Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS

Safety of Intravenous Transplantation of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01759797

Enrollment

Registered

2013-01-03

Start date

2013-01-31

Completion date

2014-03-31

Last updated

2016-07-06

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 bone marrow mesenchymal stem cell intravenous injection

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

BIOLOGICALintra venous injection of stem cell

Intra venous injection of mesenchymal stem cell

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 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 48 hours after cell transplantation
Unconsciousness	48hours	Evaluation the rate of unconsciousness 48hours after cell transplantation.
vomiting	48hours	Evaluation the rate of vomiting 48hours after cell transplantation.

Secondary

Measure	Time frame	Description
ALS-FRS	6months	Evaluation the improvement of ALS-FRS during 6months after cell transplantation.
FVC	6months	Evaluation the improvement of FVC (spectrometry )in patients after cell transplantation.
EMG-NCV	6months	Evaluation the improvement of EMG-NCV during 6 months after cell transplantation.

Countries

Iran

Outcome results

None listed

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