Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759797
• Other study ID #: Royan-Nerve-005
• Status: Completed
• Phase: Phase 1
• First received: December 31, 2012
• Last updated: July 2, 2016
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2012
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• 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: 6
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis

Intervention

Biological:
• intra venous injection of stem cell
Intra venous injection of mesenchymal stem cell

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 48 hours after cell transplantation	48hours	Yes
Primary	Unconsciousness	Evaluation the rate of unconsciousness 48hours after cell transplantation.	48hours	Yes
Primary	vomiting	Evaluation the rate of vomiting 48hours after cell transplantation.	48hours	Yes
Secondary	ALS-FRS	Evaluation the improvement of ALS-FRS during 6months after cell transplantation.	6months	No
Secondary	FVC	Evaluation the improvement of FVC (spectrometry )in patients after cell transplantation.	6months	No
Secondary	EMG-NCV	Evaluation the improvement of EMG-NCV during 6 months after cell transplantation.	6months	No

External Links

•   Link