Mental RetardationPhase 1/2NCT01908400
Safety and Efficacy of BMMNCin Patients With Mental Retardation
A Phase 1/2 study testing Intravenous transfer of BMMNC in people with Mental Retardation, run by Chaitanya Hospital, Pune at 1 site in India.
Trial summary
Mental retardation is a condition diagnosed before age 18 that includes below-average general intellectual function, and a lack of the skills necessary for daily living. Mental retardation affects about 1 - 3% of the population. Read more about this study
- Who is it for?
- Ages 5 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Retardation
- What is being tested?
- Intravenous transfer of BMMNC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2014to Nov 2016
- Phase
- Phase 1/2
- 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 5 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age limit: 5 -50
- Primary diagnosis of mental retardation (IQ < 70)
- willingness to undergo Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) transplantation.
- To give an informed consent as well as sign the required Informed Consent Form (ICF)/video Consent for the study.
- willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
Who cannot join
- Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
- Advanced age that may produce deteriorating cognitive or motor functioning
- Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer
- Poor general health
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Chaitanya Hospital
Pune, Maharashtra, 411030
Sachin P Jamadar, D ORTHO, +918888788880, sac2751982@gmail.com
Anant E Bagul, MS,Ortho
About this study
Official title: An Open Labeled Clinical Study to Evaluate the Safety and Efficacy of Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Patients With Mental Retardation. It is Self Funded (Patients' Own Funding) Clinical Trial
Mental retardation is a condition diagnosed before age 18 that includes below-average general intellectual function, and a lack of the skills necessary for daily living. Mental retardation affects about 1 - 3% of the population. There are many causes of mental retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells are used in this condition to prove its safety and efficacy .
- Conditions
- Mental Retardation
- Being tested
- Intravenous transfer of BMMNC
- Keywords
- Mental retardation , stem cell,BMMNC
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous transfer of BMMNCBiological
Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
| Study group | Role | What they receive |
|---|---|---|
| BMMNCs | Other | Intravenous transfer of (BMMNCs) Receives: Biological: Intravenous transfer of BMMNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binet-Kamat Test
CHANGE in IQ as measured by Binet-Kamat Test
Measured: 1 YEAR
Secondary outcomes (1)
Vineland Social Maturity Scale
CHANGE in Social Quotient as measured by Vineland Social Maturity Scale
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startSep 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaitanya Hospital, Pune
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sachin Jamadar, Chaitanya Hospital, Pune
- Investigators
- ANANT E BAGUL, MS ORTHO, Principal investigator, Chaitanya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908400
- Sponsor's protocol ID
- CSCC/BMMR/2013//01
- Status last verified
- Sep 2014
- First submitted
- 23 Jul 2013
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Labeled Clinical Study to Evaluate the Safety and Efficacy of Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Patients With Mental Retardation. It is Self Funded (Patients' Own Funding) Clinical Trial
- ClinicalTrials.gov ID
- NCT01908400
- Acronym / sponsor ID
- CSCC/BMMR/2013//01
- Conditions
- Mental Retardation
- Keywords
- Mental retardation , stem cell,BMMNC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chaitanya Hospital, PuneUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 25 Jul 2013 (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.
Mental retardation is a condition diagnosed before age 18 that includes below-average general intellectual function, and a lack of the skills necessary for daily living. Mental retardation affects about 1 - 3% of the population. There are many causes of mental retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells are used in this condition to prove its safety and efficacy .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMMNCs | Other | Biological: Intravenous transfer of BMMNCIntravenous transfer of (BMMNCs) |
Who may qualify
- Ages
- 5 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age limit: 5 -50
- Primary diagnosis of mental retardation (IQ < 70)
- willingness to undergo Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) transplantation.
- To give an informed consent as well as sign the required Informed Consent Form (ICF)/video Consent for the study.
- willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
Key exclusion criteria (4 listed)
- Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
- Advanced age that may produce deteriorating cognitive or motor functioning
- Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer
- Poor general health
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 |
|---|---|---|
| Intravenous transfer of BMMNCIntervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) | Biological | BMMNCs |
Primary outcome
Binet-Kamat Test
Time frame: 1 YEAR
CHANGE in IQ as measured by Binet-Kamat Test
1 secondary outcome
Vineland Social Maturity Scale
Time frame: baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
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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.
ANANT E BAGUL, MS ORTHO principal investigator
Chaitanya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravenous transfer of BMMNC in people with Mental Retardation, run by Chaitanya Hospital, Pune 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Sep 2014. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sachin P Jamadar, D.Ortho (918888788880, sac2751982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binet-Kamat Test (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 17 Sep 2014.