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Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders

This study is currently recruiting participants.
Verified April 2013 by Hospital Universitario Dr. Jose E. Gonzalez
Sponsor:
Information provided by (Responsible Party):
M.D Laura Villarreal Martinez, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01740869
First received: November 22, 2012
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Autism
Autism Spectrum
 Other: Stem cells
 Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • IDEA Improvement [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Improvement in IDEA evaluation


Secondary Outcome Measures:
  • CARS improvement [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Improvement in CARS evaluation


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01740869

Contacts
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
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

Publications:

Responsible Party: M.D Laura Villarreal Martinez, Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01740869     History of Changes
Other Study ID Numbers: HE12-021, Autism uanl
Study First Received: November 22, 2012
Last Updated: April 11, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
autism
autism spectrum
stem cells
children

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013