Amyotrophic Lateral SclerosisPhase 1NCT02242071
Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis
A Phase 1 study testing Stem Cell in people with Amyotrophic Lateral Sclerosis, run by Neurogen Brain and Spine Institute at 1 site in India.
Trial summary
The effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic Lateral Sclerosis patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Stem Cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2008to Sep 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the diagnosis of definite Motor Neuron Disease/amyotrophic lateral sclerosis.
- Age 18-80 years
Who cannot join
- HIV/HBV/HCV
- Malignancies
- Bleeding tendencies
- Pneumonia
- Renal failure
- Severe liver dysfunction
Show all 13Show fewer
- Severe anemia [hb < 8]
- Any bone marrow disorder
- Space occupying lesion in brain
- Pregnancy and lactation
- Other acute medical conditions/infections such as respiratory infection and pyrexia
- left ventricular ejection fraction < 25%
- Patient on artificial ventilatory support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on Motor Neuron Disease/Amyotrophic Lateral Sclerosis
The effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic Lateral Sclerosis patients.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Stem Cell
- Keywords
- Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Autologous Mononuclear Cell therapy, Stem cells
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem CellBiological
intrathecal autologous bone marrow mononuclear cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell | Experimental | bone marrow mononuclear cell transplantation Receives: Biological: Stem Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyotrophic Lateral Sclerosis Functional rating scale-revised
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startDec 2008
- Primary completionMar 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurogen Brain and Spine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242071
- Sponsor's protocol ID
- NGBSI-10
- Status last verified
- Oct 2018
- First submitted
- 12 Sep 2014
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on Motor Neuron Disease/Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT02242071
- Acronym / sponsor ID
- NGBSI-10
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Autologous Mononuclear Cell therapy, Stem cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neurogen Brain and Spine InstituteUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Mar 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic Lateral Sclerosis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell | Experimental | Biological: Stem Cellbone marrow mononuclear cell transplantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with the diagnosis of definite Motor Neuron Disease/amyotrophic lateral sclerosis.
- Age 18-80 years
Key exclusion criteria (13 listed)
- HIV/HBV/HCV
- Malignancies
- Bleeding tendencies
- Pneumonia
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem Cellintrathecal autologous bone marrow mononuclear cell transplantation | Biological | Stem Cell |
Primary outcome
Amyotrophic Lateral Sclerosis Functional rating scale-revised
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stem Cell in people with Amyotrophic Lateral Sclerosis, run by Neurogen Brain and Spine Institute at 1 site in India.
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 2 inclusion and 13 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: withdrawn, as of the sponsor's last update on 25 Oct 2018. 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 India. 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 was withdrawn before enrolling participants, so there are no results.
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?
Amyotrophic Lateral Sclerosis Functional rating scale-revised (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2018.