Treatment of Autism in Children Ages 4 to 14 Using Allogeneic Wharton Jelly Mesenchymal Stromal Cells WJMSC with Intravenous Doses

What this Trial Is About

Autism spectrum disorders ASDs are complex neuro-developmental conditions characterized by ongoing difficulties in social communication and interaction, along with restricted and repetitive behaviors or interests. These disorders involve inflammatory conditions and immune system dysfunction, which has led researchers to explore cell-based therapies as a potential treatment. This study is a Phase 1 clinical trial focusing on evaluating the safety and effects of stem cells for children with ASD. Participants in the trial receive three intravenous doses of allogeneic Wharton Jelly Mesenchymal Stromal Cells WJMSC at a dose of 1 million cells per kilogram of body weight. These doses are administered every two weeks as the treatment approach. The study aims to assess both safety and efficacy over a follow-up period extending to 12 months after treatment. During the study, researchers monitor participants through laboratory tests to evaluate the safety profile of the treatment. They also measure changes in attention and hyperactivity symptoms using the Adult ADHD Self-Report Scale over a 12-month follow-up. The trial involves children aged 4 to 14 years diagnosed with ASD, with regular assessments and follow-up visits scheduled throughout the year to observe treatment effects and ensure participant safety.

Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism