Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders

Phase 1

• Conditions: Autism; Autism Spectrum
• Interventions: Other: Stem cells

• 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
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental: Patients	Stem cells	Children who will receive intrathecal autologous stem cells
Control/Crossover	Stem cells	We will evaluate with IDEA and CARS scales the control group for 6 months with the possibility to change arms after that time.

Primary Outcome Measures

Name	Time	Method
IDEA Improvement	6 months	Improvement in IDEA evaluation

Secondary Outcome Measures

Name	Time	Method
CARS improvement	6 months	Improvement in CARS evaluation

Trial Locations

Locations (1)

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