https://journals.sagepub.com/doi/pdf/10.3727/096368915X689622

Clinical Trials with Mesenchymal Stem Cells: An Update:

https://www.cell.com/cell-stem-cell/pdf/S1934-5909(15)00267-2.pdf

Stem Cell Therapies in Clinical Trials: Progress and Challenges

Background: The evidence base for the diagnosis and management of amyotrophic lateral sclerosis (ALS) is weak. Objectives: To provide evidence-based or expert recommendations for the diagnosis and ...

/pdf/efns-guidelines-on-the-clinical-management-of-amyotrophic-23ryvnse4m.pdf

EFNS guidelines on the Clinical Management of Amyotrophic Lateral Sclerosis (MALS) : revised report of an EFNS task force

Objective To evaluate the feasibility, safety, and immunological effects of intrathecal and intravenous administration of autologous mesenchymal stem cells (MSCs) (also called mesenchymal stromal cells ) in patients with multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). Design A phase 1/2 open-safety clinical trial. Patients Fifteen patients with MS (mean [SD] Expanded Disability Status Scale [EDSS] score, 6.7 [1.0]) and 19 with ALS (mean [SD] Amyotrophic Lateral Sclerosis Functional Rating Scale [ALSFRS] score, 20.8 [8.0]) were enrolled. Intervention After culture, a mean (SD) of 63.2 × 10 6 (2.5 × 10 6 ) MSCs was injected intrathecally (n = 34) and intravenously (n = 14). In 9 cases, MSCs were magnetically labeled with the superparamagnetic iron oxide ferumoxides (Feridex). Main Outcome Measures The main outcome measure was the recording of side effects. Follow-up (≤25 months) included adverse events evaluation, neurological disability assessment by means of the EDSS, magnetic resonance imaging to exclude unexpected pathologies and track the labeled stem cells, and immunological tests to assess the short-term immunomodulatory effects of MSC transplantation. Results Twenty-one patients had injection-related adverse effects consisting of transient fever, and 15 reported headache. No major adverse effects were reported during follow-up. The mean ALSFRS score remained stable during the first 6 months of observation, whereas the mean (SD) EDSS score improved from 6.7 (1.0) to 5.9 (1.6). Magnetic resonance imaging visualized the MSCs in the occipital horns of the ventricles, indicating the possible migration of ferumoxides-labeled cells in the meninges, subarachnoid space, and spinal cord. Immunological analysis revealed an increase in the proportion of CD4 + CD25 + regulatory T cells, a decrease in the proliferative responses of lymphocytes, and the expression of CD40 + , CD83 + , CD86 + , and HLA-DR on myeloid dendritic cells at 24 hours after MSC transplantation. Conclusion Transplantation of MSCs in patients with MS and ALS is a clinically feasible and relatively safe procedure and induces immediate immunomodulatory effects. Trial Registration clinicaltrials.gov Identifier:NCT00781872

/pdf/safety-and-immunological-effects-of-mesenchymal-stem-cell-gx1qd2zygp.pdf

Safety and immunological effects of mesenchymal stem cell transplantation in patients with multiple sclerosis and amyotrophic lateral sclerosis.

Key Science Research Project of Fujian Province, China [2009Y4001]; Key Laboratory of Fujian Province, China [2008J1006]

https://jamanetwork.com/journals/jama/articlepdf/1105090/joc25022_1169_1177.pdf

Induction therapy with autologous mesenchymal stem cells in living-related kidney transplants: a randomized controlled trial.

https://www.fondazionevialliemauro.org/wp-content/uploads/2014/01/Aggiornamento-Experimental-Neurology.pdf

R. Vercelli

Papers

Mesenchymal stem cell transplantation in amyotrophic lateral sclerosis: A Phase I clinical trial