Mental RetardationPhase 1NCT02245724
Stem Cell Therapy in Mental Retardation
A Phase 1 study testing Stem Cell in people with Mental Retardation, run by Neurogen Brain and Spine Institute at 1 site in India.
Trial summary
The purpose of this study was to analyze the benefit of autologous mononuclear cell therapy in mental retardation. Read more about this study
- Who is it for?
- Ages 6 months to 40 years
- Conditions the study is for
- Mental Retardation
- 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
- Sep 2011to 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed cases of mental retardation
- 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 10Show fewer
- severe anemia [Hemoglobin < 8]
- any bone marrow disorder
- space occupying lesion in brain
- other acute medical conditions such as respiratory infection and pyrexia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to analyze the benefit of autologous mononuclear cell therapy in mental retardation.
- Conditions
- Mental Retardation
- Being tested
- Stem Cell
- Keywords
- Mental retardation, Autologous mononuclear cell therapy, Stem cell
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem CellBiological
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 common clinical symptoms of mental retardation
Change in symptoms such as cognition, remote memory, problem solving,understanding of relationships,social interaction,communication,self care, activities of daily living will be recorded at 1 year follow up.
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 startSep 2011
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental RetardationStudies 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
- NCT02245724
- Sponsor's protocol ID
- NGBSI-15
- 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
Publications
Sharma A, Sane H, Gokulchandran N, Pai S, Kulkarni P, Ganwir V, Maheshwari M, Sharma R, Raichur M, Nivins S, Badhe P. An open-label proof-of-concept study of intrathecal autologous bone marrow mononuclear cell transplantation in intellectual disability. Stem Cell Res Ther. 2018 Jan 31;9(1):19. doi: 10.1186/s13287-017-0748-2.
PubMed 29386049
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
- Stem Cell Therapy in Mental Retardation
- ClinicalTrials.gov ID
- NCT02245724
- Acronym / sponsor ID
- NGBSI-15
- Conditions
- Mental Retardation
- Keywords
- Mental retardation, Autologous mononuclear cell therapy, Stem cell
- 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
- Sep 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- 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 this study was to analyze the benefit of autologous mononuclear cell therapy in mental retardation.
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 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- diagnosed cases of mental retardation
- age above 6 months
Key exclusion criteria (10 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 CellAutologous bone marrow mononuclear cell transplantation | Biological | Stem Cell |
Primary outcome
Change in common clinical symptoms of mental retardation
Time frame: 1 year
Change in symptoms such as cognition, remote memory, problem solving,understanding of relationships,social interaction,communication,self care, activities of daily living will be recorded at 1 year follow up.
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.
- Derived from this study: PubMed 29386049Sharma A, Sane H, Gokulchandran N, Pai S, Kulkarni P, Ganwir V, Maheshwari M, Sharma R, Raichur M, Nivins S, Badhe P. An open-label proof-of-concept study of intrathecal autologous bone marrow mononuclear cell transplantation in intellectual disability. Stem Cell Res Ther. 2018 Jan 31;9(1):19. doi: 10.1186/s13287-017-0748-2.
- 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 Mental Retardation, 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 10 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 common clinical symptoms of mental retardation (time frame: 1 year). 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 NCT02245724, 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 25 Oct 2018; AzTrials last refreshed its copy on 28 Oct 2026.