- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01759784
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Withdrawn
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
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
-
-
-
Tehran, Iran, Islamic Republic of
- Royan Institute
-
-
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:
|
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Royan-Nerve-004
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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