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NCT Number: NCT01759797

Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS

ALS is a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment that has been found to improve survival but only to a modest extent. It lengthens survival by several months, and may have a greater survival benefit for those with a bulbar onset. It also extends the time before a person needs ventilation support.Stem cell transplantation is a new hopeful way to improve the patients conditions and reduce the period of disabilities.

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute

Tehran, Iran

About this study

In this study our purpose is to evaluate the safety of intraventricular injection of bone marrow derived mesenchymal stem cell.the patients who are eligible,underwent bone marrow aspiration.after cell separation and preparation,the patients underwent mesenchymal stem cell intraventricular injection by stereotaxis.after injection he will be under observed in ICU to monitor the adverse events(allergic and neurological side effects).patients are followed 1th,3th ,6th and 12 months after injection and each time these parameters are checked:ALS-FRS,EMG-NCV,FVC,side effect check list.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • - Age:18-65
  • both gender
  • duration of disease<2 years
  • FVC>40% ALS-FRS>26

Exclusion criteria

  • - neurological and psychiatric concomitant disease
  • concomitant systemic disease
  • treatment with corticosteroid,Ig,immunosuppressive during 12 months.

Treatment and study plan

intra venous injection of stem cell

Biological

Intra venous injection of mesenchymal stem cell

Other names: Stem cell transplantation

Primary outcomes

  1. Fever

    Time frame: 48hours

    Evaluation the rate of fever 48 hours after cell transplantation

  2. Unconsciousness

    Time frame: 48hours

    Evaluation the rate of unconsciousness 48hours after cell transplantation.

  3. vomiting

    Time frame: 48hours

    Evaluation the rate of vomiting 48hours after cell transplantation.

Secondary outcomes

  1. ALS-FRS

    Time frame: 6months

    Evaluation the improvement of ALS-FRS during 6months after cell transplantation.

  2. FVC

    Time frame: 6months

    Evaluation the improvement of FVC (spectrometry )in patients after cell transplantation.

  3. EMG-NCV

    Time frame: 6months

    Evaluation the improvement of EMG-NCV during 6 months after cell transplantation.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

Safety of Intravenous Transplantation of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 3, 2013
Registry last updated
Jul 6, 2016

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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