Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders

Conditions
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Autism, Autism Spectrum

Intervention / Treatment
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* Other: Stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with autism spectrum DSM4-TR Exclusion Criteria: Patients with neurodegenerative or autoimmune diseases. Patients with active infection in any organ or tissue at the time of entering the study, the onset of stimulation with G-CSF or at the procedure. Patients who do not sign the informed consent form.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Patients<br>Children who will receive intrathecal autologous stem cells | Other: Stem cells<br> <br> * Other names: Intrathecal stem cell aplication autologous stem cells into the spinal canal.;|
| Other: Control/Crossover<br>We will evaluate with IDEA and CARS scales the control group for 6 months with the possibility to change arms after that time. | Other: Stem cells<br> <br> * Other names: Intrathecal stem cell aplication autologous stem cells into the spinal canal.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IDEA Improvement | Improvement in IDEA evaluation | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CARS improvement | Improvement in CARS evaluation | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autism, autism spectrum, stem cells, children