Safety and Efficacy of Stem Cell Therapy in Patients With Autism
Phase Ι/Π Study of Stem Cell Therapy in Patients With Autism
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 26, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedOctober 14, 2011
October 1, 2011
1.3 years
April 26, 2011
October 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Childhood Autism Rating Scale，CARS
6 months after treatment
Clinical Global Impression Scale，CGI
6 months after treatment
Secondary Outcomes (2)
Aberrant Behavior Checklist，ABC
6 months after treatment
Adverse Event and Serious Adverse Event
6 months after treatment
Study Arms (2)
Rehabilitation plus hCB-MNCs treatment
EXPERIMENTALParticipants will be given rehabilitation therapy plus human cord blood mononuclear cells transplantation with a 6 months follow-up.
Rehabilitation plus hCB-MNCs and hUC-MSCs therapy
EXPERIMENTALParticipants will be given rehabilitation therapy plus combination of hCB-MNCs together with hUC-MSCs transplantation with a 6 months follow-up.
Interventions
Participants will be given rehabilitation therapy plus hCB-MNCs transplantation.
Participants will be given rehabilitation therapy plus and hCB-MNCs and hUC-MSCs transplantation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shenzhen Beike Bio-Technology Co., Ltd.lead
- Shandong Jiaotong Hospitalcollaborator
- Association for the Handicapped Of Jinancollaborator
Study Sites (1)
Shandong Jiaotong Hospital
Jinan, Shandong, 250031, China
Related Publications (2)
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.
RESULTLv 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.
PMID: 23978163DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongtao Lv
Shandong Jiaotong Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2011
First Posted
April 28, 2011
Study Start
March 1, 2009
Primary Completion
June 1, 2010
Study Completion
May 1, 2011
Last Updated
October 14, 2011
Record last verified: 2011-10