Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS

Safety of Intraventricular Injection of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01759784

Enrollment

Registered

2013-01-03

Start date

2014-03-31

Completion date

Unknown

Last updated

2016-01-01

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

Conditions

Amyotrophic Lateral Sclerosis

Keywords

mesenchymal stem cell intraventricular injection ALS

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

BIOLOGICALIntraventricular injection

intraventricular injection of mesenchymal stem cell by stereo taxi in patients with ALS

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Measure	Time frame	Description
fever	48hours	evaluation the rate of fever 48hours after stem cell injection
unconsciousness	6months	evaluation the rate of unconsciousness during 6months after stem cell injection.
brain hematoma	48hours	Evaluation the rate of hematoma 48hours after stem cell injection.
vomiting	48hours	evaluation the rate of vomiting 48hours after stem cell injection.

Secondary

Measure	Time frame	Description
ALS-FRS	6months	evaluation the improvement of ALS-FRS 6months after stem cell injection.
EMG-NCV	6months	evaluation the improvement of EMG-NCV after stem cell injection.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026