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Completed

NCT Number: NCT01740869

Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders

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.

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Key information

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Intrathecal Hematopoietic Stem Cells

Biological

Patients will be stimulated with granulocyte colony-stimulating factor (G-CSF) for 3 consecutive days. Bone marrow will be harvested, processed to isolate CD34+ hematopoietic stem cells and reduce red blood cells. An inoculum of 5-10 mL will then be infused intrathecally into the cerebrospinal fluid.

Observation with IDEA and CARS Scales

Other

Participants will be observed for 6 months without active intervention. They will be evaluated using the Childhood Autism Rating Scale (CARS) and the IDEA scale at baseline, 30 days, and 180 days. After 6 months, participants may crossover to the experimental arm.

Primary outcomes

  1. Change in Childhood Autism Rating Scale (CARS) score

    Time frame: 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 outcomes

  1. Change in IDEA scale score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Acronym: Autism

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Dec 4, 2012
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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