Safety and Efficacy of Stem Cell Therapy in Patients With Autism

Autism Clinical Trial

Official title:

Phase Ι/Π Study of Stem Cell Therapy in Patients With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343511
• Other study ID #: BKCR-AUTISM-1.0(2009)
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 26, 2011
• Last updated: October 13, 2011
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2011
• Source: Shenzhen Beike Bio-Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Biological:
• human cord blood mononuclear cells
Participants will be given rehabilitation therapy plus hCB-MNCs transplantation.
• 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.

Locations

Country	Name	City	State
China	Shandong Jiaotong Hospital	Jinan	Shandong

Sponsors (3)

Lead Sponsor	Collaborator
Shenzhen Beike Bio-Technology Co., Ltd.	Association for the Handicapped Of Jinan, Shandong Jiaotong Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Childhood Autism Rating Scale,CARS		6 months after treatment	No
Primary	Clinical Global Impression Scale,CGI		6 months after treatment	No
Secondary	Aberrant Behavior Checklist,ABC		6 months after treatment	No
Secondary	Adverse Event and Serious Adverse Event		6 months after treatment	Yes