Tag: Clinical Trial
Recent surgical trials have bestowed new life on quadriplegics who can now return to activities they never thought they’d be able to do again, thanks to an innovative surgery that relocates nerves.
A dirt bike accident in 2015 left Australian Paul Robinson, now in his 30s, paralyzed from the chest down. Robinson landed on his head and broke one of the vertebrae in his neck, leaving him confined to a wheelchair and rarely able to leave his home. He was one of 16 people participating in a medical trial at Austin Health in Melbourne that used nerve transfers to re-enervate paralyzed muscles in quadriplegic patients.
Marios Papadopoulos and Samira Saadoun talk to Spinal News International about the ISCoPE trial, which aimed to develop techniques to continuously monitor the pressure of the spinal cord at the injury site in the intensive care unit (ICU). They conclude that monitoring from the injury site provides clinically important information, and note that they are now in the process of setting up a randomised controlled trial to test whether, compared with bony decompression, expansion duroplasty improves functional outcome after severe spinal cord injury.
Japanese Researchers Will Use Stem Cells to Treat Spinal Cord Injuries in Groundbreaking Clinical...
There could a new form of treatment in Japan for spinal cord injuries if a newly-approved clinical trial hits the mark.
On Monday, a special committee of the Ministry of Health, Labor and Welfare in Japan approved a clinical research program at Tokyo’s Keio University to use induced pluripotent stem (iPS) cells to treat spinal cord injuries. According to the Nikkei Asian Review, this is a groundbreaking first-of-its-kind study. The clinical trial is expected to begin this summer.
First-in-human clinical study found improved motor and sensory function in three of four participants
Writing in the June 1 issue of Cell Stem Cell, researchers at University of California San Diego School of Medicine report that a first-in-human phase I clinical trial in which neural stem cells were transplanted into participants with chronic spinal cord injuries produced measurable improvement in three of four subjects, with no serious adverse effects.
People with spinal cord injuries rely on catheters to empty their bladder. When a well-respected publication concluded that catheters could be reused without an increased risk of infection, it didn’t sit right with a Vancouver clinician and researcher. He had spoken to wheelchair athletes about this very issue while working at the Summer Paralympics in London.
“Wheelchair athletes from wealthier countries would only use each catheter once while athletes from developing countries would clean and reuse their catheters again and again,” said Dr. Andrei Krassioukov, a professor of medicine at UBC and chair in rehabilitation research with ICORD. “The athletes who used catheters only once experienced three-to-four times fewer urinary tract infections than athletes who reused catheters.”
Injection after an injury reduces inflammation and scarring
After a spinal cord injury, a significant amount of secondary nerve damage is caused by inflammation and internal scarring that inhibits the ability of the nervous system to repair itself.
A biodegradable nanoparticle injected after a spinal cord trauma prevented the inflammation and internal scarring that inhibits the repair process, reports a new Northwestern Medicine study.
Lengthy study finds that implanted neural stem cells grow slow and steady, and success needs to be measured accordingly
More than one-and-a-half years after implantation, researchers at University of California San Diego School of Medicine and the San Diego Veterans Administration Medical Center report that human neural stem cells (NSCs) grafted into spinal cord injuries in laboratory rats displayed continued growth and maturity, with functional recovery beginning one year after grafting.
A cell therapy intended to boost myelin regeneration — Q-Cells by Q Therapeutics — has received a green light from the U.S. Food and Drug Administration to proceed with a clinical trial in patients with transverse myelitis (TM), a disease that like multiple sclerosis is characterized by myelin damage.
FDA approval of the company’s Investigational New Drug (IND) application allows researchers to start a Phase 1/2 clinical trial in which nine patients will receive increasing doses of the treatment.
Ability to enroll patients with second most common cervical spinal cord injury broadens eligible population for SCiStar study and future trials
FREMONT, Calif., July 10, 2017 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s amendment to the clinical research protocol for its ongoing AST-OPC1 SCiStar Phase 1/2a clinical trial in motor complete cervical spinal cord injury (SCI). The amendment expands the eligibility criteria to include patients with a C-4 spinal cord injury and extends the dosing window from 14 to 30 days to 21 to 42 days post-injury.
Third patient recovers two motor levels; three of six (50%) patients in AIS-A 10 million cell cohort have now recovered two motor levels on at least one side
FREMONT, Calif., June 13, 2017 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced that new 9-month follow-up data from the AIS-A 10 million cell cohort in the company’s ongoing SCiStar Phase 1/2a clinical trial shows three of six (50%) patients have now recovered two levels of motor function and previously-announced improvements in arm, hand and finger function at 3-months and 6-months following administration of AST-OPC1 have been confirmed and further increased at 9-months.