FDA Clears SpinalCyte IND Application for Universal Donor Cell Therapy to Treat Lower Back Pain
SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using its universal donor product, CybroCell™, today announced the FDA has cleared its Investigational New Drug (IND) protocol for human trials in the U.S., considered to be the first IND approval for a fibroblast cell therapy in a chronic condition outside of dermatological uses. The clearance allows SpinalCyte to begin recruiting and screening patients for the study. The trial is to be initiated after the first production run is tested for quality and safety to meet the FDA stated criteria.
“The clearance of the IND for our fibroblast-based therapy, CybroCell™, in the treatment of degenerative disc disease validates our clinical science and is our biggest step toward commercialization,” said SpinalCyte Chief Executive Officer, Pete O’Heeron. “After the extremely positive results from our Phase 1/Phase 2 clinical trial, this clearance by the FDA will allow us to continue testing CybroCell™ and will further our mission of bringing back pain relief to the millions of Americans who suffer from it every year. The applications of CybroCell™ go beyond degenerative disc disease and hold promise in other disease pathways including cancer, diabetes, osteoarthritis, liver failure and heart failure.”
The Phase 1/Phase 2 trial assessed pain and structural improvements in patients using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and MRI scans. The data showed that 54% of the treatment arm patients met all three endpoints as compared to only 17% with the placebo (p=0.0003). More than 90% of patients in the treatment group had an over a 10-point reduction in Oswestry Disability Index (ODI), 100% had improvement in Visual Analogue Scale (VAS) and over 84% had an increase or no change in disc height.
“CybroCell’s pain and MRI data show clear superiority to all other cell therapy treatments for degenerative disc disease,” said SpinalCyte Chief Scientific Officer, Thomas Ichim, Ph.D. “This IND clearance allows us to continue our research and application of CybroCell™. This treatment which targets the source of chronic pain in degenerative disc disease is a medical breakthrough. The persistent structural and functional improvements we have observed in patients demonstrate that CybroCell™ has the potential to help combat the opioid epidemic by eliminating chronic pain.”
About Degenerative Disc Disease
Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.
CybroCell™ is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated after 12 months, patients who were injected with CybroCell™ had sustained improvement in pain relief and increased back mobility.
Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 35 U.S. and international issued patents and has filed for an additional 41 patents pending. SpinalCyte holds 116 U.S. and International Patents pending and issued across a variety of disease pathways, including disc degeneration, cancer, diabetes, liver failure and heart failure. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Blue Danube Systems Coherent Massive MIMO Delivers Industry’s Highest Capacity Gains in Multiple Commercial Networks22.2.2019 02:00:00 | Tiedote
Blue Danube Systems, a provider of intelligent wireless access solutions that help mobile operators address the challenge of explosive data growth, is today announcing significant results from multiple new FDD deployments in commercial networks with live traffic. These multi-unit installations show more than 2.5 times higher cellular capacity and significantly increased user throughputs for both legacy LTE terminals as well as new generation smartphones. Blue Danube’s BeamCraft™ 500 antennas were deployed in 4G LTE networks in dense urban megacities and other areas with high traffic load nearing full bandwidth utilization. The systems exploited intelligent analytics-based multi-site optimization, and the performance was measured directly from the operators’ network performance management systems. The results exhibit increasing gains with the number of units deployed and highlight the benefits of multi-site optimization and coordination. Consistent performance improvements were observed
Blue Danube Systems Expands Operations in India and Welcomes Sundeep Raina to the Global Sales Management Team22.2.2019 01:00:00 | Tiedote
Blue Danube Systems, a provider of intelligent wireless access solutions that help mobile operators address the challenge of explosive data growth, is announcing that Sundeep Raina has joined the company as the Country Sales Director of India. Mr. Raina joins Blue Danube with over 19 years of industry experience in telecommunications equipment sales and key account management most recently with ZTE Corporation and previously at Ericsson India. Mr. Raina will be responsible for developing new business relationships, managing current engagements and sales expansion in India. He will be based in Mumbai close to Blue Danube’s customers and partners. “We are excited to have Sundeep on board and look forward to Blue Danube’s continued progress in India,” said John Shelnutt, Blue Danube’s Vice President of Sales. “With the recent positive developments and increasing interest towards our solutions we decided to increase our presence in India to better serve our key customers. Sundeep has demon
Blue Danube Systems Enhances BeamPlanner™ Software Including Artificial Intelligence and Machine Learning Capabilities21.2.2019 23:00:00 | Tiedote
Blue Danube Systems, a provider of intelligent wireless access solutions that help mobile operators address the challenge of explosive data growth, is today announcing new capabilities into its BeamPlanner™ cloud software suite. BeamPlanner is the world’s first network planning and optimization tool for beamforming antenna systems. With the new and enhanced artificial intelligence (AI) and machine learning (ML) functionalities, BeamPlanner becomes the automated platform for network-wide operation of Blue Danube’s Coherent Massive MIMO systems. BeamPlanner utilizes an intelligent analytics-based, data-driven multi-site optimization engine that now has been enhanced with 3D ray tracing capabilities for improved prediction results accuracy. The simulation platform provides actionable beamforming recommendations and expected capacity results matching the real-world performance results validated through drive tests, network statistics data and standard key performance indicators (KPIs). In
Recipients of HCL GRANT 2019 Felicitated by Amitabh Kant & Sourav Ganguly21.2.2019 22:06:00 | Tiedote
Mr. Amitabh Kant, CEO, Niti Aayog and Mr. Sourav Ganguly, Former captain of the Indian National Cricket Team felicitated the winners of HCL Grant 2019 at a ceremony held today at HCL Technologies Campus, Noida, in the presence of Mr. Shiv Nadar, Founder & Chairman, HCL, Ms. Roshni Nadar Malhotra, Vice Chairperson, HCL Technologies and Chairperson, CSR Committee, HCL Technologies, along with senior dignitaries, bureaucrats, NGO-partners and the HCL leadership. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005822/en/ L to R - Ms. Roshni Nadar Malhotra, Vice Chairperson, HCL Technologies and Chairperson, CSR Committee, HCL Technologies; Mr. Sourav Ganguly, Former Captain of Indian National Cricket Team; Mr. Amitabh Kant, CEO, NITI Aayog and Ms. Robin Abrams, former president of Palm Computing and longest-serving Board member of HCL Technologies along with the HCL Grant 2019 recipients - Environment - Wildlife Trust of In
International Indigenous Languages Conference Set for June in British Columbia21.2.2019 20:48:00 | Tiedote
In celebration of the United Nations 2019 International Year of Indigenous Languages, the First Peoples’ Cultural Foundation (FPCF) and the First Peoples’ Cultural Council (FPCC), in partnership with the Canadian Commission for UNESCO, will host a major international conference on Indigenous language revitalization in British Columbia this summer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005758/en/ WHAT: The HELISET TŦE SḰÁL – ‘Let the Languages Live’ – 2019 International Conference on Indigenous Languages will bring together Indigenous leaders and language experts, speakers, learners and advocates from around the globe to celebrate, honour and share expertise in Indigenous language reclamation, revitalization and maintenance and to learn about successful language projects in B.C. The goal of the conference is to provide participants with practical skills and knowledge to support the Indigenous language revitaliz
Axilum Robotics Announces U.S. FDA 510(k) Clearance for TMS-Cobot21.2.2019 20:00:00 | Tiedote
Axilum Robotics, specializing in the development of medical robots, announces that, 2 weeks after the CE mark, the Company has received 510(k) clearance from the U.S. Food and Drug Administration to market the TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the treatment coil of the MagVenture TMS Therapy system. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005667/en/ Axilum Robotics TMS-Cobot (Photo: Business Wire) After having successfully developed and launched outside of the United States (OUS) the TMS-Robot, the first robot designed to assist health care professionals in delivering Transcranial Magnetic Stimulation (TMS), based on an invention of ICube laboratory in Strasbourg, Axilum Robotics has reinforced its expertise in medical robotics with the development of a new platform based on collaborative robot technology. TMS-Cobot, the first medical device built on this platform, allows
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme