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A novel randomized, double-blind, placebo-controlled
trial to be initiated for acute traumatic spinal cord injury (SCI) treatment.
As announced by a bio-medical device company on 19th August 2020, a breakthrough multi-centre, randomized, double-blind, placebo-controlled trial for the treatment of acute traumatic spinal cord injury (SCI) will be initiated in 13 hospitals in Austria and 1 in Germany, over the coming 2 years.
The primary endpoint would examine if indistinct electro-hydraulic shockwaves can attain a statistically noteworthy improvement in motor and sensory function (as per the AIS grade) for acute SCI if used in 3 days of the injury. Pain, ability to walk, quality of life, and daily independence will be distinguished concerning time in each group of this trial. Activation of stem cell, lessening in apoptosis, neovascularization, and, most notably, inflammatory response reduction after the injury might be hypothesized mode of action linked with the betterment of the clinical outcomes.
Even after the stability of the injury, swelling/inflammation following spine trauma may interrupt the remaining feasible spinal cord function as per medical research. Swelling can exacerbate SCI patients in the initial hours and days after the trauma. Shock wave treatment considerably eases swelling, providing faith to SCI patients, if useful timely after an injury. If used within hours of an injury, it may decrease the degree of paralysis. The treatment significantly lessens inflammation and it also instigates a robust biologic cascade, comprising of stimulation of stem cell and process of assembly of new vascular structures (neovascularization).
CISION- PR Newswire
Softwave® Tissue Regeneration Technologies Announces Landmark Trial for Acute Traumatic Spinal Cord Injuries
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