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

Study Overview
=================
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).

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

Conditions
-----------------
Cerebellar Ataxia

Intervention / Treatment
-----------------
* Biological: Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BMMNC<br>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)<br>* Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell BMMNCs)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and after 12 month | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stem cell, cerebellar ataxia, BMMNC