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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

Tracking Information
First Submitted Date  ICMJE November 22, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
IDEA Improvement [ Time Frame: 6 months ]
Improvement in IDEA evaluation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
CARS improvement [ Time Frame: 6 months ]
Improvement in CARS evaluation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders
Official Title  ICMJE Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism
  • Autism Spectrum
Intervention  ICMJE Other: Stem cells
Other Names:
  • Bone marrow harvest and aspirate stem cells.
  • Intrathecal stem cell aplication autologous stem cells into the spinal canal.
Study Arms  ICMJE
  • Experimental: Experimental: Patients
    Children who will receive intrathecal autologous stem cells
    Intervention: Other: Stem cells
  • 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.
    Intervention: Other: Stem cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740869
Other Study ID Numbers  ICMJE HE12-021
Autism uanl ( Other Identifier: Autism uanl )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D Laura Villarreal Martinez, Hospital Universitario Dr. Jose E. Gonzalez
Study Sponsor  ICMJE Hospital Universitario Dr. Jose E. Gonzalez
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Universitario Dr. Jose E. Gonzalez
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP