Clinical Study to Evaluate the Safety and Efficacy BMMNC in Cerebellar Ataxia

September 16, 2014 updated by: Dr. Sachin Jamadar, Chaitanya Hospital, Pune

Clinical Study to Evaluate the Safety and Efficacy of Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Cerebellar Ataxia .It is Self Funded (Patients' Own Funding) Clinical Trial

Cerebellar ataxia is a complex motor disturbance, which, can occur as a result of many diseases and presents with symptoms of an inability to coordinate balance, gait, extremity and eye movements. Lesions to the cerebellum can cause dyssynergia, dysmetria, dysdiadochokinesia, dysarthria and ataxia of stance and gait. Deficits are observed with movements on the same side of the body as the lesion (ipsilaterally).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Pune,, Maharashtra, India, 411030
        • Recruiting
        • Chaitanya Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age limit: 18 -65
  • Diagnosed as Cerebellar ataxia
  • Willingness to undergo Bone marrow transplantation BMMNC.
  • To give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
  • willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion Criteria:

  • Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
  • Women who are pregnant or lactating
  • Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
  • Suffering from Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
  • Positive test results for HIV and AIDS complex ,HCV , HbsAg and Syphilis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: BMMNC
Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
Biological: Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell BMMNCs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE
Time Frame: baseline and after 12 month
To see improvement in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE when compare with baseline and after 12 month.
baseline and after 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance test
Time Frame: baseline and after 12 MONTH
To see improvement in Balance test when compare with baseline and after 12 month.
baseline and after 12 MONTH
Tremor Rating Scale
Time Frame: baseline and after 12 MONTH
compare the pre and post Tremor Rating Scale
baseline and after 12 MONTH
quality of life
Time Frame: baseline and 12 months
baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chaitanya Hospital, Pune

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (ESTIMATE)

October 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSCC/BMCA/2013//01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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