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Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01771640

First Posted: January 18, 2013

Last Update Posted: January 1, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Royan Institute

Purpose

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.

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis	Biological: intrathecal injection	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Intrathecal Transplantation of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Further study details as provided by Royan Institute:

Primary Outcome Measures:

Fever [ Time Frame: 48hours ]
Evaluation the rate of fever during 48hour after transplantation
Unconscious [ Time Frame: 48hours ]
Evaluation the rate of unconsciousness during 48hour after transplantation
Vomiting [ Time Frame: 48hours ]
Evaluation the nausea and vomiting 48hours after transplantation.

Secondary Outcome Measures:

ALS-FRS [ Time Frame: 6months ]
Evaluation the improvement of ALS-FRS during 6months after transplantation.
FVC [ Time Frame: 6months ]
Evaluation the improvement of FVC by spirometry during 6months after transplantation


Enrollment:	8
Study Start Date:	August 2013
Study Completion Date:	December 2014
Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: stem cell reciepient The patients with ALS that underwent mesenchymal stem cell transplantation	Biological: intrathecal injection Intrathecal injection of mesenchymal stem cells in patients with ALS

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771640

Locations


Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Royan Institute

Investigators


Study Chair:	Hamid Gourabi, PhD	Head of Royan Institute
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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


Responsible Party:	Royan Institute
ClinicalTrials.gov Identifier:	NCT01771640 History of Changes
Other Study ID Numbers:	Royan-Nerve-006
First Submitted:	January 16, 2013
First Posted:	January 18, 2013
Last Update Posted:	January 1, 2016
Last Verified:	May 2012

Keywords provided by Royan Institute:


ALS intrathecal injection bone marrow mesenchymal stem cell

Additional relevant MeSH terms:


Motor Neuron Disease Amyotrophic Lateral Sclerosis Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases	Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases

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