Mesenchymal Stromal/Stem Cells in Chronic Incomplete Traumatic Spinal Cord Injury: A Phase I/II Double-Blind...

Area of Science:

• Neuroscience
• Regenerative Medicine
• Clinical Trials

Background:

• Chronic spinal cord injury (SCI) leads to lasting neurological deficits.
• Current treatments for SCI lack regenerative efficacy.
• Mesenchymal stromal cells (MSCs), especially WJ-MSCs, show promise for neuroprotection and immunomodulation.

Purpose of the Study:

• To assess the safety and efficacy of intrathecal allogeneic WJ-MSC administration.
• To evaluate WJ-MSCs in patients with chronic incomplete cervical SCI.
• To compare WJ-MSC treatment against a placebo in a randomized controlled trial.

Main Methods:

• A multicenter, randomized, double-blind, placebo-controlled trial (NCT05054803).
• 18 participants with chronic incomplete cervical SCI received two intrathecal WJ-MSC injections or placebo.
• Outcomes included safety, neurological scores (ISNCSCI), spasticity, pain, function, and quality of life over 12 months.

Main Results:

• Intrathecal WJ-MSC administration was safe and well-tolerated.
• No significant between-group differences in motor or sensory scores were observed at 12 months.
• Adverse events were mostly mild/moderate and unrelated to treatment.

Conclusions:

• Intrathecal WJ-MSCs show a favorable safety profile for chronic incomplete cervical SCI.
• This trial did not detect significant efficacy differences compared to placebo.
• Future research needs larger samples, optimized delivery, and combination therapies.