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

Chaitanya Hospital, Pune1 site in 1 country20 target enrollmentSeptember 2014

ConditionsCerebellar Ataxia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cerebellar Ataxia
Sponsor: Chaitanya Hospital, Pune
Enrollment: 20
Locations: 1
Primary Endpoint: improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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).

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

December 2016

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chaitanya Hospital, Pune

Responsible Party

Principal Investigator

Dr. Sachin Jamadar

Co -investigator

Chaitanya Hospital, Pune

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