NCT01771640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 7, 2018

Status Verified

May 1, 2012

Enrollment Period

1.2 years

First QC Date

January 16, 2013

Last Update Submit

March 6, 2018

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS intrathecal injection bone marrow mesenchymal stem cell

Outcome Measures

Primary Outcomes (3)

  • Fever

    Evaluation the rate of fever during 48hour after transplantation

    48hours

  • Unconscious

    Evaluation the rate of unconsciousness during 48hour after transplantation

    48hours

  • Vomiting

    Evaluation the nausea and vomiting 48hours after transplantation.

    48hours

Secondary Outcomes (2)

  • ALS-FRS

    6months

  • FVC

    6months

Study Arms (1)

stem cell reciepient

EXPERIMENTAL

The patients with ALS that underwent mesenchymal stem cell transplantation

Biological: intrathecal injection

Interventions

intrathecal injectionBIOLOGICAL

Intrathecal injection of mesenchymal stem cells in patients with ALS

stem cell reciepient

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

  • Nabavi SM, Arab L, Jarooghi N, Bolurieh T, Abbasi F, Mardpour S, Azimyian V, Moeininia F, Maroufizadeh S, Sanjari L, Hosseini SE, Aghdami N. Safety, Feasibility of Intravenous and Intrathecal Injection of Autologous Bone Marrow Derived Mesenchymal Stromal Cells in Patients with Amyotrophic Lateral Sclerosis: An Open Label Phase I Clinical Trial. Cell J. 2019 Jan;20(4):592-598. doi: 10.22074/cellj.2019.5370. Epub 2018 Aug 1.

    PMID: 30124008DERIVED

Related Links

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Injections, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeutics

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

  • Seyed Masoud Nabavi, MD

    Proffessor assistant of Shahed University

    STUDY DIRECTOR

  • leila Arab, MD

    Department of regenerative medicine,Royan Institute

    PRINCIPAL INVESTIGATOR

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

January 16, 2013

First Posted

January 18, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

March 7, 2018

Record last verified: 2012-05

Locations

IR(1)