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

Cerebellar Ataxia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01958177
• Other study ID #: CSCC/BMCA/2013//01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 31, 2013
• Last updated: September 16, 2014
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2014
• Source: Chaitanya Hospital, Pune
• Contact: Sachin P Jamadar, D.Ortho
• Phone: 918888788880
• Email: sac2751982[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia

Intervention

Biological:
• Intravenous 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)

Locations

Country	Name	City	State
India	Chaitanya Hospital	Pune,	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Chaitanya Hospital, Pune

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Balance test	To see improvement in Balance test when compare with baseline and after 12 month.	baseline and after 12 MONTH	Yes
Secondary	Tremor Rating Scale	compare the pre and post Tremor Rating Scale	baseline and after 12 MONTH	Yes
Secondary	quality of life		baseline and 12 months	Yes