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Use of plastic scaffolds to treat human spinal cord injuries is moving close to reality.
InVivo Therapeutics (Cambridge, MA) has developed a treatment based on a biocompatible polymer scaffold to provide structural support to a damaged spinal cord in order to stop tissue from scarring following a serious spinal cord injury. Each plastic unit will be custom produced for a specific location using 3D printers.
The company is now building cGMP (current good manufacturing practices) facilities to commercialize its technology. Proprietary manufacturing processes at a new plant in Cambridge, MA will include 46 3D printing machines and batch processes to create the scaffolds, according to a document on the comany's Web site. In Vivo Therapeutics currently only operates one 3D printer, and is still in the process of evaluating how to manufacture the scaffolds, CEO Frank Reynolds told Plastics Today.
"Our technology is a true platform that can be leveraged to create many products, including treatments for peripheral nerve injury and other conditions. We're currently under review at FDA for our first spinal cord injury treatment, and we look forward to receiving approval to begin those human studies," said Reynolds.
The porous biopolymer scaffold is made of polylactic-co-glycolic acid (PLGA) and polylysine. PLGA is already approved by the FDA for applications such as surgical sutures, drug delivery, and tissue engineering. It degrades naturally inside the body without requiring removal.
In a news conference at the annual meeting of the American Chemical Society, MIT Professor Robert Langer, one of the developers of the technology, said: "You see dramatic differences in the abilities of test animals (rats and monkeys) to walk. We hope to begin clinical trials in the next year." The completion of the human clinical studies and FDA approval could take between three to five years.
The company expects that the product will be regulated under the Humanitarian Use Device/Humanitarian Device Exemption (HUD/HDE) pathway in an effort to accelerate commercialization.
There currently is no effective treatment for paralysis caused by spinal cord injuries. The market potential is estimated to be in excess of $10 billion.
Only a very small percentage of patients ever regain full functionality and the cost of care can be more than $1 million in the first year alone, depending on severity of injury. Invivo Therapeutics says that its unit is expected to cost $60,000, but it could exceed $100,000 per unit.
Technology will be rolled out in phases:
• First is the scaffolding device to treat acute spinal cord injuries.
• Next is a biocompatible hydrogel for local controlled release of methylprednisolone to treat acute spinal cord injuries and peripheral nerve injuries.
• Third is a biocompatible polymer scaffolding device seeded with autologous human neural stem cells to treat acute and chronic spinal cord injuries.
The proprietary technology was co-invented by Langer and Joseph P. Vacanti, MD, who is affiliated with Massachusetts General Hospital. The intellectual property rights are licensed exclsuviely from Children's Medical Center Corp. and MIT.
InVivo Therapeutics also has partnerships with Harvard Medical School, Geisinger Health System in Pennsylvania, and the New England Baptist Hospital.