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Safety and Efficacy of Stem Cell Therapy in Patients With Autism

NCT ID: NCT01343511

Last Updated: 2011-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-05-31

Brief Summary

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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

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To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Autism.

Conditions

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Autism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rehabilitation plus hCB-MNCs treatment

Participants will be given rehabilitation therapy plus human cord blood mononuclear cells transplantation with a 6 months follow-up.

Group Type EXPERIMENTAL

human cord blood mononuclear cells

Intervention Type BIOLOGICAL

Participants will be given rehabilitation therapy plus hCB-MNCs transplantation.

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.

Group Type EXPERIMENTAL

human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

Participants will be given rehabilitation therapy plus and hCB-MNCs and hUC-MSCs transplantation.

Interventions

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human cord blood mononuclear cells

Participants will be given rehabilitation therapy plus hCB-MNCs transplantation.

Intervention Type 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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Group 1 Group 2

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Jiaotong Hospital

UNKNOWN

Sponsor Role collaborator

Association for the Handicapped Of Jinan

UNKNOWN

Sponsor Role collaborator

Shenzhen Beike Bio-Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yongtao Lv

Role: PRINCIPAL_INVESTIGATOR

Shandong Jiaotong Hospital

Locations

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Shandong Jiaotong Hospital

Jinan, Shandong, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT

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.

Reference Type DERIVED
PMID: 23978163 (View on PubMed)

Other Identifiers

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BKCR-AUTISM-1.0(2009)

Identifier Type: -

Identifier Source: org_study_id