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

Primary Purpose

Huntington Disease

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
autologous Stem Cell
Sponsored by
Chaitanya Hospital, Pune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington Disease focused on measuring Huntington Disease,stem cell therapy

Eligibility Criteria

35 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chaitanya HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

STEM CELL

Arm Description

Transfer of autologous Stem cell( MNCs) intrathecally

Outcomes

Primary Outcome Measures

Improvement in Cognitive and psychiatric symptoms

Secondary Outcome Measures

Improvement in neuropsychiatric behaviour
Increase in life expectancy
Increase in life expectancy.Time period- 6 Months
Improvement in writhing motions or abnormal posturing
-Improvement in writhing motions or abnormal posturing
Improvement in compulsive behaviour

Full Information

First Posted
April 11, 2013
Last Updated
September 16, 2014
Sponsor
Chaitanya Hospital, Pune
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1. Study Identification

Unique Protocol Identification Number
NCT01834053
Brief Title
Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea.
Acronym
BMACHC
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chaitanya Hospital, Pune

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
Keywords
Huntington Disease,stem cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEM CELL
Arm Type
Other
Arm Description
Transfer of autologous Stem cell( MNCs) intrathecally
Intervention Type
Biological
Intervention Name(s)
autologous Stem Cell
Other Intervention Name(s)
Intrathecal transplantation of autologous MNCs
Intervention Description
Intrathecal transplantation of autologous 100 millions Stem cells{MNCs } per dose'
Primary Outcome Measure Information:
Title
Improvement in Cognitive and psychiatric symptoms
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Improvement in neuropsychiatric behaviour
Time Frame
6 Months
Title
Increase in life expectancy
Description
Increase in life expectancy.Time period- 6 Months
Time Frame
6 Months
Title
Improvement in writhing motions or abnormal posturing
Description
-Improvement in writhing motions or abnormal posturing
Time Frame
6 month
Title
Improvement in compulsive behaviour
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin P Jamadar, D Ortho
Phone
+918888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Smita S Bhoyar, B.A.M.S.PGCR
Phone
9372620569
Email
drsmitabhoyar@rediff.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, M.S
Organizational Affiliation
CHAITANYA HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaitanya Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411009
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin P Jamadar, D ORTHO
Phone
+918888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name & Degree
Smita S Bhoyar, B AMS PGCR
Phone
9372620569
Email
drsmitabhoyar@rediffmail.com
First Name & Middle Initial & Last Name & Degree
Anant E Bagul, MS

12. IPD Sharing Statement

Learn more about this trial

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

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