Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury: Phase I trial

Nature Communications, 2024 · DOI: 10.1038/s41467-024-46259-y · Published: March 6, 2024

Spinal Cord Injury Regenerative Medicine

Simple Explanation

This study explores using stem cells from fat tissue to treat spinal cord injuries. These stem cells, called adipose-derived mesenchymal stem cells (AD-MSCs), are injected into the spinal fluid. The main goal was to check if this treatment is safe. The study also looked for any improvements in patients' sensory and motor functions. The study found that the treatment was generally well-tolerated. Some patients showed improvements in their condition after the treatment.

Study Duration

January 2018 to October 2021

Participants

10 patients with American Spinal Injury Association Impairment Scale (AIS) grade A or B at the time of injury

Evidence Level

Level I, Phase I clinical trial

Key Findings

1
The study demonstrated that AD-MSC harvesting and administration were well-tolerated in patients with traumatic SCI.
2
Seven patients demonstrated improvement in AIS grade from the time of injection.
3
The most commonly reported adverse events were headache and musculoskeletal pain.

Research Summary

This Phase I clinical trial demonstrates the safety of intrathecal administration of culture-expanded 1 × 108 cells of autologous AD-MSCs for patients with traumatic SCI. Stem cells were successfully manufactured, and products were delivered to all enrolled patients. No serious adverse events occurred throughout the study period, although non-serious adverse events were not infrequent. At the ﬁnal follow-up, seven of the ten patients experienced an improvement in AIS grade compared to their pre-injection status.

Practical Implications

Safety of AD-MSC Injection

The study establishes a safety profile for intrathecal AD-MSC injection, warranting further investigation into its impact on neurological outcomes.

Potential for Neurological Improvement

Observed improvements in AIS grade and motor/sensory function suggest a potential therapeutic benefit of AD-MSC injection in spinal cord injury patients.

Future Research Directions

The findings call for larger randomized controlled trials with comprehensive clinimetric tools to confirm the benefits of AD-MSC injections in late-stage neurological recovery for SCI.

Study Limitations

1
Phase I clinical trials have intrinsic limitations.
2
Drawbacks of the AIS grading have also been previously recognized
3
The absence of controls prevents ascribing the observed neurological improvement solely to the administration of AD-MSCs.

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