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The problem
Intervention: Multiple intravenous infusions of allogeneic umbilical cord blood mononuclear cells (3 × 10⁸ cells per infusion, four infusions at weekly intervals)
Who it was tested with: 34 children aged 3 to 8 years diagnosed with autism spectrum disorder and peripheral immune dysregulation.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"a single-center, double-blind, randomized, placebo-controlled trial (RCT), 34 children (aged 3 to 8 years) diagnosed with ASD were randomly assigned to receive intravenous infusion of allogeneic UCB-MNCs (3 × 10⁸ cells per infusion) (n = 17) or placebo (n = 17) four times with 1-week interval... followed up for 13 weeks." This is a rigorous experimental design with randomization and blinding, meeting the criteria for the highest evidence tier.
Single-center trial with small sample size (n=34); modest effect sizes; unclear clinical significance of improvements; results specific to children with both ASD and documented immune dysregulation; longer-term follow-up data not provided.
Across countries and designs
1 study · 1 country
