Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS
Recruitment status was Recruiting
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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: | Endpoint Classification: Safety Study 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 |
- Fever [ Time Frame: 48hours ] [ Designated as safety issue: Yes ]Evaluation the rate of fever during 48hour after transplantation
- Unconscious [ Time Frame: 48hours ] [ Designated as safety issue: Yes ]Evaluation the rate of unconsciousness during 48hour after transplantation
- Vomiting [ Time Frame: 48hours ] [ Designated as safety issue: Yes ]Evaluation the nausea and vomiting 48hours after transplantation.
- ALS-FRS [ Time Frame: 6months ] [ Designated as safety issue: No ]Evaluation the improvement of ALS-FRS during 6months after transplantation.
- FVC [ Time Frame: 6months ] [ Designated as safety issue: No ]Evaluation the improvement of FVC by spirometry during 6months after transplantation
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01771640
| Contact: Nasser Aghdami, MD,PhD | +9821235622000 ext 504 | nasser.aghdami@royaninstitute.org | |
| Contact: Leila Arab, MD | +982123562000 ext 414 | leara91@gmail.com |
| Iran, Islamic Republic of | |
| Royan Institute | Recruiting |
| Tehran, Iran, Islamic Republic of | |
| Contact: Nasser Aghdami, MD,PhD +982123562000 ext 504 nasser.aghdami@royaninstitute.org | |
| Contact: Leila Arab, MD +982123562000 ext 414 leara91@gmail.com | |
| Principal Investigator: Leila Arab, MD | |
| Sub-Investigator: vagihe azimian, PhD student | |
| Sub-Investigator: Soura Mardpour, MSc | |
| 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:
No publications provided
| 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: | April 24, 2014 |
| Health Authority: | Iran: Ethics Committee Iran: Ministry of Health |
Keywords provided by Royan Institute:
|
ALS intrathecal injection bone marrow mesenchymal stem cell |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases |
Neurodegenerative Diseases Neuromuscular Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies |
ClinicalTrials.gov processed this record on February 25, 2015