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Amyotrophic Lateral SclerosisPhase 1NCT01759797

Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS

A Phase 1 study testing intra venous injection of stem cell in people with Amyotrophic Lateral Sclerosis, run by Royan Institute at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Amyotrophic Lateral Sclerosis
What is being tested?
intra venous injection of stem cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteIran
Study dates
Jan 2013to Mar 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Royan Institute

    Tehran

Other trials in Iran

About this study

Official title: Safety of Intravenous Transplantation of Bone Marrow Derived 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.

Read the 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.

Being tested
intra venous injection of stem cell
Keywords
ALS bone marrow mesenchymal stem cell intravenous injection
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intra venous injection of stem cellBiological

    Also called Stem cell transplantation

    Intra venous injection of mesenchymal stem cell

Study groups in NCT01759797
Study groupRoleWhat they receive
stem cell reciepientExperimentalthe patients with ALS who underwent intravenous injection of mesenchymal stem cell.
Receives: Biological: intra venous injection of stem cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fever

    Evaluation the rate of fever 48 hours after cell transplantation

    Measured: 48hours

  2. Unconsciousness

    Evaluation the rate of unconsciousness 48hours after cell transplantation.

    Measured: 48hours

  3. vomiting

    Evaluation the rate of vomiting 48hours after cell transplantation.

    Measured: 48hours

Secondary outcomes (3)

  1. ALS-FRS

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

    Measured: 6months

  2. FVC

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

    Measured: 6months

  3. EMG-NCV

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

    Measured: 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJan 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01759797
Sponsor's protocol ID
Royan-Nerve-005
Status last verified
May 2012
First submitted
31 Dec 2012
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30124008

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing intra venous injection of stem cell in people with Amyotrophic Lateral Sclerosis, run by Royan Institute at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fever (time frame: 48hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01759797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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