Breakthrough Therapies: A Look at Spinal Cord Injury Clinical Trials in 2025
Spinal cord injuries (SCI) affect approximately 54 cases per one million people annually, leaving over 300,000 individuals in the United States living with the condition. For too long, those living with SCI have been told that recovery lies beyond the horizon of possibility. However, 2025 is shaping up to be a year of unprecedented momentum in SCI research, with several breakthrough therapies and clinical trials offering new hope for improved function and quality of life.
The Current State of Spinal Cord Injury Treatment
Currently, there is no definitive cure for SCI. Emergency care focuses on stabilizing the patient, preventing further damage, and maximizing function. Treatments often include:
- Immobilization of the spine
- Reducing inflammation
- Surgery to repair fractures or relieve pressure
- Rehabilitation, including physical and occupational therapy
- Assistive devices like wheelchairs and braces
While these treatments are crucial for managing the condition, they do not reliably restore full spinal cord function. However, the landscape is changing rapidly, with experimental therapies like stem cells and robotic devices showing promise.
Breakthrough Therapies and Clinical Trials in 2025
Several cutting-edge therapies and clinical trials are making headlines in 2025, offering renewed hope for individuals with SCI.
1. ARC-EX® System
ONWARD Medical’s ARC-EX® System received FDA approval as the first-ever technology developed specifically for the SCI community. This non-invasive spinal cord stimulation system is designed for people with chronic SCI. A UK study showed that improvements resulting from ARC-EX Therapy extend for at least one year, with no observed plateau. The Company plans to seek CE Mark certification to commercialize the ARC-EX System in Europe in 2025.
2. Nasal Cell Therapy
Griffith University has commenced a Phase 1 human clinical trial using nasal cells to treat chronic SCI. This world-first trial involves taking olfactory ensheathing cells from the nose, which have therapeutic properties for repairing and regenerating nerves. The cells are used to create a nerve bridge implanted into the spine at the injury site. Patients undergo intensive rehabilitation before and after transplantation to stimulate regeneration.
3. Vagus Nerve Stimulation (VNS)
Researchers at the Texas Biomedical Device Center at The University of Texas at Dallas demonstrated unprecedented rates of recovery for SCI using closed-loop vagus nerve stimulation (CLV). This approach combines stimulation of a nerve in the neck with progressive, individualized rehabilitation, resulting in meaningful improvements in arm and hand function. The scientists are proceeding with a pivotal trial, the final hurdle before potential FDA approval of VNS for upper-limb impairment due to SCI.
4. Spinal Cord Replacement
In Israel, Tel Aviv University is preparing to perform the world’s first human spinal cord implant using a patient’s own cells. This procedure involves replacing the damaged section with a lab-grown spinal cord that fuses with healthy tissue. Animal studies in rats have shown remarkable results, with the animals regaining the ability to walk normally.
5. XellSmart’s iPSC Regenerative Therapy
XellSmart Biopharmaceutical has received approval from both the FDA and China’s National Medical Products Administration to commence Phase I clinical trials for their allogeneic induced pluripotent stem cells (iPSC) regenerative therapy. This therapy aims to replace damaged or dead neural cells caused by SCI, with the goal of not just repairing the injury but providing the foundation to regrow all the cells needed to return function to the damaged region.
6. “Dancing Molecules”
Northwestern University has developed a one-time, injectable therapy that sends signals to damaged and severed cells to encourage them to regenerate or proliferate. After a single injection, paralyzed animals with severe spinal cord injuries regained the ability to walk within just four weeks. Amphix Bio is targeting late 2026 for the first trials in spinal cord injury patients and is now completing safety studies required for regulatory approval to begin human trials.
7. NervGen’s NVG-291
NVG-291, a medication designed to help repair damaged nerves, is currently being tested in a Phase 1b/2a trial. The study is carefully designed to see how well the drug works by comparing it to a placebo, and it will track things like movement, nerve signals, and other signs of improvement. Initial results for those with longer-term injuries are expected around the middle of 2025.
8. STEMIRAC
STEMIRAC, developed by Nipro Corporation, is an autologous mesenchymal stem cell (MSC) therapy aimed at treating traumatic spinal cord injury. The treatment process involves extracting MSCs from the patient’s bone marrow, expanding them in vitro, and cryopreserving them for future administration. It is expected to achieve full approval by December 2025, offering new treatment possibilities for SCI patients.
9. MT-3921
MT-3921, developed by Mitsubishi Tanabe Pharma Corporation (MTPC) in partnership with Osaka University, is designed to treat spinal cord injury. By inhibiting repulsive guidance molecule A (RGMa), a key factor that suppresses neuronal survival and regeneration, MT-3921 aims to enhance neuroregeneration and restore motor function in SCI patients. A Phase II Proof-of-Concept trial, launched in September 2021, is assessing MT-3921’s effectiveness in 72 SCI patients across clinical sites in the United States and Japan.
The Importance of Clinical Trials
Clinical trials are essential for evaluating the safety and efficacy of new SCI treatments. These trials help researchers understand how different therapies work, identify potential side effects, and determine which treatments are most effective for specific types of injuries. With over 1,100 SCI trials happening around the world right now, significant progress is being made in understanding the nervous system, exploring ways to heal, and developing helpful technologies.
Navigating the Legal Landscape of Spinal Cord Injuries
Spinal cord injuries often result from traumatic events such as car accidents, falls, or workplace incidents. If your injury was caused by someone else’s negligence, you may be entitled to compensation for your medical expenses, lost wages, and other damages. Consulting with a personal injury attorney experienced in SCI cases can help you understand your legal rights and options. An attorney can investigate the circumstances of your injury, gather evidence to support your claim, and negotiate with insurance companies to reach a fair settlement. If a settlement cannot be reached, your attorney can represent you in court to pursue the compensation you deserve.
The Future of Spinal Cord Injury Treatment
The advancements in SCI research and treatment are providing new hope for individuals living with paralysis. As these breakthrough therapies move through clinical trials and become more widely available, the potential for improved function and quality of life is greater than ever before. The combination of innovative treatments, intensive rehabilitation, and strong legal advocacy offers a comprehensive approach to addressing the challenges of spinal cord injuries and empowering individuals to live full and meaningful lives.
If you or a loved one has suffered a spinal cord injury, it is crucial to stay informed about the latest treatment options and legal rights. Contact our firm today for a consultation to discuss your case and explore your options for recovery.