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Safety and Efficacy of Stem Cell Therapy in Patients With 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: NCT01343511
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : October 14, 2011
Sponsor:
Collaborators:
Shandong Jiaotong Hospital
Association for the Handicapped Of Jinan
Information provided by (Responsible Party):
Shenzhen Beike Bio-Technology Co., Ltd.

Study Description
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Brief Summary:
Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress .Neural hypoperfusion and immune deregulation are the two key pathologies associated with Autism. Human umbilical cord mesenchymal stem cells (hUC-MSCs) and human cord blood mononuclear cells (hCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. In this study, the safety and efficacy of hUC-MSCs and hCB-MNCs transplantation will be evaluated in patients with Autism.

Condition or disease Intervention/treatment Phase
Autism Biological: human cord blood mononuclear cells Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells Phase 1 Phase 2

Detailed Description:
To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Autism.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ι/Π Study of Stem Cell Therapy in Patients With Autism
Study Start Date : March 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : May 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: Rehabilitation plus hCB-MNCs treatment
Participants will be given rehabilitation therapy plus human cord blood mononuclear cells transplantation with a 6 months follow-up.
 Biological: human cord blood mononuclear cells
Participants will be given rehabilitation therapy plus hCB-MNCs transplantation.
Other Name: Group 1
Experimental: Rehabilitation plus hCB-MNCs and hUC-MSCs therapy
Participants will be given rehabilitation therapy plus combination of hCB-MNCs together with hUC-MSCs transplantation with a 6 months follow-up.
 Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Participants will be given rehabilitation therapy plus and hCB-MNCs and hUC-MSCs transplantation.
Other Name: Group 2


Outcome Measures
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Primary Outcome Measures :
  1. Childhood Autism Rating Scale，CARS [ Time Frame: 6 months after treatment ]
  2. Clinical Global Impression Scale，CGI [ Time Frame: 6 months after treatment ]

Secondary Outcome Measures :
  1. Aberrant Behavior Checklist，ABC [ Time Frame: 6 months after treatment ]
  2. Adverse Event and Serious Adverse Event [ Time Frame: 6 months after treatment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children between the ages of 3 and 12 years.
  • DSM-IV diagnosis of Autistic Disorder.
  • Total score of CARS ≥ 30.
  • Parents or legal guardian willing to sign the ICF.

Exclusion Criteria:

  • Any history of hypersensitivity to serum products, or other known drug and food allergy.
  • History of prior or current DSM-IV psychotic disorder (e.g., schizophrenia, bipolar disorder, other psychosis), Pervasive Developmental Disorder not otherwise specified (PDD NOS), Asperger's, or Rett's.
  • History of Epileptic seizure activity in the past 6 months.
  • Autism caused by seizure disorders (active), cerebrovascular disease or brain trauma.
  • The global autism ratings are assessed as being absent, minimal or mild.
  • Existing moderate or severe extrapyramidal symptoms (EPS) or history of tardive dyskinesia.
  • Subjects who have displayed significant self-injurious behavior (children who have caused visible harm to themselves).
  • HIV+
  • Acute and chronic hepatitis.
  • Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
  • Severe pulmonary and hematological disease, malignancy or hypo-immunity.
  • Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
  • Enrollment in other trials in the last 3 months.
  • Other criteria the investigator consider improper for inclusion.
Contacts and Locations
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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): NCT01343511


Locations
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China, Shandong
Shandong Jiaotong Hospital
Jinan, Shandong, China, 250031
Sponsors and Collaborators
Shenzhen Beike Bio-Technology Co., Ltd.
Shandong Jiaotong Hospital
Association for the Handicapped Of Jinan
Investigators
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Principal Investigator: Yongtao Lv Shandong Jiaotong Hospital
More Information
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Publications of Results:
Liu M, Sun LW, LV YT, Huan Y, Ge RC, Cao YL, Guo CQ, Chen XW. Stem cells for treatment of autism: Safety and efficacy. Zhongguo Zuzhi Gongcheng Yanjiu yu Linchuang Kangfu. 2010;14(32): 5967-5970.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01343511    
Other Study ID Numbers: BKCR-AUTISM-1.0(2009)
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: October 14, 2011
Last Verified: October 2011
Keywords provided by Shenzhen Beike Bio-Technology Co., Ltd.:
Autism
human cord blood mononuclear cells
human umbilical cord mesenchymal stem cells
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders