Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders

Not Applicable

Completed

• Conditions: Autism; Autism Spectrum
• Interventions: Biological: Autologous Intrathecal Hematopoietic Stem Cells; Other: Observation with IDEA and CARS Scales

• Registration Number: NCT01740869
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary

The purpose of this study is to determine whether the plasticity of autologous intrathecal hematopoietic cells would improve the neurologic and the social skills of pediatric patients with autism spectrum disorders.

Detailed Description

There is accumulating evidence that shows that the administration of hematopoietic cells into the brain in the patients with spectrum autism could help in the physiopathology of the illness.

It has been found that after introducing hematopoietic cells in the subarachnoid space of the spinal cord, these cells may be transported through the cerebrospinal fluid and can be delivered more efficiently to the injured area, when compared to the intravenous route.

Patients will be stimulated for 3 consecutive days with granulocyte colony stimulating factor (G-CSF) and then their bone marrow will be harvested according to their weight. Bone marrow will be processed in order to obtain CD34+ cells and minimize the amount of red blood cells. An inoculum of 5 to 10mL of stem cells will be infused intrathecally. Patients will be evaluated with two scales "CARS" and the "IDEA" also we will check the clinical history. On days 0, 30 and 180.

Study Timeline

• Study Start: 2012-11-01
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Primary Completion: 2016-11
• Study Completion: 2017-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-09-10
• Last Update Posted: 2025-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Children aged 5 to 15 years, Diagnosis of Autism Spectrum Disorder (ASD) confirmed by DSM-5 criteria, Ability to comply with study procedures, including assessments with CARS and IDEA scales, Written informed consent obtained from parents or legal guardians.

Exclusion Criteria

Presence of severe neurological disorders other than ASD, History of immunodeficiency or hematologic disorders, Active infection at the time of enrollment, Previous treatment with intrathecal stem cells, Any medical condition that, in the investigator's judgment, would make participation unsafe.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Patients	Autologous Intrathecal Hematopoietic Stem Cells	Children with autism spectrum disorder who will receive intrathecal infusion of autologous CD34+ hematopoietic stem cells after G-CSF stimulation and bone marrow harvest.
Control	Observation with IDEA and CARS Scales	Children with autism spectrum disorder who will be observed for 6 months and evaluated with CARS and IDEA scales, with option to crossover to the experimental arm afterwards.

Primary Outcome Measures

Name	Time	Method
Change in Childhood Autism Rating Scale (CARS) score	Baseline, 30 days, and 180 days	CARS scale will be used to evaluate changes in autistic behavior and social interaction after treatment. Participants will be assessed at baseline, 30 days, and 180 days to measure improvement following the intrathecal infusion of autologous CD34+ hematopoietic stem cells.

Secondary Outcome Measures

Name	Time	Method
Change in IDEA scale score	Baseline, 30 days, and 180 days	IDEA scale will assess developmental and social abilities in participants. Measurements will be taken at baseline, 30 days, and 180 days to evaluate the effect of treatment on developmental progress.

Trial Locations

Locations (1)

Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez; 🇲🇽 Monterrey, Nuevo León, Mexico