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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.

Tracking Information
First Submitted Date  ICMJE April 26, 2011
First Posted Date  ICMJE April 28, 2011
Last Update Posted Date October 14, 2011
Study Start Date  ICMJE March 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
  • Childhood Autism Rating Scale，CARS [ Time Frame: 6 months after treatment ]
  • Clinical Global Impression Scale，CGI [ Time Frame: 6 months after treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
  • Aberrant Behavior Checklist，ABC [ Time Frame: 6 months after treatment ]
  • Adverse Event and Serious Adverse Event [ Time Frame: 6 months after treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Stem Cell Therapy in Patients With Autism
Official Title  ICMJE Phase Ι/Π Study of Stem Cell Therapy in Patients With Autism
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE
  • Biological: human cord blood mononuclear cells
    Participants will be given rehabilitation therapy plus hCB-MNCs transplantation.
    Other Name: Group 1
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Biological: human cord blood mononuclear cells
  • 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.
    Intervention: Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2011)		 37
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01343511
Other Study ID Numbers  ICMJE BKCR-AUTISM-1.0(2009)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Shenzhen Beike Bio-Technology Co., Ltd.
Original Responsible Party Yongtao Lv / Professor, Shandong Traffic Hospital
Current Study Sponsor  ICMJE Shenzhen Beike Bio-Technology Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Shandong Jiaotong Hospital
  • Association for the Handicapped Of Jinan
Investigators  ICMJE
Principal Investigator: Yongtao Lv Shandong Jiaotong Hospital
PRS Account Shenzhen Beike Bio-Technology Co., Ltd.
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP