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Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

intra venous injection of stem cell

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS bone marrow mesenchymal stem cell intravenous injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Royan Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stem cell reciepient

Arm Description

the patients with ALS who underwent intravenous injection of mesenchymal stem cell.

Outcomes

Primary Outcome Measures

Fever

Evaluation the rate of fever 48 hours after cell transplantation

Unconsciousness

Evaluation the rate of unconsciousness 48hours after cell transplantation.

vomiting

Evaluation the rate of vomiting 48hours after cell transplantation.

Secondary Outcome Measures

ALS-FRS

Evaluation the improvement of ALS-FRS during 6months after cell transplantation.

FVC

Evaluation the improvement of FVC (spectrometry )in patients after cell transplantation.

EMG-NCV

Evaluation the improvement of EMG-NCV during 6 months after cell transplantation.

Full Information

NCT ID

NCT01759797

First Posted

December 31, 2012

Last Updated

July 2, 2016

Sponsor

Royan Institute

1. Study Identification

Unique Protocol Identification Number

NCT01759797

Brief Title

Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

Keywords

ALS bone marrow mesenchymal stem cell intravenous injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

stem cell reciepient

Arm Type

Experimental

Arm Description

the patients with ALS who underwent intravenous injection of mesenchymal stem cell.

Intervention Type

Biological

Intervention Name(s)

intra venous injection of stem cell

Other Intervention Name(s)

Stem cell transplantation

Intervention Description

Intra venous injection of mesenchymal stem cell

Primary Outcome Measure Information:

Title

Fever

Description

Evaluation the rate of fever 48 hours after cell transplantation

Time Frame

48hours

Title

Unconsciousness

Description

Evaluation the rate of unconsciousness 48hours after cell transplantation.

Time Frame

48hours

Title

vomiting

Description

Evaluation the rate of vomiting 48hours after cell transplantation.

Time Frame

48hours

Secondary Outcome Measure Information:

Title

ALS-FRS

Description

Evaluation the improvement of ALS-FRS during 6months after cell transplantation.

Time Frame

6months

Title

FVC

Description

Evaluation the improvement of FVC (spectrometry )in patients after cell transplantation.

Time Frame

6months

Title

EMG-NCV

Description

Evaluation the improvement of EMG-NCV during 6 months after cell transplantation.

Time Frame

6months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamid Gourabi, PhD

Organizational Affiliation

Head of Royan Institute

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Nasser Aghdami, MD,PhD

Organizational Affiliation

Head of Royan department of degenerative medicine,Head of Royan celltherapy center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Seyed Masoud Nabavi, MD

Organizational Affiliation

Proffessor assistant of Shahed University

Official's Role

Study Director

Facility Information:

Facility Name

Royan Institute

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

30124008

Citation

Nabavi SM, Arab L, Jarooghi N, Bolurieh T, Abbasi F, Mardpour S, Azimyian V, Moeininia F, Maroufizadeh S, Sanjari L, Hosseini SE, Aghdami N. Safety, Feasibility of Intravenous and Intrathecal Injection of Autologous Bone Marrow Derived Mesenchymal Stromal Cells in Patients with Amyotrophic Lateral Sclerosis: An Open Label Phase I Clinical Trial. Cell J. 2019 Jan;20(4):592-598. doi: 10.22074/cellj.2019.5370. Epub 2018 Aug 1.

Results Reference

derived

Links:

URL

http://Royaninstitute.org

Description

Related Info

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Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS

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