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Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Withdrawn

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

mesenchymal stem cell

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

sporadic ALS according to escorial criteria
onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount
normal polysomnography
Signed consent form

Exclusion Criteria:

pregnancy or lactation,
vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease
Hospitalization due to serious illness in the last two months
survival time less than two years
Hypersensitivity to any component used in the cell culture

Sites / Locations

Neurosciences Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mesenchymal stem cell

Arm Description

intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline

Outcomes

Primary Outcome Measures

Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS

Secondary Outcome Measures

ALS-FRS(functional rating scale) score and EMG scale

FVC (forced vital capacity)and DWSE±QoL score

Full Information

NCT ID

NCT02116634

First Posted

April 6, 2014

Last Updated

January 13, 2016

Sponsor

Alzahra Hospital, Iran

1. Study Identification

Unique Protocol Identification Number

NCT02116634

Brief Title

Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

Official Title

Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Because economic problems

Study Start Date

May 2015 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alzahra Hospital, Iran

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Whether the mesenchymal injection on ALS patients is effective or not?

Detailed Description

After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.

6. Conditions and Keywords

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

Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mesenchymal stem cell

Arm Type

Experimental

Arm Description

intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline

Intervention Type

Biological

Intervention Name(s)

mesenchymal stem cell

Intervention Description

intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline

Primary Outcome Measure Information:

Title

Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS

Time Frame

every 6 months up 2 years after transplantation

Secondary Outcome Measure Information:

Title

ALS-FRS(functional rating scale) score and EMG scale

Time Frame

before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation

Title

FVC (forced vital capacity)and DWSE±QoL score

Time Frame

before transplantation and every 6 months up 2 years after transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: sporadic ALS according to escorial criteria onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount normal polysomnography Signed consent form Exclusion Criteria: pregnancy or lactation, vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease Hospitalization due to serious illness in the last two months survival time less than two years Hypersensitivity to any component used in the cell culture

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

keivan basiri, MD

Organizational Affiliation

Isfahan neurosciences research center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neurosciences Research Center

City

Isfahan

ZIP/Postal Code

0098311

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

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