StemCell Therapy

May 23, 2024

Mayo Clinic researchers have demonstrated the safety and potential benefit of stem cell regenerative medicine therapy for patients with subacute and chronic spinal cord injury.

The results of the phase 1 Clinical Trial of Autologous Adipose-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury, known as CELLTOP, were published in Nature Communications.

Illustration shows the process of fat harvest via biopsy, adipose-derived mesenchymal stem cells (AD-MSC) preparation and administration of treatment.

All trial participants had experienced traumatic spinal injury classified as grade A or B on the American Spinal Injury Association Impairment Scale (AIS). Stem cell treatment was initiated on average 11 months after injury. Participants were evaluated over a two-year period.

Key findings:

As reported earlier in Mayo Clinic Proceedings, the first participant in the phase 1 trial was a superresponder who, after stem cell therapy, saw significant improvements in the function of his upper and lower extremities.

"Future research may show whether stem cells in combination with other therapies could be part of a new paradigm of treatment to improve outcomes for patients," says Mohamad Bydon, M.D., a neurosurgeon at Mayo Clinic in Rochester, Minnesota, and the first author of both studies. "Not every patient who receives stem cell treatment is going to be a superresponder. One objective in our future studies is to delineate the optimal treatment protocols and understand why patients respond differently."

Dr. Bydon notes that stem cells' mechanism of action isn't fully understood. The researchers are analyzing changes in participants' MRI and cerebrospinal fluid to identify avenues for potential regeneration. Work is also underway on a larger, controlled trial of stem cell regenerative therapy.

"For years, treatment of spinal cord injury has been limited to stabilization surgery and physical therapy," Dr. Bydon says. "Many historical textbooks state that this condition does not improve. We have seen findings in recent years that challenge prior assumptions. This research is a step forward toward the ultimate goal of improving treatments for patients."

Bydon M, et al. Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury: Phase I trial. Nature Communications. 2024;15:2201.

Bydon M, et al. CELLTOP clinical trial: First report from a phase I trial of autologous adipose tissue-derived mesenchymal stem cells in the treatment of paralysis due to traumatic spinal cord injury. Mayo Clinic Proceedings. 2020;95:406.

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