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Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS
This study has been completed.
Sponsor:
Royan Institute
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01771640
First received: January 16, 2013
Last updated: December 31, 2015
Last verified: May 2012
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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: 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:
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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01771640
Please refer to this study by its ClinicalTrials.gov identifier: 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:
| Responsible Party: | Royan Institute |
| ClinicalTrials.gov Identifier: | NCT01771640 History of Changes |
| Other Study ID Numbers: |
Royan-Nerve-006 |
| Study First Received: | January 16, 2013 |
| Last Updated: | December 31, 2015 |
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 |
ClinicalTrials.gov processed this record on June 22, 2017