Biomanufacturing Breakthrough: How Scalable Treatments Could Impact Spinal Cord Injury Litigation

Spinal cord injuries (SCIs) are devastating, affecting over 20 million individuals worldwide and leading to significant physical, psychological, and economic burdens. Current treatments offer limited functional recovery, leaving many with lifelong disabilities. The Christopher and Dana Reeve Foundation estimates that high tetraplegia can cost over $1 million in the first year alone, with subsequent annual expenses averaging $171,808. However, recent breakthroughs in biomanufacturing offer new hope, potentially revolutionizing SCI treatment and, consequently, impacting spinal cord injury litigation.

Understanding Spinal Cord Injuries

A spinal cord injury results from damage to the vertebrae or discs, causing compression or direct damage to the spinal cord. This damage disrupts the spinal cord’s role as an “information superhighway,” instantly disrupting information transmission and making repair extremely challenging. The primary injury, often caused by traumatic events like car accidents or falls, is followed by a secondary injury, characterized by inflammation and cell damage. This complex cascade of events leads to the degeneration of nerve cells and the formation of scar tissue, hindering functional recovery.

The Promise of Biomanufacturing

Biomanufacturing, the production of biological molecules and materials on a commercial scale, is emerging as a game-changer in regenerative medicine. It offers the potential to create scalable, personalized treatments for SCI, addressing the limitations of traditional approaches.

One promising avenue involves using stem cells to repair damaged neural tissue. Different types of stem cells, including embryonic stem cells (ESCs), induced pluripotent stem cells (iPSCs), mesenchymal stem cells (MSCs), and neural stem/progenitor cells (NSPCs), are being explored for their regenerative potential. For example, iPSCs, derived from a patient’s own cells, can be differentiated into various neural cell types, offering a personalized approach to SCI treatment.

Key Players and Innovative Technologies

Several companies and research institutions are at the forefront of biomanufacturing for SCI:

Cellino and Matricelf: These companies are collaborating to scale personalized SCI treatments using Cellino’s Nebula™ technology, an AI-driven biomanufacturing platform for iPSCs, combined with Matricelf’s 3D differentiation process. This collaboration aims to create patient-specific regenerative therapies, with Matricelf planning to file an Investigational New Drug (IND) application to begin clinical trials.
NervGen Pharma: This clinical-stage biotech company is developing innovative treatments to enable nervous system repair after traumatic injury and disease. Their lead drug candidate, NVG-291, is currently in Phase 1b/2a clinical trials for SCI.
NovaGo Therapeutics: This Swiss biotech company focuses on human antibody therapeutics targeting nerve growth and regeneration to enhance functional recovery following SCI. They have initiated Phase 1b clinical trials for their therapeutic antibody candidate, NG004.
NurExone Biologic Inc.: This biopharmaceutical company is developing biologically-guided exosome therapy for patients with traumatic SCI. They are collaborating with Inteligex Inc. to develop therapies for chronic SCI, supported by a grant from the Israel-Canada bilateral Eureka program.
Lineage Cell Therapeutics, Inc.: This company has initiated the DOSED clinical study to evaluate the safety and utility of a novel delivery device for their cell therapy, OPC1, in patients with SCI.

Other innovative technologies being explored include:

3D Bioprinting: This technology allows for the precise printing of complex structures, blending cells and cytokines to create biological scaffolds that promote tissue regeneration.
Biomaterials: Researchers are developing biomaterials that can reduce inflammation, promote nerve regeneration, and serve as bridges for growing nerve fibers across the injury site. For example, researchers at the University of British Columbia are working on a soft gel containing magnetic rods to guide nerve fiber growth.
Gene Therapy: This approach involves using viral vectors to deliver therapeutic genes to the spinal cord, promoting nerve regeneration and reducing inflammation. UTHealth Houston is conducting a clinical trial using a modified herpes virus to treat neurogenic bladder in SCI patients.

Challenges and Considerations

Despite the promise of biomanufacturing, several challenges remain:

Complexity of SCI: The multifaceted nature of SCI, involving primary and secondary injuries, makes it difficult to develop effective treatments.
Limited Nerve Regeneration: The limited regenerative capacity of nerve cells and the formation of scar tissue hinder functional recovery.
Clinical Trial Difficulties: Clinical trials for SCI treatments are complex and expensive, requiring long time periods to assess efficacy due to the slow speed of nerve regeneration.
Ethical Considerations: Stem cell therapy raises ethical concerns, particularly regarding the use of embryonic stem cells and the potential for adverse events.
Regulatory Standards: The development and implementation of appropriate regulatory standards are crucial to ensure the ethical and safe practice of biomanufacturing for SCI.

Impact on Spinal Cord Injury Litigation

The emergence of biomanufacturing breakthroughs has the potential to significantly impact SCI litigation:

Increased Hope for Recovery: As biomanufactured treatments become more effective, individuals with SCI may experience improved functional outcomes, potentially reducing the long-term impact of their injuries.
Changing Standards of Care: The development of new treatments may lead to changes in the standard of care for SCI, potentially affecting liability in negligence cases.
Valuation of Damages: The availability of effective treatments may influence the valuation of damages in SCI cases, as the cost of long-term care and lost earnings may be offset by the potential for functional recovery.
New Avenues for Litigation: If biomanufactured treatments cause adverse effects, new avenues for litigation may arise, such as product liability claims against manufacturers.

Legal Considerations

In spinal cord injury cases, several legal bases may apply, including negligence, product liability, and premises liability. Negligence, the most common basis, involves proving that the defendant failed to exercise reasonable care, resulting in the plaintiff’s injury. A spinal cord injury lawyer can advise you as to the specific value of your case and the compensation rights to which your spinal cord injury has entitled you.

Compensation in SCI cases may cover medical expenses, lost income, caregiving costs, and pain and suffering. The availability of insurance coverage and other forms of compensation, such as Social Security Disability benefits, may also impact the outcome of litigation.

Moving Forward

Biomanufacturing holds immense promise for revolutionizing SCI treatment and improving the lives of millions affected by this devastating condition. As these technologies continue to advance, it is crucial to address the challenges and ethical considerations associated with their development and implementation. Moreover, the legal landscape surrounding SCI litigation may evolve as new treatments emerge, requiring careful consideration of the potential impact on liability, damages, and standards of care.