Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
intrathecal injection
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS intrathecal injection bone marrow mesenchymal stem cell
Eligibility 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.
Sites / Locations
- Royan Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stem cell reciepient
Arm Description
The patients with ALS that underwent mesenchymal stem cell transplantation
Outcomes
Primary Outcome Measures
Fever
Evaluation the rate of fever during 48hour after transplantation
Unconscious
Evaluation the rate of unconsciousness during 48hour after transplantation
Vomiting
Evaluation the nausea and vomiting 48hours after transplantation.
Secondary Outcome Measures
ALS-FRS
Evaluation the improvement of ALS-FRS during 6months after transplantation.
FVC
Evaluation the improvement of FVC by spirometry during 6months after transplantation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01771640
Brief Title
Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS
Official Title
Intrathecal Transplantation of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS intrathecal injection bone marrow mesenchymal stem cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stem cell reciepient
Arm Type
Experimental
Arm Description
The patients with ALS that underwent mesenchymal stem cell transplantation
Intervention Type
Biological
Intervention Name(s)
intrathecal injection
Intervention Description
Intrathecal injection of mesenchymal stem cells in patients with ALS
Primary Outcome Measure Information:
Title
Fever
Description
Evaluation the rate of fever during 48hour after transplantation
Time Frame
48hours
Title
Unconscious
Description
Evaluation the rate of unconsciousness during 48hour after transplantation
Time Frame
48hours
Title
Vomiting
Description
Evaluation the nausea and vomiting 48hours after transplantation.
Time Frame
48hours
Secondary Outcome Measure Information:
Title
ALS-FRS
Description
Evaluation the improvement of ALS-FRS during 6months after transplantation.
Time Frame
6months
Title
FVC
Description
Evaluation the improvement of FVC by spirometry during 6months after transplantation
Time Frame
6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of Royan department of degenerative medicine,Head of Royan celltherapy center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seyed Masoud Nabavi, MD
Organizational Affiliation
Proffessor assistant of Shahed University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
leila Arab, MD
Organizational Affiliation
Department of regenerative medicine,Royan Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
30124008
Citation
Nabavi SM, Arab L, Jarooghi N, Bolurieh T, Abbasi F, Mardpour S, Azimyian V, Moeininia F, Maroufizadeh S, Sanjari L, Hosseini SE, Aghdami N. Safety, Feasibility of Intravenous and Intrathecal Injection of Autologous Bone Marrow Derived Mesenchymal Stromal Cells in Patients with Amyotrophic Lateral Sclerosis: An Open Label Phase I Clinical Trial. Cell J. 2019 Jan;20(4):592-598. doi: 10.22074/cellj.2019.5370. Epub 2018 Aug 1.
Results Reference
derived
Links:
URL
http://Royaninstitute.org
Description
Related Info
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Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS
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