Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS

December 31, 2015 updated by: Royan Institute

Safety of Intraventricular Injection of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS

ALS is a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment that has been found to improve survival but only to a modest extent. It lengthens survival by several months, and may have a greater survival benefit for those with a bulbar onset. It also extends the time before a person needs ventilation support.Stem cell transplantation is a new hopeful way to improve the patients conditions and reduce the period of disabilities.

Study Overview

Status

Withdrawn

Detailed Description

In this study our purpose is to evaluate the safety of intraventricular injection of bone marrow derived mesenchymal stem cell.the patients who are eligible,underwent bone marrow aspiration.after cell separation and preparation,the patients underwent mesenchymal stem cell intraventricular injection by stereotaxis.after injection he will be under observed in ICU to monitor the adverse events(allergic and neurological side effects).patients are followed 1th,3th ,6th and 12 months after injection and each time these parameters are checked:ALS-FRS,EMG-NCV,FVC,side effect check list.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age:18-65
  • both gender
  • duration of disease<2 years
  • FVC>40% ALS-FRS>26

Exclusion Criteria:

  • neurological and psychiatric concomitant disease
  • concomitant systemic disease
  • treatment with corticosteroid,Ig,immunosuppressive during 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stem cell recipient
The patients who underwent mesenchymal stem cell transplantation.
intraventricular injection of mesenchymal stem cell by stereo taxi in patients with ALS
Other Names:
  • intraventricular injection of mesenchymal stem cell by stereotaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fever
Time Frame: 48hours
evaluation the rate of fever 48hours after stem cell injection
48hours
unconsciousness
Time Frame: 6months
evaluation the rate of unconsciousness during 6months after stem cell injection.
6months
brain hematoma
Time Frame: 48hours
Evaluation the rate of hematoma 48hours after stem cell injection.
48hours
vomiting
Time Frame: 48hours
evaluation the rate of vomiting 48hours after stem cell injection.
48hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALS-FRS
Time Frame: 6months
evaluation the improvement of ALS-FRS 6months after stem cell injection.
6months
EMG-NCV
Time Frame: 6months
evaluation the improvement of EMG-NCV after stem cell injection.
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Nasser Aghdami, MD,PhD, Head of Royan department of degenerative medicine,Head of Royan celltherapy center
  • Study Director: Ali Reza Zali, MD, Head of Neurosurgery research center of Shahid Beheshti University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

December 29, 2012

First Submitted That Met QC Criteria

December 31, 2012

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 31, 2015

Last Verified

May 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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