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

NCT01958177 | Unknown Phase 1

• 1 other identifier: CSCC/BMCA/2013//01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Cerebellar Ataxia

Keywords

stem cell; cerebellar ataxia; BMMNC

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Balance test

  baseline and after 12 MONTH

• Tremor Rating Scale

  baseline and after 12 MONTH

• quality of life

  baseline and 12 months

Study Arms (1)

BMMNC

OTHER

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)

Interventions

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

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

BMMNC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chaitanya Hospital, Pune: lead

Study Sites (1)

Chaitanya Hospital

Pune, Maharashtra, 411030, India

RECRUITING

MeSH Terms

Conditions

Cerebellar Ataxia

Condition Hierarchy (Ancestors)

Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ANANT E BAGUL, MS ORTHO

  Chaitanya Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sachin P Jamadar, D.Ortho

CONTACT

918888788880; sac2751982@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co -investigator

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: October 9, 2013
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

IN (1)