Safety and neurological assessments after autologous transplantation of bone marrow mesenchymal stem cells in subjects with chronic spinal cord injury

Introduction The administration of stem cells holds promise as a potential therapy for spinal cord injury (SCI). Mesenchymal stem cells have advantages for clinical applications, since they can be easily obtained, are suitable for autologous transplantation and have been previously shown to induce r...

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Veröffentlicht in:Stem cell research & therapy Jg. 5; H. 6; S. 126
Hauptverfasser: Mendonça, Marcus Vinícius Pinheiro, Larocca, Ticiana Ferreira, de Freitas Souza, Bruno Solano, Villarreal, Cristiane Flora, Silva, Luiz Flávio Maia, Matos, André Costa, Novaes, Marco Antonio, Bahia, Cláudia Maria Pinheiro, de Oliveira Melo Martinez, Ana Carine, Kaneto, Carla Martins, Furtado, Sissi Brandão Carneiro, Sampaio, Geraldo Pedral, Soares, Milena Botelho Pereira, dos Santos, Ricardo Ribeiro
Format: Journal Article
Sprache:Englisch
Veröffentlicht: London BioMed Central 17.11.2014
BioMed Central Ltd
Schlagworte:
Adult
Biomedical and Life Sciences
Biomedical Engineering and Bioengineering
Cell Biology
Cells, Cultured
Chromosomes
Evoked Potentials, Somatosensory
Female
Health aspects
Humans
Life Sciences
Male
Mesenchymal Stem Cell Transplantation - adverse effects
Mesenchymal Stromal Cells - cytology
Mesenchymal Stromal Cells - metabolism
Middle Aged
Regenerative Medicine/Tissue Engineering
Safety and security measures
Spinal Cord Injuries - therapy
Stem cell research
Stem Cells
Transplantation, Autologous - adverse effects
Detrusor Overactivity
Injured Spinal Cord
Visual Analogue Score
Mesenchymal Stem Cell
Spinal Cord Injury
ISSN:1757-6512, 1757-6512
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Zusammenfassung:Introduction The administration of stem cells holds promise as a potential therapy for spinal cord injury (SCI). Mesenchymal stem cells have advantages for clinical applications, since they can be easily obtained, are suitable for autologous transplantation and have been previously shown to induce regeneration of the spinal cord in experimental settings. Here we evaluated the feasibility, safety and potential efficacy of autologous transplantation of mesenchymal stem cells in subjects with chronic complete SCI. Method We conducted a phase I, non-controlled study in 14 subjects of both genders aging between 18 to 65 years, with chronic traumatic SCI (>6 months), at thoracic or lumbar levels, classified as American Spinal Injury Association (ASIA) A - complete injury. Baseline somatosensory evoked potentials (SSEP), spinal magnetic resonance imaging (MRI) and urodynamics were assessed before and after treatment. Pain rating was performed using the McGill Pain Questionnaire and a visual analogue score scale. Bone marrow-derived mesenchymal stem cells were cultured and characterized by flow cytometry, cell differentiation assays and G-band karyotyping. Mesenchymal stem cells were injected directly into the lesion following laminectomy and durotomy. Results Cell transplantation was an overall safe and well-tolerated procedure. All subjects displayed variable improvements in tactile sensitivity and eight subjects developed lower limbs motor functional gains, principally in the hip flexors. Seven subjects presented sacral sparing and improved American Spinal Injury Association impairment scale (AIS) grades to B or C – incomplete injury. Nine subjects had improvements in urologic function. One subject presented changes in SSEP 3 and 6 months after mesenchymal stem cells transplantation. Statistically significant correlations between the improvements in neurological function and both injury size and level were found. Conclusion Intralesional transplantation of autologous mesenchymal stem cells in subjects with chronic, complete spinal cord injury is safe, feasible, and may promote neurological improvements. Trial registration ClinicalTrials.gov NCT01325103 – Registered 28 March 2011
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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ISSN:1757-6512
1757-6512
DOI:10.1186/scrt516