Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS

July 2, 2016 updated by: Royan Institute

Safety of Intravenous Transplantation 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

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

6

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 65 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 reciepient
the patients with ALS who underwent intravenous injection of mesenchymal stem cell.
Biological: intra venous injection of stem cell
Intra venous injection of mesenchymal stem cell
Other Names:
  • Stem cell transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fever
Time Frame: 48hours
Evaluation the rate of fever 48 hours after cell transplantation
48hours
Unconsciousness
Time Frame: 48hours
Evaluation the rate of unconsciousness 48hours after cell transplantation.
48hours
vomiting
Time Frame: 48hours
Evaluation the rate of vomiting 48hours after cell transplantation.
48hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALS-FRS
Time Frame: 6months
Evaluation the improvement of ALS-FRS during 6months after cell transplantation.
6months
FVC
Time Frame: 6months
Evaluation the improvement of FVC (spectrometry )in patients after cell transplantation.
6months
EMG-NCV
Time Frame: 6months
Evaluation the improvement of EMG-NCV during 6 months after cell transplantation.
6months

Collaborators and Investigators

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

Sponsor

Royan Institute

Investigators

  • Study Director: Nasser Aghdami, MD,PhD, Head of Royan department of degenerative medicine,Head of Royan celltherapy center
  • Study Director: Seyed Masoud Nabavi, MD, Proffessor assistant of Shahed 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.

General Publications

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

January 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 31, 2012

First Submitted That Met QC Criteria

January 2, 2013

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 2, 2016

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Nerve-005

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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