Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders (Autism)
Primary Purpose
Autism, Autism Spectrum
Status
Unknown status
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring autism, autism spectrum, stem cells, children
Eligibility 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.
Sites / Locations
- Hematology Service, Hospital Universitario Dr. Jose E. GonzalezRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental: Patients
Control/Crossover
Arm Description
Children who will receive intrathecal autologous stem cells
We will evaluate with IDEA and CARS scales the control group for 6 months with the possibility to change arms after that time.
Outcomes
Primary Outcome Measures
IDEA Improvement
Improvement in IDEA evaluation
Secondary Outcome Measures
CARS improvement
Improvement in CARS evaluation
Full Information
NCT ID
NCT01740869
First Posted
November 22, 2012
Last Updated
June 3, 2015
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
1. Study Identification
Unique Protocol Identification Number
NCT01740869
Brief Title
Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders
Acronym
Autism
Official Title
Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum
Keywords
autism, autism spectrum, stem cells, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Patients
Arm Type
Experimental
Arm Description
Children who will receive intrathecal autologous stem cells
Arm Title
Control/Crossover
Arm Type
Other
Arm Description
We will evaluate with IDEA and CARS scales the control group for 6 months with the possibility to change arms after that time.
Intervention Type
Other
Intervention Name(s)
Stem cells
Other Intervention Name(s)
Bone marrow harvest and aspirate stem cells., Intrathecal stem cell aplication autologous stem cells into the spinal canal.
Primary Outcome Measure Information:
Title
IDEA Improvement
Description
Improvement in IDEA evaluation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
CARS improvement
Description
Improvement in CARS evaluation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Villarreal-Martinez, MD
Phone
+52 81 83 48 61 36
Ext
413
Email
dr_lauravillarreal@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Consuelo Mancias-Guerra, MD
Phone
+52 81 83 48 61 36
Ext
413
Email
consuelomanciasg@gmail.com
Facility Information:
Facility Name
Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Villarreal-Martinez, MD
Phone
+52 81 83 48 61 36
Ext
413
Email
dr_lauravillarreal@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
22496609
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.
Results Reference
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PubMed Identifier
17597540
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. doi: 10.1186/1479-5876-5-30.
Results Reference
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PubMed Identifier
18555135
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.
Results Reference
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PubMed Identifier
15748871
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. doi: 10.1016/j.brainres.2004.12.048.
Results Reference
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PubMed Identifier
12202033
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. doi: 10.1016/s0092-8674(02)00862-0.
Results Reference
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PubMed Identifier
18632701
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.
Results Reference
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PubMed Identifier
12196638
Citation
Rempe DA, Kent TA. Using bone marrow stromal cells for treatment of stroke. Neurology. 2002 Aug 27;59(4):486-7. doi: 10.1212/wnl.59.4.486. No abstract available.
Results Reference
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PubMed Identifier
16624956
Citation
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. doi: 10.1523/JNEUROSCI.1898-05.2006.
Results Reference
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PubMed Identifier
15210522
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. doi: 10.1001/archneur.61.6.858.
Results Reference
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PubMed Identifier
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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. doi: 10.2174/1389450053345037.
Results Reference
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Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders
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