Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771640
• Other study ID #: Royan-Nerve-006
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2013
• Last updated: March 6, 2018
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2012
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

Biological:
• intrathecal injection
Intrathecal injection of mesenchymal stem cells in patients with ALS

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fever	Evaluation the rate of fever during 48hour after transplantation	48hours
Primary	Unconscious	Evaluation the rate of unconsciousness during 48hour after transplantation	48hours
Primary	Vomiting	Evaluation the nausea and vomiting 48hours after transplantation.	48hours
Secondary	ALS-FRS	Evaluation the improvement of ALS-FRS during 6months after transplantation.	6months
Secondary	FVC	Evaluation the improvement of FVC by spirometry during 6months after transplantation	6months

External Links

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