A promising treatment for acute spinal cord injuries developed at Northwestern University has received Orphan Drug Designation from the FDA. This therapy, known as "dancing molecules," utilizes molecular motion to repair tissue and reverse paralysis. In preclinical trials, a single injection helped mice regain the ability to walk within four weeks. Amphix Bio, which emerged from Stupp's laboratory, is managing the regulatory process and plans to initiate human trials for acute spinal cord injuries in late 2026. The therapy has shown the potential to regenerate neural tissue in various models and conditions.
"Dancing molecules," the promising new treatment for acute spinal cord injuries developed at Northwestern University, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA).
A one-time injection administered 24 hours after severe injury helped mice regain the ability to walk - just four weeks after treatment.
Amphix Bio is helping navigate the FDA approval process and is targeting late 2026 for the first trials in spinal cord injury patients.
Since we first published our results in 2021, we have validated the ability of these molecules to regenerate functional neural tissue in new animal models.
#spinal-cord-injury #regenerative-medicine #fda-orphan-drug-designation #nanomedicine #clinical-trials
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