Clinical Study to Evaluate the Safety and Efficacy BMMNC in Cerebellar Ataxia
Primary Purpose
Cerebellar Ataxia
Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebellar Ataxia focused on measuring stem cell, cerebellar ataxia, BMMNC
Eligibility Criteria
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
Sites / Locations
- Chaitanya HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
BMMNC
Arm Description
Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
Outcomes
Primary Outcome Measures
improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE
To see improvement in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE when compare with baseline and after 12 month.
Secondary Outcome Measures
Balance test
To see improvement in Balance test when compare with baseline and after 12 month.
Tremor Rating Scale
compare the pre and post Tremor Rating Scale
quality of life
Full Information
NCT ID
NCT01958177
First Posted
July 31, 2013
Last Updated
September 16, 2014
Sponsor
Chaitanya Hospital, Pune
1. Study Identification
Unique Protocol Identification Number
NCT01958177
Brief Title
Clinical Study to Evaluate the Safety and Efficacy BMMNC in Cerebellar Ataxia
Official Title
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
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
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chaitanya Hospital, Pune
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Ataxia
Keywords
stem cell, cerebellar ataxia, BMMNC
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
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BMMNC
Arm Type
Other
Arm Description
Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
Intervention Type
Biological
Intervention Name(s)
Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
Intervention Description
Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell BMMNCs)
Primary Outcome Measure Information:
Title
improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE
Description
To see improvement in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE when compare with baseline and after 12 month.
Time Frame
baseline and after 12 month
Secondary Outcome Measure Information:
Title
Balance test
Description
To see improvement in Balance test when compare with baseline and after 12 month.
Time Frame
baseline and after 12 MONTH
Title
Tremor Rating Scale
Description
compare the pre and post Tremor Rating Scale
Time Frame
baseline and after 12 MONTH
Title
quality of life
Time Frame
baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin P Jamadar, D.Ortho
Phone
918888788880
Email
sac2751982@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, MS ORTHO
Organizational Affiliation
Chaitanya Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaitanya Hospital
City
Pune,
State/Province
Maharashtra
ZIP/Postal Code
411030
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
Anant E Bagul, MS,Ortho
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Evaluate the Safety and Efficacy BMMNC in Cerebellar Ataxia
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