Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS

NCT01759784 | Withdrawn Phase 1 DMC

• 1 other identifier: Royan-Nerve-004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

mesenchymal stem cell intraventricular injection ALS

Outcome Measures

Primary Outcomes (4)

• fever

  evaluation the rate of fever 48hours after stem cell injection

  48hours

• unconsciousness

  evaluation the rate of unconsciousness during 6months after stem cell injection.

  6months

• brain hematoma

  Evaluation the rate of hematoma 48hours after stem cell injection.

  48hours

• vomiting

  evaluation the rate of vomiting 48hours after stem cell injection.

  48hours

Secondary Outcomes (2)

• ALS-FRS

  6months

• EMG-NCV

  6months

Study Arms (1)

stem cell recipient

EXPERIMENTAL

The patients who underwent mesenchymal stem cell transplantation.

Biological: Intraventricular injection

Interventions

Intraventricular injection BIOLOGICAL

intraventricular injection of mesenchymal stem cell by stereo taxi in patients with ALS

Also known as: intraventricular injection of mesenchymal stem cell by stereotaxis

stem cell recipient

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Related Info

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Injections, Intraventricular

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Nasser Aghdami, MD,PhD

  Head of Royan department of degenerative medicine,Head of Royan celltherapy center

  STUDY DIRECTOR

• Ali Reza Zali, MD

  Head of Neurosurgery research center of Shahid Beheshti University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2012
• First Posted: January 3, 2013
• Study Start: March 1, 2014
• Primary Completion: March 1, 2017
• Last Updated: January 1, 2016

Record last verified: 2012-05

Locations

IR (1)