Huntington DiseasePhase 1/2BMACHCNCT01834053
Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea.
A Phase 1/2 study testing autologous Stem Cell in people with Huntington Disease, run by Chaitanya Hospital, Pune at 1 site in India.
Trial summary
This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cell {MNC} (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms… Read more about this study
- Who is it for?
- Ages 35 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- autologous Stem Cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2014to Jun 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 35 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient should suffer from Hunting tons Chorea,
- Hunting tons chorea commonly become noticeable between the ages of 35 -44
- Willingness to undergo Bone Marrow derived Autologous cell Therapy.
- Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
- Ability and willingness to regular visit to hospital for protocol procedures and follow up
Who cannot join
- Patient with History of Immunodeficiency HIV+,Hepatitis B virus ( HBV) and History of Life threatening allergic or immune -Mediated Reaction. the site of bone marrow aspiration potentially limiting Procedure.
- alcohol and drug abuse / dependence.
- Severe skin infection.
- Haemodynamically unstable.
- =subject with primary and secondary diabetes , Insulin dependence.
- Neurological disease caused by autoimmune or genetic cause.
- patients suffering from peripheral muscular dystrophy.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Chaitanya Hospital
Pune, Maharashtra, 411009
Sachin P Jamadar, D ORTHO, +918888788880, sac2751982@gmail.com
Smita S Bhoyar, B AMS PGCR, 9372620569, drsmitabhoyar@rediffmail.com
About this study
Official title: Safety and Efficacy of Bone Marrow Derived MNCs for the Treatment of Huntingtons Chorea. It is Self Funded (Patients' Own Funding) Clinical Trial
This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cell {MNC} (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.
Read the detailed description
This study is Single arm, Single Centre trial study the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cells (MNCs) ,to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.
- Conditions
- Huntington Disease
- Being tested
- autologous Stem Cell
- Keywords
- Huntington Disease,stem cell therapy
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous Stem CellBiological
Also called Intrathecal transplantation of autologous MNCs
Intrathecal transplantation of autologous 100 millions Stem cells{MNCs } per dose'
| Study group | Role | What they receive |
|---|---|---|
| STEM CELL | Other | Transfer of autologous Stem cell( MNCs) intrathecally Receives: Biological: autologous Stem Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Cognitive and psychiatric symptoms
Measured: 6 Months
Secondary outcomes (4)
Improvement in neuropsychiatric behaviour
Measured: 6 Months
Increase in life expectancy
Increase in life expectancy.Time period- 6 Months
Measured: 6 Months
Improvement in writhing motions or abnormal posturing
-Improvement in writhing motions or abnormal posturing
Measured: 6 month
Improvement in compulsive behaviour
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startSep 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies 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
- 50 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, M.S, Principal investigator, CHAITANYA HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834053
- Sponsor's protocol ID
- 00106
- Acronym
- BMACHC
- Status last verified
- Sep 2014
- First submitted
- 11 Apr 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
- Safety and Efficacy of Bone Marrow Derived MNCs for the Treatment of Huntingtons Chorea. It is Self Funded (Patients' Own Funding) Clinical Trial
- ClinicalTrials.gov ID
- NCT01834053
- Acronym / sponsor ID
- BMACHC / 00106
- Conditions
- Huntington Disease
- Keywords
- Huntington Disease,stem cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chaitanya Hospital, PuneUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 17 Apr 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.
This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cell {MNC} (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.
Detailed description
This study is Single arm, Single Centre trial study the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cells (MNCs) ,to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.
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 | Other | Biological: autologous Stem CellTransfer of autologous Stem cell( MNCs) intrathecally |
Who may qualify
- Ages
- 35 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient should suffer from Hunting tons Chorea,
- Hunting tons chorea commonly become noticeable between the ages of 35 -44
- Willingness to undergo Bone Marrow derived Autologous cell Therapy.
- Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
- Ability and willingness to regular visit to hospital for protocol procedures and follow up
Key exclusion criteria (7 listed)
- Patient with History of Immunodeficiency HIV+,Hepatitis B virus ( HBV) and History of Life threatening allergic or immune -Mediated Reaction. the site of bone marrow aspiration potentially limiting Procedure.
- alcohol and drug abuse / dependence.
- Severe skin infection.
- Haemodynamically unstable.
- =subject with primary and secondary diabetes , Insulin dependence.
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 Stem CellAlso: Intrathecal transplantation of autologous MNCsIntrathecal transplantation of autologous 100 millions Stem cells{MNCs } per dose' | Biological | STEM CELL |
Primary outcome
Improvement in Cognitive and psychiatric symptoms
Time frame: 6 Months
4 secondary outcomes
Improvement in neuropsychiatric behaviour
Time frame: 6 Months
Increase in life expectancy
Time frame: 6 Months
Improvement in writhing motions or abnormal posturing
Time frame: 6 month
Improvement in compulsive behaviour
Time frame: 6 month
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, M.S 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 autologous Stem Cell in people with Huntington Disease, 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 7 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?
Improvement in Cognitive and psychiatric symptoms (time frame: 6 Months). 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.