Case reportCELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue–Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury
Section snippets
Study Patient
The patient is a 53-year-old male who suffered a surfing accident resulting in a C3-4 SCI. Neurologic examination at the time of the accident revealed complete loss of motor and sensory function below the level of injury along with loss of bowel and bladder sensation. Accordingly, the individual was diagnosed with an American Spinal Injury Association (ASIA) grade A SCI, and underwent a C2-6 posterior cervical decompression and fusion. Postoperatively, improvement in motor and sensory function
Safety and Adverse Events
The patient tolerated the procedure well and did not experience any severe adverse events related to the injection. He reported a mild to moderate headache on day 2, which resolved with acetaminophen. Throughout the 18-month follow-up, no other safety issues or adverse events were reported.
ASIA Motor Score
The total upper extremity motor score progressively improved from 35 at baseline to 44 at 18 months, with more marked improvement on the right (19 at baseline to 25 at 18 months) compared with the left side
Discussion
Spinal cord injury has a complex pathophysiology. One of the more challenging aspects of this life altering pathophysiology is the onset of secondary mechanisms of tissue insult in the subacute and chronic phase following the primary injury. Glial scarring limits axonal regeneration as a complex physicochemical barrier by secreting growth inhibitor molecules. These microenvironmental changes cause the chronically injured spinal cord to be in a refractory state.11 In addition to bridging the
Conclusion
Intrathecal AD-MSC administration may have the potential to improve neurologic function in patients with plateaued clinical improvement following SCI. Further clinical translation of this therapeutic strategy would require demonstration of treatment safety and efficacy in a sufficiently powered randomized controlled trial and identification of prognostic factors predictive of response to intervention.
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2023, Chemical Engineering JournalCitation Excerpt :CELLTOP study (NCT03308565) carried out by Mayo Clinic delineated a 53-year-old patient with grade A spinal cord injury (evaluated by American Spinal Injury Association Impairment Scale). When conventional therapy failed to make further progress, his neurologic status showed marked recovery after receiving intrathecal administration of autologous ASCs [198]. These phenomena indicated that ASCs transplantation is a novel clinical intervention modality with superior therapeutic capacity, carving out an area that is hard to reach with traditional means.
Late toxicities management
2023, Palliative Radiation OncologyClinical cell therapy guidelines for neurorestoration (IANR/CANR 2022)
2022, Journal of Neurorestoratology
For editorial comment, see page 224
Grant Support: This work was supported by grants from Regenerative Medicine Minnesota and Mayo Clinic Transform the Practice.
Potential Competing Interests: Dr Terzic is a member of the board for Rion, LLC. The other authors report no competing interests.