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Review
. 2022 Mar 17;11(6):1019.
doi: 10.3390/cells11061019.

Clinical Trials Using Mesenchymal Stem Cells for Spinal Cord Injury: Challenges in Generating Evidence

Lila Teixeira de Araújo  1   2 , Carolina Thé Macêdo  1   3 , Patrícia Kauanna Fonseca Damasceno  1   2 , Ítalo Gabriel Costa das Neves  1 , Carla Souza de Lima  1 , Girlaine Café Santos  1   2 , Thaís Alves de Santana  1   2 , Gabriela Louise de Almeida Sampaio  1   2 , Daniela Nascimento Silva  1   4 , Cristiane Flora Villarreal  2   5 , Alessandra Casemiro de Campos Chaguri  1 , Crislaine Gomes da Silva  1 , Augusto César de Andrade Mota  6 , Roberto Badaró  1 , Ricardo Ribeiro Dos Santos  1   2 , Milena Botelho Pereira Soares  1   2
Affiliations
Review

Clinical Trials Using Mesenchymal Stem Cells for Spinal Cord Injury: Challenges in Generating Evidence

Lila Teixeira de Araújo et al. Cells. .

Abstract

Spinal cord injury (SCI) remains an important public health problem which often causes permanent loss of muscle strength, sensation, and function below the site of the injury, generating physical, psychological, and social impacts throughout the lives of the affected individuals, since there are no effective treatments available. The use of stem cells has been investigated as a therapeutic approach for the treatment of SCI. Although a significant number of studies have been conducted in pre-clinical and clinical settings, so far there is no established cell therapy for the treatment of SCI. One aspect that makes it difficult to evaluate the efficacy is the heterogeneity of experimental designs in the clinical trials that have been published. Cell transplantation methods vary widely among the trials, and there are still no standardized protocols or recommendations for the therapeutic use of stem cells in SCI. Among the different cell types, mesenchymal stem/stromal cells (MSCs) are the most frequently tested in clinical trials for SCI treatment. This study reviews the clinical applications of MSCs for SCI, focusing on the critical analysis of 17 clinical trials published thus far, with emphasis on their design and quality. Moreover, it highlights the need for more evidence-based studies designed as randomized controlled trials and potential challenges to be addressed in context of stem cell therapies for SCI.

Keywords: clinical trial; mesenchymal stem cells; mesenchymal stromal cells; spinal cord injury.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Data search strategies for clinical trials about MSCs in SCI.
Figure 2
Figure 2
Intensity of adverse events reported (n = 13) in 17 clinical studies.
Figure 3
Figure 3
Sample size and country distribution of clinical studies reviewed.
Figure 4
Figure 4
Potential factors influencing MSCs’ efficacy in SCI.
Figure 5
Figure 5
Clinically significant outcomes observed after MSC therapy in SCI, considering the domains of body structures and functions.
Figure 6
Figure 6
Clinically significant outcomes after MSC therapy in SCI, considering the domains activity, participation, and performance.
Figure 7
Figure 7
Quality criteria for conducting clinical trials: follow-up, matching, randomization, and blinding.
Figure 8
Figure 8
Quality criteria for conducting clinical trials: MSCs details, associated interventions, and CT registry.
Figure 9
Figure 9
Types of quality control tests performed during stem cell manufacturing in the reviewed clinical trials on SCI.
Figure 10
Figure 10
Number of quality control tests performed in the clinical trials on SCI.
Figure 11
Figure 11
General qualifiers for MSC clinical trials on SCI: a summary of important points of care: methodology, ethics, good clinical and manufacturing practices and outcomes. Each variable can contribute to the performing of a good quality trial using MSCs for spinal injuries.
Figure 12
Figure 12
Overview of the main contributions of this article to perform good quality clinical trials in SCI: research, importance, benefits, results expectation, innovation, challenges and mitigation strategies.
See this image and copyright information in PMC

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