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Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS

Sponsor
Royan Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01771640
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
16
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: intrathecal injection
 Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intrathecal Transplantation of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: stem cell reciepient

The patients with ALS that underwent mesenchymal stem cell transplantation

Biological: intrathecal injection
Intrathecal injection of mesenchymal stem cells in patients with ALS

Outcome Measures

Primary Outcome Measures

  1. Fever [48hours]

    Evaluation the rate of fever during 48hour after transplantation

  2. Unconscious [48hours]

    Evaluation the rate of unconsciousness during 48hour after transplantation

  3. Vomiting [48hours]

    Evaluation the nausea and vomiting 48hours after transplantation.

Secondary Outcome Measures

  1. ALS-FRS [6months]

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

  2. FVC [6months]

    Evaluation the improvement of FVC by spirometry during 6months after transplantation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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 Royan department of degenerative medicine,Head of Royan celltherapy center
  • Study Director: Seyed Masoud Nabavi, MD, Proffessor assistant of Shahed University
  • Principal Investigator: leila Arab, MD, Department of regenerative medicine,Royan Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Royan Institute
ClinicalTrials.gov Identifier:
NCT01771640
Other Study ID Numbers:
  • Royan-Nerve-006
First Posted:
Jan 18, 2013
Last Update Posted:
Mar 7, 2018
Last Verified:
May 1, 2012
Keywords provided by Royan Institute
ALS intrathecal injection bone marrow mesenchymal stem cell
Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis

Study Results

No Results Posted as of Mar 7, 2018