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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Chaitanya Hospital, Pune
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier:
NCT01958177
First received: July 31, 2013
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Cerebellar Ataxia
Biological: Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Chaitanya Hospital, Pune:

Primary Outcome Measures:
  • improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE [ Time Frame: baseline and after 12 month ] [ Designated as safety issue: Yes ]
    To see improvement in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE when compare with baseline and after 12 month.


Secondary Outcome Measures:
  • Balance test [ Time Frame: baseline and after 12 MONTH ] [ Designated as safety issue: Yes ]
    To see improvement in Balance test when compare with baseline and after 12 month.

  • Tremor Rating Scale [ Time Frame: baseline and after 12 MONTH ] [ Designated as safety issue: Yes ]
    compare the pre and post Tremor Rating Scale

  • quality of life [ Time Frame: baseline and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
BMMNC
Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958177

Contacts
Contact: Sachin P Jamadar, D.Ortho 918888788880 sac2751982@gmail.com

Locations
India
Chaitanya Hospital Recruiting
Pune,, Maharashtra, India, 411030
Contact: Sachin P Jamadar, D ORTHO    +918888788880    sac2751982@gmail.com   
Principal Investigator: Anant E Bagul, MS,Ortho         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
Principal Investigator: ANANT E BAGUL, MS ORTHO Chaitanya Hospital
  More Information

No publications provided

Responsible Party: Dr. Sachin Jamadar, Co -investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01958177     History of Changes
Other Study ID Numbers: CSCC/BMCA/2013//01
Study First Received: July 31, 2013
Last Updated: September 16, 2014
Health Authority: India: Institutional Review Board

Keywords provided by Chaitanya Hospital, Pune:
stem cell
cerebellar ataxia
BMMNC

Additional relevant MeSH terms:
Ataxia
Cerebellar Ataxia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014