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  4. Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial

Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial

Neural Regen Res, 2020 · DOI: 10.4103/1673-5374.274347 · Published: January 28, 2020

Spinal Cord InjuryRegenerative MedicineResearch Methodology & Design

Simple Explanation

This study explores using stem cells from umbilical cords (hUC-MSCs) to help people with spinal cord injuries. These stem cells may help by supporting blood vessel regrowth, reducing inflammation, preventing cell death, and releasing helpful substances. The study focuses on people with spinal cord injuries in the 'early chronic' phase, meaning they were injured between 2 months and 1 year ago. This is a common timeframe, but there aren't many studies on treatments during this phase. The trial involves multiple hospitals and will randomly assign participants to receive either the stem cell treatment or a placebo (normal saline). Neither the doctors giving the therapy nor the evaluators will be blinded, but the patients themselves will not know which treatment they are receiving.

Study Duration
12 months
Participants
66 early chronic SCI patients
Evidence Level
Level 1: Prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial

Key Findings

  • 1
    The primary goal is to see if hUC-MSCs can improve the ASIA (American Spinal Injury Association) total score in patients with early chronic SCI.
  • 2
    The study will also measure other outcomes like muscle tension, electromyogram results, and changes seen on MRI scans to assess the treatment's effectiveness.
  • 3
    The clinical trial is designed to evaluate the safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.

Research Summary

This study protocol outlines a clinical trial to investigate the use of human umbilical cord mesenchymal stem cells (hUC-MSCs) for treating spinal cord injury (SCI) in the early chronic phase. The trial is designed as a prospective, multicenter, randomized, placebo-controlled, single-blinded study involving 66 patients with early chronic SCI. The primary outcome measure is the change in the American Spinal Injury Association (ASIA) total score, with secondary outcomes including various functional assessments, imaging evaluations, and humoral indicators.

Practical Implications

Potential New Therapy for SCI

If successful, this study could provide a new therapeutic option for patients with early chronic SCI, a population for whom effective treatments are currently lacking.

Improved Quality of Life

The study aims to improve motor, sensory, and micturition/defecation function in patients, potentially leading to a better quality of life.

Cost Savings

The study suggests that if hUC-MSC transplantation proves effective, it may reduce the need for other expensive and mostly ineffective therapies, leading to substantial cost savings.

Study Limitations

  • 1
    The study is single-blinded, which may introduce bias.
  • 2
    The assessors will not be intervention-blinded.
  • 3
    The study relies on specific inclusion and exclusion criteria, which may limit the generalizability of the results.

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