Back to resultsSafety and Efficacy of Stem Cell Therapy in Patients With Autism
Primary Purpose
Autism
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
human cord blood mononuclear cells
human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autism, human cord blood mononuclear cells, human umbilical cord mesenchymal stem cells
Eligibility 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.
Sites / Locations
- Shandong Jiaotong Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Rehabilitation plus hCB-MNCs treatment
Rehabilitation plus hCB-MNCs and hUC-MSCs therapy
Arm Description
Participants will be given rehabilitation therapy plus human cord blood mononuclear cells transplantation with a 6 months follow-up.
Participants will be given rehabilitation therapy plus combination of hCB-MNCs together with hUC-MSCs transplantation with a 6 months follow-up.
Outcomes
Primary Outcome Measures
Childhood Autism Rating Scale，CARS
Clinical Global Impression Scale，CGI
Secondary Outcome Measures
Aberrant Behavior Checklist，ABC
Adverse Event and Serious Adverse Event
Full Information
NCT ID
NCT01343511
First Posted
April 26, 2011
Last Updated
October 13, 2011
Sponsor
Shenzhen Beike Bio-Technology Co., Ltd.
Collaborators
Shandong Jiaotong Hospital, Association for the Handicapped Of Jinan
1. Study Identification
Unique Protocol Identification Number
NCT01343511
Brief Title
Safety and Efficacy of Stem Cell Therapy in Patients With Autism
Official Title
Phase Ι/Π Study of Stem Cell Therapy in Patients With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Beike Bio-Technology Co., Ltd.
Collaborators
Shandong Jiaotong Hospital, Association for the Handicapped Of Jinan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Autism, human cord blood mononuclear cells, human umbilical cord mesenchymal stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation plus hCB-MNCs treatment
Arm Type
Experimental
Arm Description
Participants will be given rehabilitation therapy plus human cord blood mononuclear cells transplantation with a 6 months follow-up.
Arm Title
Rehabilitation plus hCB-MNCs and hUC-MSCs therapy
Arm Type
Experimental
Arm Description
Participants will be given rehabilitation therapy plus combination of hCB-MNCs together with hUC-MSCs transplantation with a 6 months follow-up.
Intervention Type
Biological
Intervention Name(s)
human cord blood mononuclear cells
Other Intervention Name(s)
Group 1
Intervention Description
Participants will be given rehabilitation therapy plus hCB-MNCs transplantation.
Intervention Type
Biological
Intervention Name(s)
human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Other Intervention Name(s)
Group 2
Intervention Description
Participants will be given rehabilitation therapy plus and hCB-MNCs and hUC-MSCs transplantation.
Primary Outcome Measure Information:
Title
Childhood Autism Rating Scale，CARS
Time Frame
6 months after treatment
Title
Clinical Global Impression Scale，CGI
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
Aberrant Behavior Checklist，ABC
Time Frame
6 months after treatment
Title
Adverse Event and Serious Adverse Event
Time Frame
6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongtao Lv
Organizational Affiliation
Shandong Jiaotong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong Jiaotong Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250031
Country
China
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
PubMed Identifier
23978163
Citation
Lv YT, Zhang Y, Liu M, Qiuwaxi JN, Ashwood P, Cho SC, Huan Y, Ge RC, Chen XW, Wang ZJ, Kim BJ, Hu X. Transplantation of human cord blood mononuclear cells and umbilical cord-derived mesenchymal stem cells in autism. J Transl Med. 2013 Aug 27;11:196. doi: 10.1186/1479-5876-11-196.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of Stem Cell Therapy in Patients With Autism
We'll reach out to this number within 24 hrs