Neurological; Disorder, Nervous SystemPhase 1NCT02245776
Stem Cell Therapy in Incurable Neurological Disorders
A Phase 1 study testing Stem Cell in people with Neurological; Disorder, Nervous System, run by Neurogen Brain and Spine Institute at 1 site in India.
Trial summary
The purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in incurable neurological disorders. Read more about this study
- Who is it for?
- Ages 6 months to 80 years
- Conditions the study is for
- Neurological; Disorder, Nervous System
- 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 Dec 2018
- 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 6 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed cases of incurable neurological disorders
- age above 6 months
Who cannot join
- presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
- malignancies
- bleeding tendencies
- pneumonia
- renal failure
- severe liver dysfunction
Show all 12Show fewer
- severe anemia [Hemoglobin < 8]
- any bone marrow disorder
- space occupying lesion in brain
- other acute medical conditions such as respiratory infection and pyrexia
- pregnancy
- lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Bone Marrow Mononuclear Cell Therapy for Incurable Neurological Disorders
The purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in incurable neurological disorders.
- Conditions
- Neurological; Disorder, Nervous System
- Being tested
- Stem Cell
- Keywords
- Incurable Neurological Disorders, Autologous mononuclear cell therapy, Stem cells
- Medical subject headings
- Neurologic Manifestations
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.
Change in various clinical symptoms of neurological disorders
Change in various symptoms such as muscle strength, limb strength, ambulation, neck holding, bladder bowel management, spasticity, sensation, speech, etc depending on the disorder will be recorded at 1 year follow up. Percentage analysis of each symptom will be carried out to study the benefits of stem cell therapy on them.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startDec 2008
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological; Disorder, Nervous SystemStudies 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
- NCT02245776
- Sponsor's protocol ID
- NGBSI-16
- 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
- Autologous Bone Marrow Mononuclear Cell Therapy for Incurable Neurological Disorders
- ClinicalTrials.gov ID
- NCT02245776
- Acronym / sponsor ID
- NGBSI-16
- Conditions
- Neurological; Disorder, Nervous System
- Keywords
- Incurable Neurological Disorders, 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
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 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 purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in incurable neurological disorders.
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
- 6 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed cases of incurable neurological disorders
- age above 6 months
Key exclusion criteria (12 listed)
- presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
- 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
Change in various clinical symptoms of neurological disorders
Time frame: 1 year
Change in various symptoms such as muscle strength, limb strength, ambulation, neck holding, bladder bowel management, spasticity, sensation, speech, etc depending on the disorder will be recorded at 1 year follow up. Percentage analysis of each symptom will be carried out to study the benefits of stem cell therapy on them.
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 Neurological; Disorder, Nervous System, 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 12 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?
Change in various clinical symptoms of neurological disorders (time frame: 1 year). 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.