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Trial record 7 of 9 for:    beike

Safety and Efficacy of Stem Cell Therapy in Patients With Autism

This study has been completed.
Sponsor:
Collaborators:
Shandong Jiaotong Hospital
Association for the Handicapped Of Jinan
Information provided by (Responsible Party):
Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01343511
First received: April 26, 2011
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention 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
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ι/Π Study of Stem Cell Therapy in Patients With Autism

Resource links provided by NLM:


Further study details as provided by Shenzhen Beike Bio-Technology Co., Ltd.:

Primary Outcome Measures:
  • Childhood Autism Rating Scale,CARS [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale,CGI [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aberrant Behavior Checklist,ABC [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
  • Adverse Event and Serious Adverse Event [ Time Frame: 6 months after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343511

Locations
China, Shandong
Shandong Jiaotong Hospital
Jinan, Shandong, China, 250031
Sponsors and Collaborators
Shenzhen Beike Bio-Technology Co., Ltd.
Shandong Jiaotong Hospital
Association for the Handicapped Of Jinan
Investigators
Principal Investigator: Yongtao Lv Shandong Jiaotong Hospital
  More Information

No publications provided by Shenzhen Beike Bio-Technology Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01343511     History of Changes
Other Study ID Numbers: BKCR-AUTISM-1.0(2009)
Study First Received: April 26, 2011
Last Updated: October 13, 2011
Health Authority: China: Ministry of Health

Keywords provided by Shenzhen Beike Bio-Technology Co., Ltd.:
Autism
human cord blood mononuclear cells
human umbilical cord mesenchymal stem cells

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on November 20, 2014