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

Chaitanya Hospital, Pune

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cerebellar Ataxia

Treatments: Biological: Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)

Study type: Interventional

Funder types: Other

Identifiers

NCT01958177

CSCC/BMCA/2013//01

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

BMMNC

Other group

Description:

Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)

Treatment:

Biological: Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)