Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Autism Spectrum; Autism

Treatments: Other: Stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01740869

Autism uanl (Other Identifier)

HE12-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental: Patients

Experimental group

Description:

Children who will receive intrathecal autologous stem cells

Treatment:

Other: Stem cells

Control/Crossover

Other group

Description:

We will evaluate with IDEA and CARS scales the control group for 6 months with the possibility to change arms after that time.

Treatment:

Other: Stem cells