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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01958177

Enrollment

Registered

2013-10-09

Start date

2014-09-30

Completion date

2016-12-31

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebellar Ataxia

Keywords

stem cell, cerebellar ataxia, BMMNC

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).

Interventions

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

Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell BMMNCs)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

India

Contacts

Primary ContactSachin P Jamadar, D.Ortho

sac2751982@gmail.com918888788880

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026