Stem Cell Therapy in Autism Spectrum Disorders

NCT ID: NCT01974973

Last Updated: 2018-10-25

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with autism spectrum disorders

Detailed Description

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Conditions

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Autism Spectrum Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stem cell

autologous bone marrow mononuclear cell transplantation

Group Type EXPERIMENTAL

Autologous bone marrow mononuclear cell transplantation

Intervention Type PROCEDURE

Intrathecal autologous bone marrow mononuclear cell transplantation

Interventions

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Autologous bone marrow mononuclear cell transplantation

Intrathecal autologous bone marrow mononuclear cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed cases of any type of autism spectrum disorders
* age above 6 months

Exclusion Criteria

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia
Minimum Eligible Age

6 Months

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurogen Brain and Spine Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Neurogen brain and spine institute

Mumbai, Maharashtra, India

Site Status

Countries

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India

References

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Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93. doi: 10.3727/096368908787648074.

Reference Type BACKGROUND
PMID: 19364066 (View on PubMed)

Other Identifiers

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NGBSI-02

Identifier Type: -

Identifier Source: org_study_id

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