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NCT Number: NCT02492516

Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for 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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesenchymal stem cells

Biological

mesenchymal stem cells injection via peripheral vein.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 8, 2015
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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