|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01834053 |
|
Date of registration:
|
11/04/2013 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea.
BMACHC |
|
Scientific title:
|
Safety and Efficacy of Bone Marrow Derived MNCs for the Treatment of Huntingtons Chorea. It is Self Funded (Patients' Own Funding) Clinical Trial |
|
Date of first enrolment:
|
September 2014 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01834053 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Contacts
|
|
Name:
|
Sachin P Jamadar, D ORTHO |
|
Address:
|
|
|
Telephone:
|
+918888788880 |
|
Email:
|
sac2751982@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
ANANT E BAGUL, M.S |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHAITANYA HOSPITAL |
|
|
Name:
|
Sachin P Jamadar, D Ortho |
|
Address:
|
|
|
Telephone:
|
+918888788880 |
|
Email:
|
sac2751982@gmail.com |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Age minimum:
35 Years
Age maximum:
44 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Huntington Disease
|
|
Intervention(s)
|
|
Biological: autologous Stem Cell
|
|
Primary Outcome(s)
|
|
Improvement in Cognitive and psychiatric symptoms
[Time Frame: 6 Months]
|
|
Secondary Outcome(s)
|
|
Improvement in compulsive behaviour
[Time Frame: 6 month]
|
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|