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Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02492516
First Posted: July 8, 2015
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Royan Institute
  Purpose
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.

Condition Intervention Phase
Amyotrophic Lateral Sclerosis Biological: mesenchymal stem cells Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • fever [ Time Frame: 72hours ]
    The increase of body temperature that is defined as fever, within 72 hours after injection.

  • Unconsciousness [ Time Frame: 72hours ]
    Evaluation the consciousness state of patients within 72 hours after stem cell injection with clinical examination and GCS score.


Secondary Outcome Measures:
  • 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.

  • FVC [ Time Frame: 2 months ]
    Evaluation the improvement of FVC by spirometry, 2 months after cell injection.


Enrollment: 19
Actual Study Start Date: September 2014
Study Completion Date: April 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492516


Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
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
  More Information

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02492516     History of Changes
Other Study ID Numbers: Royan-Nerve-008
First Submitted: June 24, 2015
First Posted: July 8, 2015
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by Royan Institute:
adipose tissue mesenchymal stem cell intravenous injection ALS

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases