Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders

Autism Clinical Trial

— Autism  

Official title:

Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01740869
• Other study ID #: HE12-021
• Secondary ID: Autism uanl
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 22, 2012
• Last updated: June 3, 2015
• Start date: November 2012
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: Laura Villarreal-Martinez, MD
• Phone: +52 81 83 48 61 36
• Email: dr_lauravillarreal[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autism Spectrum
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• Stem cells

Locations

Country	Name	City	State
Mexico	Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IDEA Improvement	Improvement in IDEA evaluation	6 months	Yes
Secondary	CARS improvement	Improvement in CARS evaluation	6 months	Yes