Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism

NCT ID: NCT03225651

Last Updated: 2019-09-06

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

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-18

Study Completion Date

2019-08-30

Brief Summary

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The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation for Autism children

Detailed Description

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The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation in the management of autism of 60 patients at Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam from January 2017 to December 2018

Conditions

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Stem Cell Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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Stem cell transplantation

Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward

Group Type EXPERIMENTAL

Stem cell transplantation

Intervention Type BIOLOGICAL

Transplantation of Autologous Bone Marrow Mononuclear cells

Psychological therapy and Rehabilitation

Intervention Type BEHAVIORAL

Psychological Therapy and Rehabilitation for autism children around 3 months

Psychological therapy and rehabilitation

Psychological therapy Rehabilitation in 3 months

Group Type EXPERIMENTAL

Stem cell transplantation

Intervention Type BIOLOGICAL

Transplantation of Autologous Bone Marrow Mononuclear cells

Psychological therapy and Rehabilitation

Intervention Type BEHAVIORAL

Psychological Therapy and Rehabilitation for autism children around 3 months

Interventions

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Stem cell transplantation

Transplantation of Autologous Bone Marrow Mononuclear cells

Intervention Type BIOLOGICAL

Psychological therapy and Rehabilitation

Psychological Therapy and Rehabilitation for autism children around 3 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-V diagnostic criteria for autistic disorder

Exclusion Criteria

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
* Severe psychiatric disorders
* Rett syndrome
* Fragile X syndrome
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vinmec Research Institute of Stem Cell and Gene Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, , Vietnam

Site Status

Countries

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Vietnam

References

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Than UTT, Nguyen LT, Nguyen PH, Nguyen XH, Trinh DP, Hoang DH, Nguyen PAT, Dang VD. Inflammatory mediators drive neuroinflammation in autism spectrum disorder and cerebral palsy. Sci Rep. 2023 Dec 18;13(1):22587. doi: 10.1038/s41598-023-49902-8.

Reference Type DERIVED
PMID: 38114596 (View on PubMed)

Nguyen Thanh L, Nguyen HP, Ngo MD, Bui VA, Dam PTM, Bui HTP, Ngo DV, Tran KT, Dang TTT, Duong BD, Nguyen PAT, Forsyth N, Heke M. Outcomes of bone marrow mononuclear cell transplantation combined with interventional education for autism spectrum disorder. Stem Cells Transl Med. 2021 Jan;10(1):14-26. doi: 10.1002/sctm.20-0102. Epub 2020 Sep 9.

Reference Type DERIVED
PMID: 32902182 (View on PubMed)

Other Identifiers

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VinmecRISCGT69

Identifier Type: -

Identifier Source: org_study_id

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