NCT01834053

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

1.8 years

First QC Date

April 11, 2013

Last Update Submit

September 16, 2014

Conditions

Huntington Disease

Keywords

Huntington Disease,stem cell therapy

Outcome Measures

Primary Outcomes (1)

  • Improvement in Cognitive and psychiatric symptoms

    6 Months

Secondary Outcomes (4)

  • Improvement in neuropsychiatric behaviour

    6 Months

  • Increase in life expectancy

    6 Months

  • Improvement in writhing motions or abnormal posturing

    6 month

  • Improvement in compulsive behaviour

    6 month

Study Arms (1)

STEM CELL

OTHER

Transfer of autologous Stem cell( MNCs) intrathecally

Biological: autologous Stem Cell

Interventions

autologous Stem CellBIOLOGICAL

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

Also known as: Intrathecal transplantation of autologous MNCs
STEM CELL

Eligibility Criteria

Age35 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaitanya Hospital

Pune, Maharashtra, 411009, India

RECRUITING

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • ANANT E BAGUL, M.S

    CHAITANYA HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sachin P Jamadar, D Ortho

CONTACT

+918888788880sac2751982@gmail.com

Smita S Bhoyar, B.A.M.S.PGCR

CONTACT

9372620569drsmitabhoyar@rediff.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CO-Investigator

Study Record Dates

First Submitted

April 11, 2013

First Posted

April 17, 2013

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

IN(1)