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

This study is currently recruiting participants.
Verified April 2013 by Chaitanya Hospital, Pune
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier:
NCT01834053
First received: April 11, 2013
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Huntington Disease
Biological: autologous Stem Cell
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Bone Marrow Derived MNCs for the Treatment of Huntingtons Chorea.

Resource links provided by NLM:


Further study details as provided by Chaitanya Hospital, Pune:

Primary Outcome Measures:
  • Improvement in Cognitive and psychiatric symptoms [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in neuropsychiatric behaviour [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Increase in life expectancy [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Increase in life expectancy.Time period- 6 Months

  • Improvement in writhing motions or abnormal posturing [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    -Improvement in writhing motions or abnormal posturing

  • Improvement in compulsive behaviour [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
STEM CELL
Transfer of autologous Stem cell( MNCs) intrathecally
Biological: autologous Stem Cell
Intrathecal transplantation of autologous 100 millions Stem cells{MNCs } per dose'
Other Name: Intrathecal transplantation of autologous MNCs

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.

  Eligibility

Ages Eligible for Study:   35 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834053

Contacts
Contact: Sachin P Jamadar, D Ortho +918888788880 sac2751982@gmail.com
Contact: Smita S Bhoyar, B.A.M.S.PGCR 9372620569 drsmitabhoyar@rediff.com

Locations
India
Chaitanya Hospital Recruiting
Pune, Maharashtra, India, 411009
Contact: Sachin P Jamadar, D ORTHO    +918888788880    sac2751982@gmail.com   
Contact: Smita S Bhoyar, B AMS PGCR    9372620569    drsmitabhoyar@rediffmail.com   
Principal Investigator: Anant E Bagul, MS         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
Principal Investigator: ANANT E BAGUL, M.S CHAITANYA HOSPITAL
  More Information

No publications provided

Responsible Party: Dr. Sachin Jamadar, CO-Investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01834053     History of Changes
Other Study ID Numbers: 00106
Study First Received: April 11, 2013
Last Updated: April 15, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Chaitanya Hospital, Pune:
Huntington Disease,stem cell therapy

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014