clinical study of its Clarix cryopreserved amniotic membrane in lumbar microdiscectomy surgeries, touting freedom from re-herniation for 2-years.
Results from the trial were published in the May 2017 issue of Clinical Spine Surgery, the Atlanta-based company said.
In the 80-person study, researchers compared the use of the Clarix 100 tissue, placed in the annular defect during microdiscectomy, against the standard of care without adjunctive tissue placement.
Patients who received the Clarix 100 showed greater improvements in pain reduction and daily function at 6 weeks through 2 years, and none of the patients treated with it experienced re-herniations up to 2 years. A total of 7.5% of patients in the control group demonstrated re-herniation, with 2 of 3 requiring spinal fusion to manage persistent pain.
“The data drawn from this study exhibits a significant improvement in clinical outcomes for patients receiving placental tissue following lumbar microdiscectomy, as measured by ODI and SF-12 PCS for pain and function respectively. 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,” study lead Dr. D. Anderson of Philadelphia’s Rothman Institute said in a prepared statement.
A 3rd cohort of patients is currently being enrolled to receive the Clarix Cord 1K cryopreserved umbilical cord tissue, Amniox said.
“This study adds to increasing clinical evidence concerning amniotic and umbilical cord tissue for reducing pain and improving function following surgical procedures. This is another important example of the expanding role for amniotic and umbilical cord tissue as regenerative therapies to improve surgical outcomes,” CEO Tom Dugan said in a press release.
In April, Amniox Medical said it landed a Federal Supply Schedule contract for its Neox and Clarix regenerative product lines with the US Military Health System.