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Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Autism Spectrum Disorder in Children: Safety Profile and Effect on Cytokine Levels.
Stem Cells Transl Med. 2019 10; 8(10):1008-1016.SC

Abstract

Individuals with autism spectrum disorder (ASD) suffer from developmental disabilities that impact communication, behavior, and social interaction. Immune dysregulation and inflammation have been linked to children with ASD, the latter manifesting in serum levels of macrophage-derived chemokine (MDC) and thymus, and activation-regulated chemokine (TARC). Mesenchymal stem cells derived from umbilical cord tissue (UC-MSCs) have immune-modulatory and anti-inflammatory properties, and have been safely used to treat a variety of conditions. This study investigated the safety and efficacy of UC-MSCs administered to children diagnosed with ASD. Efficacy was evaluated with the Autism Treatment Evaluation Checklist (ATEC) and the Childhood Autism Rating Scale (CARS), and with measurements of MDC and TARC serum levels. Twenty subjects received a dose of 36 million intravenous UC-MSCs every 12 weeks (four times over a 9-month period), and were followed up at 3 and 12 months after treatment completion. Adverse events related to treatment were mild or moderate and short in duration. The CARS and ATEC scores of eight subjects decreased over the course of treatment, placing them in a lower ASD symptom category when compared with baseline. MDC and TARC inflammatory cytokine levels also decreased for five of these eight subjects. The mean MDC, TARC, ATEC, and CARS values attained their lowest levels 3 months after the last administration. UC-MSC administration in children with ASD was therefore determined to be safe. Although some signals of efficacy were observed in a small group of children, possible links between inflammation levels and ASD symptoms should be further investigated. Stem Cells Translational Medicine 2019;8:1008-1016.

Authors+Show Affiliations

MediStem Panama, Inc., City of Knowledge, Clayton, Republic of Panama. Stem Cell Institute, Panama, Republic of Panama.Holistic Mind Steps, Panama, Republic of Panama.MediStem Panama, Inc., City of Knowledge, Clayton, Republic of Panama.Stem Cell Institute, Panama, Republic of Panama.MediStem Panama, Inc., City of Knowledge, Clayton, Republic of Panama.Stem Cell Institute, Panama, Republic of Panama.MediStem Panama, Inc., City of Knowledge, Clayton, Republic of Panama.Stem Cell Institute, Panama, Republic of Panama.Pacífica Salud, Hospital Punta Pacífica, Panama, Republic of Panama.

Pub Type(s)

Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31187597

Citation

Riordan, Neil H., et al. "Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Autism Spectrum Disorder in Children: Safety Profile and Effect On Cytokine Levels." Stem Cells Translational Medicine, vol. 8, no. 10, 2019, pp. 1008-1016.
Riordan NH, Hincapié ML, Morales I, et al. Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Autism Spectrum Disorder in Children: Safety Profile and Effect on Cytokine Levels. Stem Cells Transl Med. 2019;8(10):1008-1016.
Riordan, N. H., Hincapié, M. L., Morales, I., Fernández, G., Allen, N., Leu, C., Madrigal, M., Paz Rodríguez, J., & Novarro, N. (2019). Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Autism Spectrum Disorder in Children: Safety Profile and Effect on Cytokine Levels. Stem Cells Translational Medicine, 8(10), 1008-1016. https://doi.org/10.1002/sctm.19-0010
Riordan NH, et al. Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Autism Spectrum Disorder in Children: Safety Profile and Effect On Cytokine Levels. Stem Cells Transl Med. 2019;8(10):1008-1016. PubMed PMID: 31187597.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Autism Spectrum Disorder in Children: Safety Profile and Effect on Cytokine Levels. AU - Riordan,Neil H, AU - Hincapié,Maria Luisa, AU - Morales,Isabela, AU - Fernández,Giselle, AU - Allen,Nicole, AU - Leu,Cindy, AU - Madrigal,Marialaura, AU - Paz Rodríguez,Jorge, AU - Novarro,Nelson, Y1 - 2019/06/11/ PY - 2019/01/09/received PY - 2019/05/10/accepted PY - 2019/6/13/pubmed PY - 2020/6/27/medline PY - 2019/6/13/entrez KW - Autism KW - Cytokines KW - Mesenchymal stem cells KW - Safety KW - Umbilical cord mesenchymal stem cells SP - 1008 EP - 1016 JF - Stem cells translational medicine JO - Stem Cells Transl Med VL - 8 IS - 10 N2 - Individuals with autism spectrum disorder (ASD) suffer from developmental disabilities that impact communication, behavior, and social interaction. Immune dysregulation and inflammation have been linked to children with ASD, the latter manifesting in serum levels of macrophage-derived chemokine (MDC) and thymus, and activation-regulated chemokine (TARC). Mesenchymal stem cells derived from umbilical cord tissue (UC-MSCs) have immune-modulatory and anti-inflammatory properties, and have been safely used to treat a variety of conditions. This study investigated the safety and efficacy of UC-MSCs administered to children diagnosed with ASD. Efficacy was evaluated with the Autism Treatment Evaluation Checklist (ATEC) and the Childhood Autism Rating Scale (CARS), and with measurements of MDC and TARC serum levels. Twenty subjects received a dose of 36 million intravenous UC-MSCs every 12 weeks (four times over a 9-month period), and were followed up at 3 and 12 months after treatment completion. Adverse events related to treatment were mild or moderate and short in duration. The CARS and ATEC scores of eight subjects decreased over the course of treatment, placing them in a lower ASD symptom category when compared with baseline. MDC and TARC inflammatory cytokine levels also decreased for five of these eight subjects. The mean MDC, TARC, ATEC, and CARS values attained their lowest levels 3 months after the last administration. UC-MSC administration in children with ASD was therefore determined to be safe. Although some signals of efficacy were observed in a small group of children, possible links between inflammation levels and ASD symptoms should be further investigated. Stem Cells Translational Medicine 2019;8:1008-1016. SN - 2157-6580 UR - https://www.unboundmedicine.com/medline/citation/31187597/Allogeneic_Human_Umbilical_Cord_Mesenchymal_Stem_Cells_for_the_Treatment_of_Autism_Spectrum_Disorder_in_Children:_Safety_Profile_and_Effect_on_Cytokine_Levels_ L2 - https://doi.org/10.1002/sctm.19-0010 DB - PRIME DP - Unbound Medicine ER -