Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

January 13, 2016 updated by: rokhsareh meamar, Alzahra Hospital, Iran

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. sporadic ALS according to escorial criteria
  2. onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
  3. 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
  4. normal polysomnography
  5. Signed consent form

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mesenchymal stem cell
intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline
Biological: mesenchymal stem cell
intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
every 6 months up 2 years after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation
FVC (forced vital capacity)and DWSE±QoL score
Time Frame: before transplantation and every 6 months up 2 years after transplantation
before transplantation and every 6 months up 2 years after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alzahra Hospital, Iran

Investigators

  • Principal Investigator: keivan basiri, MD, Isfahan neurosciences research center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

April 6, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 17, 2014

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rokhsareh
  • stem cell injection in ALS (Other Identifier: iran national science foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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