Transplantation of autologous mesenchymal stromal cells in complete cervical spinal cord injury: a pilot study

Carolina Thé Macêdo; Bruno Solano de Freitas Souza; Cristiane Flora Villarreal; Daniela Nascimento Silva; Kátia Nunes da Silva; Clarissa Lima E Moura de Souza; Daniela da Silva Paixão; Milena da Rocha Bezerra; Antônio Olímpio da Silva Moura Costa; Eduardo Santos Brazão; Josildo Pereira Marins Filho; André Costa Matos; Ricardo Ribeiro Dos Santos; Milena Botelho Pereira Soares

doi:10.3389/fmed.2024.1451297

Transplantation of autologous mesenchymal stromal cells in complete cervical spinal cord injury: a pilot study

Front Med (Lausanne). 2024 Sep 12:11:1451297. doi: 10.3389/fmed.2024.1451297. eCollection 2024.

Authors

Carolina Thé Macêdo^{1

2

3}, Bruno Solano de Freitas Souza^{1

2

4}, Cristiane Flora Villarreal^{1

5}, Daniela Nascimento Silva^{1

3}, Kátia Nunes da Silva^{1

4}, Clarissa Lima E Moura de Souza^{1

2}, Daniela da Silva Paixão¹, Milena da Rocha Bezerra¹, Antônio Olímpio da Silva Moura Costa², Eduardo Santos Brazão², Josildo Pereira Marins Filho², André Costa Matos², Ricardo Ribeiro Dos Santos^{1

3

6}, Milena Botelho Pereira Soares^{1

3

6}

Affiliations

¹ Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ), Salvador, Bahia, Brazil.
² Hospital São Rafael, Salvador, Bahia, Brazil.
³ SENAI Institute for Innovation in Advanced Health Systems, SENAI CIMATEC, Salvador, Bahia, Brazil.
⁴ Center for Biotechnology and Cell Therapy, Hospital São Rafael, Salvador, Bahia, Brazil.
⁵ Faculty of Pharmacy, Federal University of Bahia, Salvador, Bahia, Brazil.
⁶ National Institute of Science and Technology for Regenerative Medicine, Rio de Janeiro, Rio de Janeiro, Brazil.

Abstract

Objective: Spinal cord injury (SCI) is a serious condition that can lead to partial or complete paraplegia or tetraplegia. Currently, there are few therapeutic options for these conditions, which are mainly directed toward the acute phase, such as surgical intervention and high-dose steroid administration. Mesenchymal stromal cells (MSC) have been shown to improve neurological function following spinal cord injury. The aim of the study was to evaluate the safety, feasibility, and potential efficacy of MSC transplantation in patients with cervical traumatic SCI.

Methods: We included seven subjects with chronic traumatic SCI (> 1 year) at the cervical level, classified as American Spinal Cord Injury Association impairment scale (AIS) grade A. Subjects received two doses of autologous bone marrow derived MSC, the first by direct injection into the lesion site after hemilaminectomy and the second three months later by intrathecal injection. Neurologic evaluation, spinal magnetic resonance imaging (MRI), urodynamics, and life quality questionnaires were assessed before and after treatment.

Results: Cell transplantation was safe without severe or moderate adverse effects, and the procedures were well tolerated. Neurological evaluation revealed discrete improvements in sensitivity below the lesion level, following treatment. Five subjects showed some degree of bilateral sensory improvement for both superficial and deep mechanical stimuli compared to the pretreatment profile. No significant alterations in bladder function were observed during this study.

Conclusion: Transplantation of autologous MSC in patients with chronic cervical SCI is a safe and feasible procedure. Further studies are required to confirm the efficacy of this therapeutic approach.

Clinical trial registration: https://clinicaltrials.gov/study/NCT02574572, identifier NCT02574572.

Keywords: cellular therapy; mesenchymal stromal cells (MSC); spinal cord injury; stem cell; tetraplegia.

Associated data

ClinicalTrials.gov/NCT02574572

Grants and funding

The authors declare that financial support was received for the research, authorship, and/or publication of this article. This work was financially supported by Brazilian Development Bank (BNDES) grant number 12.2.1448.1.