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Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS

Intrathecal Transplantation of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01771640
Enrollment
8
Registered
2013-01-18
Start date
2013-08-31
Completion date
2014-12-31
Last updated
2018-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS intrathecal injection bone marrow mesenchymal stem cell

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.

Interventions

Intrathecal injection of mesenchymal stem cells in patients with ALS

Sponsors

Royan Institute
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Fever48hoursEvaluation the rate of fever during 48hour after transplantation
Unconscious48hoursEvaluation the rate of unconsciousness during 48hour after transplantation
Vomiting48hoursEvaluation the nausea and vomiting 48hours after transplantation.

Secondary

MeasureTime frameDescription
ALS-FRS6monthsEvaluation the improvement of ALS-FRS during 6months after transplantation.
FVC6monthsEvaluation the improvement of FVC by spirometry during 6months after transplantation

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026