Safety and feasibility of intravenous administration of a single dose of allogenic‑Muse cells to treat human cervical traumatic spinal cord injury: a clinical trial

Stem Cell Research & Therapy, 2024 · DOI: https://doi.org/10.1186/s13287-024-03842-w · Published: July 11, 2024

Spinal Cord Injury Regenerative Medicine Research Methodology & Design

Simple Explanation

This study explores using a special kind of stem cell, called Muse cells, to help people with spinal cord injuries. These Muse cells are given through a vein (intravenously) to see if it's safe and if it can improve their condition. The main goal was to check for safety, but they also looked for any signs of improvement in how well the patients could move and function.

Study Duration

52 weeks

Participants

10 (8 males, 2 females) with cervical SCI

Evidence Level

Level I, prospective, multicenter, nonrandomized, nonblinded, single-arm study

Key Findings

1
The study found no serious safety issues with using Muse cells in this way.
2
Patients showed improvements in their motor skills, sensory perception, and daily activities after the treatment.
3
The patients' perception of their health also improved significantly after 12 weeks.

Research Summary

This clinical trial investigated the safety and feasibility of intravenous administration of allogenic Muse cells for treating human cervical traumatic spinal cord injury (SCI). The study involved 10 participants with cervical SCI and modified Frankel classification B1/B2, who received a single dose of allogenic Muse cells. The results indicated that the Muse cell transplantation demonstrated good tolerability and no safety concerns were identified.

Practical Implications

Treatment Potential

Muse cell therapy may offer a safe and feasible treatment option for individuals with cervical traumatic spinal cord injury, potentially leading to improvements in motor function, sensory perception, and activities of daily living.

Future Research

Further research, including controlled clinical trials, is warranted to confirm the efficacy of Muse cell therapy and optimize treatment protocols for SCI.

Clinical Practice

These findings support the continued exploration of cell-based therapies for SCI and may influence the development of clinical guidelines for regenerative medicine approaches in this patient population.

Study Limitations

1
The present study was conducted by a single-arm design without setting control subjects.
2
Definitive conclusions on efficacy cannot be clearly drawn.
3
It is impossible to compare directly with historical data because no appropriate historical control data for motor/sensory and ADL/QOL recovery are generally available.

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