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Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS

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ClinicalTrials.gov Identifier: NCT02492516
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Biological: mesenchymal stem cells Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
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
Actual Study Start Date : September 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 2017

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Arms and Interventions
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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.


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

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


Eligibility Criteria
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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
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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
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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
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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
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Additional Information:

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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02492516    
Other Study ID Numbers: Royan-Nerve-008
First Posted: July 8, 2015    Key Record Dates
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:
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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