Traumatic Brain InjuryPhase 1NCT02028104
Stem Cell Therapy in Traumatic Brain Injury
A Phase 1 study testing Autologous bone marrow mononuclear cell transplantation in people with Traumatic Brain Injury, run by Neurogen Brain and Spine Institute at 1 site in India.
Trial summary
The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with Traumatic Brain Injury Read more about this study
- Who is it for?
- Ages 6 months to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Autologous bone marrow mononuclear cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2010to 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 6 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed cases of chronic traumatic brain injury
- 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: Open Label Study of Autologous Bone Marrow Mononuclear Cells in Traumatic Brain Injury
The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with Traumatic Brain Injury
- Conditions
- Traumatic Brain Injury
- Being tested
- Autologous bone marrow mononuclear cell transplantation
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow mononuclear cell transplantationBiological
bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients
| Study group | Role | What they receive |
|---|---|---|
| stem cells | Experimental | autologous bone marrow mononuclear cell transplantation Receives: Biological: Autologous bone marrow mononuclear cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical symptoms of traumatic brain injury
Measured: 6 months
Secondary outcomes (1)
Disability Rating scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJan 2010
- Primary completionApr 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies 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
- Investigators
- Alok K Sharma, M.S., M.Ch, Principal investigator, Neurogen Brain and Spine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028104
- Sponsor's protocol ID
- NGBSI-06
- Status last verified
- Oct 2018
- First submitted
- 3 Jan 2014
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lee DH, Lee JY, Oh BM, Phi JH, Kim SK, Bang MS, Kim SU, Wang KC. Functional recovery after injury of motor cortex in rats: effects of rehabilitation and stem cell transplantation in a traumatic brain injury model of cortical resection. Childs Nerv Syst. 2013 Mar;29(3):403-11. doi: 10.1007/s00381-012-1969-4. Epub 2012 Nov 24.
PubMed 23180314Tian C, Wang X, Wang X, Wang L, Wang X, Wu S, Wan Z. Autologous bone marrow mesenchymal stem cell therapy in the subacute stage of traumatic brain injury by lumbar puncture. Exp Clin Transplant. 2013 Apr;11(2):176-81. doi: 10.6002/ect.2012.0053. Epub 2012 Aug 11.
PubMed 22891928
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
- Open Label Study of Autologous Bone Marrow Mononuclear Cells in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02028104
- Acronym / sponsor ID
- NGBSI-06
- Conditions
- Traumatic Brain Injury
- 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
- Jan 2010
- Primary completion
- Apr 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Jan 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 this study was to study the effect of stem cell therapy on common symptoms in patients with Traumatic Brain Injury
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stem cells | Experimental | Biological: Autologous bone marrow mononuclear cell transplantationautologous bone marrow mononuclear cell transplantation |
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed cases of chronic traumatic brain injury
- 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 |
|---|---|---|
| Autologous bone marrow mononuclear cell transplantationbone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients | Biological | stem cells |
Primary outcome
Change in clinical symptoms of traumatic brain injury
Time frame: 6 months
1 secondary outcome
Disability Rating scale
Time frame: 6 months
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.
- Background: PubMed 23180314Lee DH, Lee JY, Oh BM, Phi JH, Kim SK, Bang MS, Kim SU, Wang KC. Functional recovery after injury of motor cortex in rats: effects of rehabilitation and stem cell transplantation in a traumatic brain injury model of cortical resection. Childs Nerv Syst. 2013 Mar;29(3):403-11. doi: 10.1007/s00381-012-1969-4. Epub 2012 Nov 24.
- Background: PubMed 22891928Tian C, Wang X, Wang X, Wang L, Wang X, Wu S, Wan Z. Autologous bone marrow mesenchymal stem cell therapy in the subacute stage of traumatic brain injury by lumbar puncture. Exp Clin Transplant. 2013 Apr;11(2):176-81. doi: 10.6002/ect.2012.0053. Epub 2012 Aug 11.
- 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.
Alok K Sharma, M.S., M.Ch principal investigator
Neurogen Brain and Spine Institute
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 Autologous bone marrow mononuclear cell transplantation in people with Traumatic Brain Injury, 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 clinical symptoms of traumatic brain injury (time frame: 6 months). 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 NCT02028104, which also lists 2 linked publications.
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.