Stem Cell Therapy in Autism Spectrum Disorders | NCT01974973

Studies
Stem Cell Therapy in Autism Spectrum Disorders

NCT01974973

Sponsor

Neurogen Brain and Spine Institute

Status

Withdrawn

Last Update Posted

Oct 25, 2018Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Autism Spectrum Disorders

Interventions

Autologous bone marrow mononuclear cell transplantation

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jan 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Oct 28, 2013

First Submission Date that Met QC Criteria

Oct 28, 2013

First Posted Date

Nov 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2018

Last Update Posted Date

Oct 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stem cell	Experimental	autologous bone marrow mononuclear cell transplantation	Procedure: Autologous bone marrow mononuclear cell transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous bone marrow mononuclear cell transplantation	Procedure	Intrathecal autologous bone marrow mononuclear cell transplantation	Stem cell

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in the scales for Autism spectrum disorders		Six months

Secondary Outcomes

Measure	Description	Time Frame
Positron Emission Tomography- computed tomography to study change in brain metabolism		six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neurogen brain and spine institute		Mumbai	Maharashtra	400071	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19364066	Background	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.

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders