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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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

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Huntington Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STEM CELL

Transfer of autologous Stem cell( MNCs) intrathecally

Group Type OTHER

autologous Stem Cell

Intervention Type BIOLOGICAL

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

Interventions

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autologous Stem Cell

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Intrathecal transplantation of autologous MNCs

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes