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

This study is currently recruiting participants. (see Contacts and Locations)

Verified June 2015 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: June 3, 2015

Last verified: June 2015

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 Spectrum Disorder

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 Study Completion Date:	December 2016
Estimated Primary Completion Date:	November 2016 (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 (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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
Study First Received:	November 22, 2012
Last Updated:	June 3, 2015
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 Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016

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