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

Phase 1

• Conditions: Cerebellar Ataxia
• Interventions: Biological: Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)

• Registration Number: NCT01958177
• Lead Sponsor: Chaitanya Hospital, Pune

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-09
• Status Verified: 2014-09
• Study Start: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMMNC	Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)	Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)

Primary Outcome Measures

Name	Time	Method
improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE	baseline and after 12 month	To see improvement in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE when compare with baseline and after 12 month.

Secondary Outcome Measures

Name	Time	Method
Balance test	baseline and after 12 MONTH	To see improvement in Balance test when compare with baseline and after 12 month.
Tremor Rating Scale	baseline and after 12 MONTH	compare the pre and post Tremor Rating Scale
quality of life	baseline and 12 months

Trial Locations

Locations (1)

Chaitanya Hospital; 🇮🇳 Pune,, Maharashtra, India