Trial reportStem cell research & therapy2025
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.
Trial report in Stem cell research & therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Educational Intervention for Autism Spectrum Disorders (ASD): A Phase 2 Randomised Controlled Trial
Autism Spectral Disorder (ASD) In Adolescent-Adults Treated by Multimodal Protocol: IV Autologous cSVF, Interval IV Autologous MSCs (Cryopreserved), Strick Ketogenic Diet RESET Program, and Fecal Microbiota Transplantation (FMT)
Who cites it
2 citing papers in PubMed.
- Efficacy and safety of allogeneic umbilical cord blood mononuclear cells therapy in children with autism spectrum disorder and immune dysregulation: a single-center, double-blinded, randomized, placebo-controlled trial.Stem cell research & therapy · 2026Trial
- Intrathecal injection of bone marrow concentrate in children with autism spectrum disorder: a retrospective chart analysis.Frontiers in medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
backgroundThis 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).
methodsFifty-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 Rating Scale (CARS), and the Clinical Global Impression-Severity (CGI-S) scale scores and (2) improvements in social interaction, adaptive behavior, and daily living skills measured by the Vineland Adaptive Behavior Scales (VABS-II) and Clinical Global Impression-Improvement (CGI-I) scale scores.
resultsAt 12 months, the CT group presented a 48.0% reduction in individuals classified at the most severe DSM-5 level compared with 8.0% in the control group (p = 0.004). The CARS scores were significantly lower in the CT group (-5.9 points) than in the control group (-1.5 points) (p < 0.0001). Similarly, the CT group exhibited greater improvement in CGI-S scores (-1.5 points) than did the control group (-0.1 points) (p < 0.0001). The VABS-II scores increased by 8.5 points in the CT group versus 1.4 points in the control group (p < 0.0001). Finally, the CGI-I scores improved from 2.8 to 2.0 in the CT group but worsened from 3.0 to 3.5 in the control group (p < 0.0001).
conclusionsIntrathecal BMMNC combined with an educational intervention improved disease severity and adaptability more than education alone in children with ASD.
trial registrationclinicaltrials.gov, NCT05307536. Date registered 12 February 2022. http://clinicaltrials.gov/study/NCT05307536 .
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.