Safety and Efficacy of Stem Cell Therapy in Patients With Autism
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|ClinicalTrials.gov Identifier: NCT01343511|
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : October 14, 2011
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Childhood Autism Rating Scale，CARS [ Time Frame: 6 months after treatment ]
- Clinical Global Impression Scale，CGI [ Time Frame: 6 months after treatment ]
- Aberrant Behavior Checklist，ABC [ Time Frame: 6 months after treatment ]
- Adverse Event and Serious Adverse Event [ Time Frame: 6 months after treatment ]
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|Ages Eligible for Study:||3 Years to 12 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
- 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.
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
|Shandong Jiaotong Hospital|
|Jinan, Shandong, China, 250031|
|Principal Investigator:||Yongtao Lv||Shandong Jiaotong Hospital|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Shenzhen Beike Bio-Technology Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||April 28, 2011 Key Record Dates|
|Last Update Posted:||October 14, 2011|
|Last Verified:||October 2011|
human cord blood mononuclear cells
human umbilical cord mesenchymal stem cells
Autism Spectrum Disorder
Child Development Disorders, Pervasive