Breakthrough in Spinal Cord Injury Treatment: Shize Biotech’s Universal iPSC-Derived Cell Therapy Enters Global Clinical Trials

Spinal Cord Injury: A Global Medical Challenge

Spinal cord injury (SCI) is a devastating neurological disorder characterized by permanent damage to motor and sensory functions, often resulting in paralysis. Common causes include trauma (e.g., accidents or falls) and degenerative conditions. Patients may experience partial or complete loss of limb movement, bladder/bowel dysfunction, and chronic pain, with lifelong dependency on rehabilitation and care.

Globally, approximately 15 million people live with SCI, including over 3 million in China, where 100,000 new cases are reported annually. The socioeconomic burden is immense: lifetime healthcare costs in high-income countries exceed $1 million per patient, compounded by reduced workforce participation and mental health challenges.

Shize Biotech: Pioneering Universal iPSC-Derived Cell Therapies

Founded in 2021 by Dr. Xiang Li, a veteran in induced pluripotent stem cell (iPSC) research, Shize Biotech (Suzhou) has emerged as a leader in developing “off-the-shelf” allogeneic iPSC-derived cell therapies for central nervous system (CNS) disorders. The company’s mission targets diseases like Parkinson’s, amyotrophic lateral sclerosis (ALS), and SCI—conditions with limited treatment options.

The “Off-the-Shelf” iPSC-Derived Neural Progenitor Cell Therapy

Shize’s flagship product leverages clinical-grade iPSCs differentiated into subtype-specific neural progenitor cells. These cells are designed to replace damaged neurons, promote neural regeneration, and restore functional connectivity in SCI patients. Preclinical studies demonstrated efficacy in animal models, showing improved motor recovery and reduced inflammation.

Clinical Progress and Regulatory Milestones

In May 2025, Shize secured approvals from both China’s NMPA and the U.S. FDA to initiate Phase I/II trials for SCI treatment—a global first for iPSC-derived therapies in this indication. Collaborating with top-tier hospitals like Sun Yat-sen University’s Third Affiliated Hospital, the trials aim to evaluate safety and efficacy in patients with acute-to-subacute injuries. This builds on prior successes: in 2023, their ALS therapy became the first Chinese iPSC-derived drug granted FDA orphan drug designation, securing 7-year market exclusivity post-approval.

A Legacy of Innovation in CNS Therapeutics

Since its inception, Shize has focused on overcoming the unique challenges of CNS drug development. Key achievements include:

2021–2023: Established a 5,000 m² R&D and GMP facility, enabling scalable production of clinical-grade iPSC lines.
2024: Completed China’s first national-filing clinical study for Parkinson’s disease, demonstrating sustained symptom improvement in patients over 12 months.
2025: Expanded its pipeline to five investigational therapies, all undergoing U.S.-China dual regulatory pathways.

Supported by prominent investors (e.g., Sequoia Capital, Lilly Asia Ventures), Shize exemplifies China’s growing influence in cutting-edge biotech, blending academic rigor with industrial scalability.

Conclusion: Toward a New Era in Regenerative Medicine

Shize Biotech’s SCI therapy represents a paradigm shift—from palliative care to regenerative repair. While challenges remain (e.g., long-term safety, immune compatibility), their progress underscores the potential of iPSC technologies to address unmet needs in neurology. As trials advance, the global medical community watches closely, hopeful for a future where paralysis is no longer a life sentence.