Clinical trial NCT01740869: Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders
Official title: Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Autism
Autism Spectrum
Keywords: autism
autism spectrum
stem cells
children
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: IDEA Improvement
timeFrame: 6 months
Secondary outcomes:
measure: CARS improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez
state: Nuevo Leon
Study officials:
References:
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