Outcomes of autologous bone marrow mononuclear cell administration combined with educational intervention in the treatment of autism spectrum disorder: a randomized, open-label, controlled phase II clinical trial.

ABSTRACT:

Background

This study evaluated the effectiveness of intrathecal autologous bone marrow mononuclear cell (BMMNC) therapy combined with education compared with education alone for the treatment of autism spectrum disorder (ASD).

Methods

Fifty-four children with ASD, aged three to seven years, were randomly assigned to two groups. Fifty patients completed the study (25 patients per group). The cell therapy (CT) group received two BMMNC infusions six months apart along with an educational intervention, while the control group received education only. Efficacy outcomes were assessed at baseline, two, six, and 12 months, based on: (1) changes in ASD severity evaluated through the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the Childhood Autism Ra

SUBMITTER: Nguyen LT 

PROVIDER: S-EPMC12123819 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature