Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders (Autism)
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|ClinicalTrials.gov Identifier: NCT01740869|
Recruitment Status : Unknown
Verified June 2015 by M.D Laura Villarreal Martinez, Hospital Universitario Dr. Jose E. Gonzalez.
Recruitment status was: Recruiting
First Posted : December 4, 2012
Last Update Posted : June 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Autism Autism Spectrum||Other: Stem cells||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
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
- IDEA Improvement [ Time Frame: 6 months ]Improvement in IDEA evaluation
- CARS improvement [ Time Frame: 6 months ]Improvement in CARS evaluation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740869
|Contact: Laura Villarreal-Martinez, MD||+52 81 83 48 61 36 ext email@example.com|
|Contact: Consuelo Mancias-Guerra, MD||+52 81 83 48 61 36 ext firstname.lastname@example.org|
|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 email@example.com|