Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

April 26, 2017 updated by: Royan Institute

Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS

Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only therapeutic option now. Recently several studies have shown that stem cell transplantation is safe and can be effective in reduction of disease progression and increase of quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the study is perform with 8 patients who has sporadic form of ALS with(ALS-Functional Rating Test) ALS-FRS> 24 and (Forced Vital Capacity) FVC>40% . The adipose sample is provide from healthy donors with abdominal lipoaspiration. After isolation and culture of mesenchymal stem cells, the cells are injected intravenously (2 million cells/kg). All the patients will be followed for 12 months at 72hours, 2months, 4 months, 6 months and 12 months after transplantation to find the adverse events. During follow up the assessments including: ALS-FRS, FVC and electromyography and serologic tests.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • 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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both gender
  • Age: 18-55
  • Sporadic form of disease
  • ALS-FRS> = 24
  • FVC >= 40%

Exclusion Criteria:

  • Familial form of ALS
  • Malignancy
  • Autoimmune disease
  • Diagnosis of other motor neuron diseases

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: Stem cell
The patients with diagnosis of ALS who receive adipose derived mesenchymal stem cell.
Biological: mesenchymal stem cells
mesenchymal stem cells injection via peripheral vein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fever
Time Frame: 72hours
The increase of body temperature that is defined as fever, within 72 hours after injection.
72hours
Unconsciousness
Time Frame: 72hours
Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.
72hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)
Time Frame: 2 months
Evaluation the improvement of ALS functional rating scale ( ALS-FRS) by ALS-FRS questionnare, 2 months after cell injection.
2 months
FVC
Time Frame: 2 months
Evaluation the improvement of FVC by spirometry, 2 months after cell injection.
2 months

Collaborators and Investigators

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

Sponsor

Royan Institute

Investigators

  • Study Director: Nasser Aghdami, MD,PhD, Head of department of Regenerative Medicine,Royasn Institute
  • Study Director: Masood Nabavi, MD, Professor associated of neurology, Shahed University
  • Principal Investigator: Leila Arab, MD, Department of Regenerative Medicine, Royan Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

September 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Nerve-008

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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