A Mayo Clinic investigation demonstrates the safety and potential therapeutic benefits of using stem cells derived from patients’ own fat to potentially enhance sensation and movement following traumatic spinal cord injuries. The results of this Phase I clinical trial, published in Nature Communications, shed light on the promise of cell therapy for individuals living with spinal cord injuries, offering hope where treatment options are limited.
The study, involving 10 adults, observed improvements in seven participants based on the American Spinal Injury Association (ASIA) Impairment Scale. These improvements included heightened sensation to pinprick and light touch, enhanced muscle strength, and the restoration of voluntary anal contraction crucial for bowel function. Notably, each of the seven participants who demonstrated improvement moved up at least one level on the ASIA scale, while three patients showed no response, neither improving nor worsening.
Dr. Mohamad Bydon, a Mayo Clinic neurosurgeon and the study’s lead author, underscores the significance of the findings, emphasizing the safety and potential therapeutic effects of stem cells and regenerative medicine in spinal cord injury treatment. He highlights the complexity of spinal cord injury and hints at future research exploring the combined use of stem cells with other therapies to enhance patient outcomes.
The study reports no serious adverse events following stem cell treatment, with minor side effects such as headache and musculoskeletal pain being transient and manageable with over-the-counter medications. While the trial primarily focused on safety, it also assessed changes in motor and sensory function, with caution urged in interpreting results due to the inherent limitations of Phase I trials. Further research involving a larger cohort is ongoing to comprehensively evaluate risks and benefits.
Stem cells were extracted from participants’ fat tissue through minimally invasive procedures and subsequently expanded in the laboratory before being injected into the lumbar spine over a period of four weeks. The trial spanned two years, during which participants underwent regular evaluations to track progress.
While the mechanism by which stem cells interact with the spinal cord is not fully understood, researchers analyzed various parameters, including MRIs and cerebrospinal fluid, alongside sensory responses, to unravel potential regeneration pathways. The trial yielded unexpected outcomes, with some participants exhibiting improvements even months after injury, challenging conventional assumptions regarding spinal cord injury recovery.
Moving forward, research into stem cell therapies for spinal cord injuries aims to determine efficacy in specific patient subsets, with ongoing investigations including larger controlled trials. Dr. Bydon emphasizes the shift away from traditional supportive care toward innovative treatments, marking a significant stride in spinal cord injury management.