Abstract
Over the past two decades, significant advances have been made in the field of regenerative medicine. However, despite being of the utmost clinical urgency, there remains a paucity of therapeutic strategies for conditions with substantial neurodegeneration such as (progressive) multiple sclerosis (MS), spinal cord injury (SCI), Parkinson’s disease (PD) and Alzheimer’s disease (AD). Different cell types, such as mesenchymal stromal cells (MSC), neuronal stem cells (NSC), olfactory ensheathing cells (OEC), neurons and a variety of others, already demonstrated safety and regenerative or neuroprotective properties in the central nervous system during the preclinical phase. As a result of these promising findings, in recent years, these necessary types of cell therapies have been intensively tested in clinical trials to establish whether these results could be confirmed in patients. However, extensive research is still needed regarding elucidating the exact mechanism of action, possible immune rejection, functionality and survival of the administered cells, dose, frequency and administration route. To summarize the current state of knowledge, we conducted a systematic review with meta-analysis. A total of 27,043 records were reviewed by two independent assessors and 71 records were included in the final quantitative analysis. These results show that the overall frequency of serious adverse events was low: 0.03 (95% CI: 0.01–0.08). In addition, several trials in MS and SCI reported efficacy data, demonstrating some promising results on clinical outcomes. All randomized controlled studies were at a low risk of bias due to appropriate blinding of the treatment, including assessors and patients. In conclusion, cell-based therapies in neurodegenerative disease are safe and feasible while showing promising clinical improvements. Nevertheless, given their high heterogeneity, the results require a cautious approach. We advocate for the harmonization of study protocols of trials investigating cell-based therapies in neurodegenerative diseases, adverse event reporting and investigation of clinical outcomes.
Highlights
Over the past two decades, significant advances have been made in the field of regenerative medicine, which focuses on developing methods to restore, regrow or replace damaged or dysfunctional cells, tissues and organs [1]
The search terms used for the search on clinicaltrails.gov were (Multiple sclerosis/Parkinson disease/Alzheimer disease /Spinal cord injury) AND (Regeneration/Remyelination/Biological therapy)
The results demonstrate that the frequency of serious adverse event (SAE) after administration of a cell-based treatment was low (0.03)
Summary
Licensee MDPI, Basel, Switzerland.Attribution (CC BY) license (https://creativecommons.org/licenses/by/ 4.0/).Over the past two decades, significant advances have been made in the field of regenerative medicine, which focuses on developing methods to restore, regrow or replace damaged or dysfunctional cells, tissues and organs [1]. In 2009, Chondroselect (TiGenixN.V.) was the first regenerative cellular therapy that entered the European market, using autologous ex vivo expanded chondrocytes. Ever since, dozens of regenerative treatments have been successfully launched on the market targeting, amongst other things, cartilage defects, burn wounds, osteoarthritis, Crohn’s disease and ischemia [1]. Despite promising
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