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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders|
- IDEA Improvement [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Improvement in IDEA evaluation
- CARS improvement [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Improvement in CARS evaluation
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: Experimental: Patients
Children who will receive intrathecal autologous stem cells
Other: 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.
Other: Stem cells
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01740869
|Contact: Laura Villarreal-Martinez, MD||+52 81 83 48 61 36 ext firstname.lastname@example.org|
|Contact: Consuelo Mancias-Guerra, MD||+52 81 83 48 61 36 ext email@example.com|
|Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez||Recruiting|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Contact: Laura Villarreal-Martinez, MD +52 81 83 48 61 36 ext 413 firstname.lastname@example.org|