Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Autologous Bone Marrow Mononuclear Cell Administration in a Large Cohort Of 1011 Autism Spectrum Disorder Patients: A Clinical Study

Version 1 : Received: 21 July 2023 / Approved: 21 July 2023 / Online: 21 July 2023 (11:41:01 CEST)

How to cite: Sharma, A.; Gokulchandran, N.; Sane, H.; Kulkarni, P.; Kannan, K.; Shaikh, Z.; Biju, H.; Paranjape, A.; Dsa, M.; Badhe, P. Autologous Bone Marrow Mononuclear Cell Administration in a Large Cohort Of 1011 Autism Spectrum Disorder Patients: A Clinical Study. Preprints 2023, 2023071498. https://doi.org/10.20944/preprints202307.1498.v1 Sharma, A.; Gokulchandran, N.; Sane, H.; Kulkarni, P.; Kannan, K.; Shaikh, Z.; Biju, H.; Paranjape, A.; Dsa, M.; Badhe, P. Autologous Bone Marrow Mononuclear Cell Administration in a Large Cohort Of 1011 Autism Spectrum Disorder Patients: A Clinical Study. Preprints 2023, 2023071498. https://doi.org/10.20944/preprints202307.1498.v1

Abstract

Bone marrow mononuclear cells (BMMNCs) have emerged as a potential therapeutic strategy for various incurable conditions including autism spectrum disorder (ASD). To study its safety and efficacy, we analyzed 1011 patients who underwent intrathecal administration of autologous BMMNCs along with neurorehabilitation. At mean follow-up of 19.3 months after intervention, 90.6% patients showed overall improvement. Improvements were observed in attention concentration, command following, eye contact, sitting tolerance, social interaction, hyperactivity, communication, speech, aggressiveness, stereotypical and self-injurious behavior. Statistically significant changes were observed in scores of Indian Scale of Autism Assessment and Childhood Autism Rating Scale (p<0.05). On subgroup analysis, improvements were recorded irrespective of age and disease severity and better outcome was observed in patients who took multiple doses of cell therapy compared to single dose. Comparative Brain PET-CT scan of 401 patients showed improved brain metabolism after the intervention. No major adverse events were reported. Only 9 out of 1011 patients experienced seizures which were managed using medications. 4 out of 9 had history of seizures while 5 had normal EEG with no history. However, improvements were still observed in these 9 patients. Thus, intrathecal transplantation of autologous BMMNCs along with neurorehabilitation is safe and efficacious in patients with ASD.

Keywords

Autism Spectrum Disorder; Bone Marrow Mononuclear Cells; Autologous; Brain PET CT scan; Cell therapy; ISAA; CARS

Subject

Medicine and Pharmacology, Pediatrics, Perinatology and Child Health

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