Safety and Efficacy of Stem Cell Therapy in Patients With Autism

October 13, 2011 updated by: Shenzhen Beike Bio-Technology Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250031
        • Shandong jiaotong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Childhood Autism Rating Scale，CARS
Time Frame: 6 months after treatment
6 months after treatment
Clinical Global Impression Scale，CGI
Time Frame: 6 months after treatment
6 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Aberrant Behavior Checklist，ABC
Time Frame: 6 months after treatment
6 months after treatment
Adverse Event and Serious Adverse Event
Time Frame: 6 months after treatment
6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Beike Bio-Technology Co., Ltd.

Collaborators

Shandong Jiaotong Hospital
Association for the Handicapped Of Jinan

Investigators

  • Principal Investigator: Yongtao Lv, Shandong jiaotong Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 26, 2011

First Submitted That Met QC Criteria

April 26, 2011

First Posted (Estimate)

April 28, 2011

Study Record Updates

Last Update Posted (Estimate)

October 14, 2011

Last Update Submitted That Met QC Criteria

October 13, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BKCR-AUTISM-1.0(2009)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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