Here are nine key developments in stem cell research for spine this year:
Rochester, Minn.-based Mayo Clinic released a case report in November detailing how 10 patients responded to a stem cell therapy for spinal cord injuries. One paralyzed patient experienced "remarkable" results in his ability to walk when injected with the drug after having a spinal decompression and surgery to fuse his cervical vertebrae.
Oakland-based California Institute for Regenerative Medicine, which awarded grants for spinal cord injuries and nerve-regeneration research, is expected to run out of funds by the end of 2019. The Institute was awarded a $3 billion bond in 2004 to fund stem cell-related projects. State voters are pondering whether to support a ballot initiative 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. The U.S. alleges the defendants — Chief Scientific Officer Kristin Comella, PhD, for US Stem Cell Clinic and US Stem Cell — advertised "stromal vascular fraction" products as stem-cell based treatments for conditions such as spinal cord injuries, stroke and brain injury. The court entered a permanent injunction banning the defendants from selling 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. They 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 regrowth, 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 Translational Medicine in August found that an injection 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 myelomeningocele and injected human amniotic fluid stem cells in each of their amniotic cavities. The study showed that in-utero therapy with hAFSCs may be effective in treating fetal myelomeningocele.
DiscGenics is enrolling 24 patients in a clinical trial exploring the efficacy of IDCT — an allogenic, injectable disc cell therapy — in treating mild to moderate degenerative disc disease. An independent data safety monitoring company completed a final safety review after 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 biomaterial that could provide targeted treatment to injured spinal cords and tissue to prevent additional damage. They created a biomaterial to protect nervous system cells and promote regeneration. Researchers are eyeing preclinical testing to explore how their polymerized fibers would work in a living system.
NC Biomatrix BV is producing a biomaterial that will assist the treatment of intervertebral 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 clinical 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 recovered 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.
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