NCT01974973

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

6.4 years

First QC Date

October 28, 2013

Last Update Submit

October 23, 2018

Conditions

Autism Spectrum Disorders

Keywords

autism spectrum disordersstem cells

Outcome Measures

Primary Outcomes (1)

  • Improvement in the scales for Autism spectrum disorders

    Six months

Secondary Outcomes (1)

  • Positron Emission Tomography- computed tomography to study change in brain metabolism

    six months

Study Arms (1)

Stem cell

EXPERIMENTAL

autologous bone marrow mononuclear cell transplantation

Procedure: Autologous bone marrow mononuclear cell transplantation

Interventions

Autologous bone marrow mononuclear cell transplantationPROCEDURE

Intrathecal autologous bone marrow mononuclear cell transplantation

Stem cell

Eligibility Criteria

Age6 Months - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurogen brain and spine institute

Mumbai, Maharashtra, 400071, India

Location

Related Publications (1)

  • 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.

    PMID: 19364066BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 4, 2013

Study Start

August 1, 2009

Primary Completion

January 1, 2016

Study Completion

May 1, 2016

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)