SpinalCyte, LLC is headquartered in Texas, the regenerative medicine company focused on the use of its universal donor nucleus pulposus recycling products CybroCell TM, the company announced today, FDA has approved its investigational new drug (IND) in the US A program for human trials, which is considered to be the first time that fibroblasts have been approved for the treatment of chronic diseases other than skin diseases. The approval allowed SpinalCyte to begin recruiting and screening patients for the study. The test will be initiated after the first production run has passed quality and safety testing to meet FDA requirements. Pete O'Heeron, CEO of SpinalCyte, said: "Our fibroblast treatment product CybroCell TM has been approved by the IND for the treatment of intervertebral disc degeneration, validating our clinical science and is our biggest step towards commercialization. Our After a very positive result in Phase 1 / Phase 2 clinical trials, the FDA approval will allow us to continue testing CybroCell TM and will continue our mission to relieve back pain, which affects millions of Americans each year. CybroCell TM can be applied Diseases other than degeneration of the intervertebral disc and are expected to be used in other disease pathways, including cancer, diabetes, osteoarthritis, liver failure, and heart failure." Phase 1 / 2 trials were used to assess pain and structural improvement in patients with Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and MRI scans. The data showed that 54% of the patients in the treatment group achieved all 3 endpoints, compared with only 17% of the placebo group (p=0.0003). In the treatment group, the Oswestry Disability Index (ODI) scored more than 10% for more than 10%, the visual analog scale (VAS) improved to 100%, and the intervertebral disc height increased or decreased by more than 84%. SpinalCyte Chief Scientific Officer Dr. Thomas Ichim expressed: "CybroCell pain and MRI data show that treatment is superior to all other cells in the intervertebral disc degeneration of the IND approval allows us to continue our research and application CybroCell TM for the treatment of degenerative disc. become the root cause of chronic pain is a major medical breakthrough. we observed long-lasting structural and functional improvement in patients, is expected to show CybroCell TM by eliminating chronic pain to help fight the spread of opioids. " Fire Valve,Fire Gate Valve,Fire Fighting Gate Valve,Fire Gate Flanged Valve Huaian Wuzhou E-Commerce Co.,Ltd , https://www.wzfirefighting.com