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A single blind, placebo-controlled, single center, parallel group study to evaluate the efficacy and safety of cord blood mononuclear cell therapy in patients with autism (aged 2-7 years)

A single blind, placebo-controlled, single center, parallel group study to evaluate the efficacy and safety of cord blood mononuclear cell therapy in patients with autism (aged 2-7 years)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060331
Enrollment
Unknown
Registered
2022-05-28
Start date
2022-05-16
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autism spectrum disorder

Interventions

Experimental group:Umbilical cord blood mononuclear cells were intravenously transfused

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for autism in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV); 2. Childhood autism rating scale (CARS) >= 30 points; 3. Age 2 to 7 years old, weight 11-27 kg, gender is not limited; 4. No family history of bleeding and coagulation diseases; 5. Did not receive drug treatment that has a greater impact on the immune system, such as glucocorticoids, cytotoxic drugs, etc. before seeing a doctor; 6. No family history of cancer; 7. Agree to carry out post-rehabilitation treatment in the Second Hospital of Hebei Medical University.

Exclusion criteria

Exclusion criteria: 1. Have a history of severe allergic reactions in the past; 2. Any serious mental disorder or other autism spectrum disorder, such as Asperger's syndrome, Rett's syndrome or undefined pervasive developmental disorder; 3. Autism caused by active epilepsy, cerebrovascular disease or traumatic brain injury; 4. Severe heart, lung, liver, and kidney dysfunction: the test results of any of the following items of the subject are > 2 x ULN: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline Phosphatase (ALP), or total bilirubin > ULN (total bilirubin >= 1.5 x ULN if known to have Gilbert syndrome); 5. History of previous stem cell therapy; 6. Serious self-harm; 7. Have a history of syphilis, HIV and hepatitis infectious diseases; 8. Patients who cannot cooperate with follow-up visits.

Design outcomes

Primary

MeasureTime frame
Childhood Autism Rating Scale (CARS) score; Autism Behavior Checklist, ABC;Social Response Scale (SRS);Gesell developmental schedule, GDS;

Countries

China

Contacts

Public ContactXiuxia Wang

The Second Hospital of Hebei Medical University

wangxiuxia868@163.com+86 15803210573

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026