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Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea.

Safety and Efficacy of Bone Marrow Derived MNCs for the Treatment of Huntingtons Chorea. It is Self Funded (Patients' Own Funding) Clinical Trial

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01834053
Acronym
BMACHC
Enrollment
50
Registered
2013-04-17
Start date
2014-09-30
Completion date
2016-06-30
Last updated
2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington Disease

Keywords

Huntington Disease,stem cell therapy

Brief 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 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.

Interventions

BIOLOGICALautologous Stem Cell

Intrathecal transplantation of autologous 100 millions Stem cells{MNCs } per dose'

Sponsors

Chaitanya Hospital, Pune
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 44 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Improvement in Cognitive and psychiatric symptoms6 Months

Secondary

MeasureTime frameDescription
Improvement in neuropsychiatric behaviour6 Months
Increase in life expectancy6 MonthsIncrease in life expectancy.Time period- 6 Months
Improvement in writhing motions or abnormal posturing6 month-Improvement in writhing motions or abnormal posturing
Improvement in compulsive behaviour6 month

Countries

India

Contacts

Primary ContactSachin P Jamadar, D Ortho
sac2751982@gmail.com+918888788880
Backup ContactSmita S Bhoyar, B.A.M.S.PGCR
drsmitabhoyar@rediff.com9372620569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026