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

Sponsor:

Information provided by (Responsible Party):

M.D Laura Villarreal Martinez, Hospital Universitario Dr. Jose E. Gonzalez

Study Description

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


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

Genetics Home Reference related topics: Autism spectrum disorder

MedlinePlus related topics: Autism Spectrum Disorder

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

IDEA Improvement [ Time Frame: 6 months ]
Improvement in IDEA evaluation

Secondary Outcome Measures :

CARS improvement [ Time Frame: 6 months ]
Improvement in CARS evaluation

Eligibility Criteria

Information from the National Library of Medicine

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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

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


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:

Siniscalco D, Sapone A, Cirillo A, Giordano C, Maione S, Antonucci N. Autism spectrum disorders: is mesenchymal stem cell personalized therapy the future? J Biomed Biotechnol. 2012;2012:480289. doi: 10.1155/2012/480289. Epub 2012 Feb 13. Review.

Ichim TE, Solano F, Glenn E, Morales F, Smith L, Zabrecky G, Riordan NH. Stem cell therapy for autism. J Transl Med. 2007 Jun 27;5:30. Review.

Mehta T, Feroz A, Thakkar U, Vanikar A, Shah V, Trivedi H. Subarachnoid placement of stem cells in neurological disorders. Transplant Proc. 2008 May;40(4):1145-7. doi: 10.1016/j.transproceed.2008.03.026.

Hayashi T, Iwai M, Ikeda T, Jin G, Deguchi K, Nagotani S, Zhang H, Sehara Y, Nagano I, Shoji M, Ikenoue T, Abe K. Neural precursor cells division and migration in neonatal rat brain after ischemic/hypoxic injury. Brain Res. 2005 Mar 15;1038(1):41-9.

Nakatomi H, Kuriu T, Okabe S, Yamamoto S, Hatano O, Kawahara N, Tamura A, Kirino T, Nakafuku M. Regeneration of hippocampal pyramidal neurons after ischemic brain injury by recruitment of endogenous neural progenitors. Cell. 2002 Aug 23;110(4):429-41.

Goldman SA, Schanz S, Windrem MS. Stem cell-based strategies for treating pediatric disorders of myelin. Hum Mol Genet. 2008 Apr 15;17(R1):R76-83. doi: 10.1093/hmg/ddn052. Review.

Rempe DA, Kent TA. Using bone marrow stromal cells for treatment of stroke. Neurology. 2002 Aug 27;59(4):486-7.

Felling RJ, Snyder MJ, Romanko MJ, Rothstein RP, Ziegler AN, Yang Z, Givogri MI, Bongarzone ER, Levison SW. Neural stem/progenitor cells participate in the regenerative response to perinatal hypoxia/ischemia. J Neurosci. 2006 Apr 19;26(16):4359-69.

Gordon PH, Yu Q, Qualls C, Winfield H, Dillon S, Greene PE, Fahn S, Breeze RE, Freed CR, Pullman SL. Reaction time and movement time after embryonic cell implantation in Parkinson disease. Arch Neurol. 2004 Jun;61(6):858-61.

Kulbatski I, Mothe AJ, Nomura H, Tator CH. Endogenous and exogenous CNS derived stem/progenitor cell approaches for neurotrauma. Curr Drug Targets. 2005 Feb;6(1):111-26. Review.


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 ( 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:


Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders

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