Becker's Spine Review

13 SPINE SURGEONS 9 big developments in stem cell research for spine in 2019 By Alan Condon Here are nine key developments in stem cell research for spine this year: Rochester, Minn.-based Mayo Clinic re- leased a case report in November detailing how 10 patients responded to a stem cell therapy for spinal cord injuries. One para- lyzed patient experienced "remarkable" re- sults in his ability to walk when injected with the drug aer having a spinal decompression and surgery to fuse his cervical vertebrae. Oakland-based California Institute for Re- generative Medicine, which awarded grants for spinal cord injuries and nerve-regen- eration research, is expected to run out of funds by the end of 2019. e Institute was awarded a $3 billion bond in 2004 to fund stem cell-related projects. State voters are pondering whether to support a ballot ini- tiative that will grant $5.5 billion to continue funding efforts. In June, a federal court ordered that Sunrise, Fla.-based regenerative medicine companies US Stem Cell Clinic and US Stem Cell stop providing stem cell treatments to patients. e U.S. alleges the defendants — Chief Sci- entific Officer Kristin Comella, PhD, for US Stem Cell Clinic and US Stem Cell — adver- tised "stromal vascular fraction" products as stem-cell based treatments for conditions such as spinal cord injuries, stroke and brain injury. e court entered a permanent in- junction banning the defendants from sell- ing or providing the products without FDA approval. Researchers at UC San Diego School of Medicine and Institute of Engineering are using 3D technology to print spinal cords. ey are implanting the scaffolding, which is loaded with neural stem cells, into rats with severe spinal cord injuries. Researchers found that the scaffolds supported tissue re- growth, stem cell survival and expansion of neural stem cell axons out of the scaffolding and in the host spinal cord. A study published in Stem Cells Transla- tional Medicine in August found that an in- jection of human amniotic fluid stem cells can be used to protect the spinal cord of a fetus from myelomeningocele. Researchers induced 116 pregnant rats with fetal myelo- meningocele and injected human amniotic fluid stem cells in each of their amniotic cav- ities. e study showed that in-utero therapy with hAFSCs may be effective in treating fe- tal myelomeningocele. DiscGenics is enrolling 24 patients in a clini- cal trial exploring the efficacy of IDCT — an allogenic, injectable disc cell therapy — in treating mild to moderate degenerative disc disease. An independent data safety moni- toring company completed a final safety re- view aer the first six subjects in the high- dose study group were treated and gave DiscGenics the all-clear in October. Researchers at Troy, N.Y.-based Rensselaer Polytechnic Institute are designing a bioma- terial that could provide targeted treatment to injured spinal cords and tissue to prevent additional damage. ey created a bioma- terial to protect nervous system cells and promote regeneration. Researchers are eye- ing preclinical testing to explore how their polymerized fibers would work in a living system. NC Biomatrix BV is producing a biomate- rial that will assist the treatment of inter- vertebral disc degeneration in a minimally invasive way. It is a cell-driven matrix gel that can be injected into the spinal disc and repair disc volume and height, easing pain in patients suffering from degenerative disc disease. Asterias Biotherapeutics conducted a clini- cal trial to study the effectiveness of OPC1 cells in 25 patients with severe spinal cord injuries. Asterias found that 95 percent of patients treated with 10M or 20M cells re- covered at least one motor level on at least one side, and 32 percent recovered at least two levels of motor function on at least one side. n 5 spine, neurosurgery devices recalled in 2019 By Alan Condon Here are five spine and neurosurgical devices recalled by the FDA in 2019. Johnson & Johnson's DePuy Synthes voluntarily recalled its USS II Polyaxial 3D heads, according to an urgent field safety notice issued out of Switzerland in November. The devices are part of the USS II Polyaxial System, a posterior pedicle screw fixation system designed to provide spine stabilization in skeletally mature patients, and not available in the U.S. Zimmer Biomet recalled the ROSA Brain 3.0 Robotic Sur- gery System in November due to a software issue that can drive the robotic arm to an incorrect position. Zimmer Biomet received five complaints related to the issue, in- cluding one patient injury. No deaths related to this issue were reported. Alpha Omega Engineering's Neuro Omega system, used to assist neurosurgeons in identifying brain structures during neurosurgery, was recalled in May due to a de- sign flaw that may fuse two separate electrode stimulation channels into one. The flaw, causing unplanned electrical stimulation, could cause significant harm to a patient's brain tissue. No patient injuries or deaths were reported. In April, Brainlab recalled its Spine & Trauma 3D Naviga- tion Software due to the potential for incorrect information to display during surgery, which may prevent the surgeon from accurately navigating tools inside the patient. The flaw could result in a second surgical procedure, life-threaten- ing patient injuries or death. Medtronic recalled the Synergy Cranial Software and StealthStation S7 Cranial Software used with the Stealth- Station Surgical Navigation System in January. The recall was due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm. The software defect could affect the neurosurgeon and have them insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels. n

• Cover