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Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders (Autism)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
M.D Laura Villarreal Martinez, Hospital Universitario Dr. Jose E. Gonzalez

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Autism Spectrum Other: Stem cells Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Patients
Children who will receive intrathecal autologous stem cells
 Other: Stem cells
Other Names:
  • Bone marrow harvest and aspirate stem cells.
  • Intrathecal stem cell aplication autologous stem cells into the spinal canal.
Control/Crossover
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
Other Names:
  • Bone marrow harvest and aspirate stem cells.
  • Intrathecal stem cell aplication autologous stem cells into the spinal canal.


Outcome Measures
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Primary Outcome Measures :
  1. IDEA Improvement [ Time Frame: 6 months ]
    Improvement in IDEA evaluation


Secondary Outcome Measures :
  1. CARS improvement [ Time Frame: 6 months ]
    Improvement in CARS evaluation


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Laura Villarreal-Martinez, MD +52 81 83 48 61 36 ext 413 dr_lauravillarreal@hotmail.com
Contact: Consuelo Mancias-Guerra, MD +52 81 83 48 61 36 ext 413 consuelomanciasg@gmail.com

Locations
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Mexico
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    dr_lauravillarreal@hotmail.com   
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
More Information
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Publications:

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Responsible Party: M.D Laura Villarreal Martinez, Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01740869    
Other Study ID Numbers: HE12-021
Autism uanl ( Other Identifier: Autism uanl )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by M.D Laura Villarreal Martinez, Hospital Universitario Dr. Jose E. Gonzalez:
autism
autism spectrum
stem cells
children
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders