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. Continue Reading »
Published: July 10, 2017 | Category:News | Spinal Cord Injury:C-4
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. Continue Reading »
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. Continue Reading »
Patients suffering from complete spinal cord injuries have little to no treatment options that provide meaningful improvement in patient outcomes.
Cambridge, Mass.-based InVivo Therapeutics is trying to change that. Co-founded in 2005 by MIT professor Robert Langer, and surgeon-scientists Joseph Vacanti, M.D., the company has developed a small, bioresorbable and biocompatible device called the Neuro-Spinal Scaffold, to help patients with complete thoracic spinal cord injuries regain some function. Continue Reading »
In a Stanford-led research report, three participants with movement impairment controlled an onscreen cursor simply by imagining their own hand movements.
A clinical research publication led by Stanford University investigators has demonstrated that a brain-to-computer hookup can enable people with paralysis to type via direct brain control at the highest speeds and accuracy levels reported to date. Continue Reading »
A UCLA professor is helping paralyzed individuals regain use of their limbs through electric stimulation of the spinal cord.
In 2015, Reggie Edgerton, the director of the Neuromuscular Research Laboratory at UCLA, developed a robotic exoskeleton that helped a paralyzed man walk. Though the man is still paralyzed and cannot control the exoskeleton’s movement, Edgerton’s lab plans to do more research to make that happen. Continue Reading »
Early clinical trial results announced offer new hope in regenerative medicine
A new therapy to treat spinal cord injuries in people who have lost all motor and sensory function below the injury site shows additional motor function improvement at 6-months and 9-months following treatment with 10 million AST-OPC1. The positive efficacy results from an ongoing research study were announced on Jan. 24 in a conference held by Asterias Biotherapeutics, Inc., the biotechnology company that manufactures AST-OPC1. Continue Reading »
Queensland researchers are launching a world-first clinical trial aimed at improving recovery from spinal cord injuries.
In the study, led by The University of Queensland and The Princess Alexandra (PA) Hospital, a new anti-inflammatory drug will be given to participants within hours of spinal trauma in an effort to minimize tissue damage.
Stem cell research is often controversial but it has also led to incredible medical progress in recent years.
Stem cell research is at defining moment. Although it can be controversial and does raise a lot of important ethical issues, this area of medical science has been characterised by a number of important advances, ever since the first embryonic stem cells were isolated from mice in the 1980s. In the near future, it could reshape the way we treat some of the world’s most debilitating diseases.
Stem cells have already been used as treatment for a number of years – think bone marrow transplant – and they have the potential to help with many other medical conditions. Continue Reading »