NCT01958177Unknown1 期
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
Chaitanya Hospital, Pune2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE
时间窗: baseline and after 12 month
To see improvement in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE when compare with baseline and after 12 month.
次要结局
- Balance test(baseline and after 12 MONTH)
- Tremor Rating Scale(baseline and after 12 MONTH)
- quality of life(baseline and 12 months)
研究者
Dr. Sachin Jamadar
Co -investigator
Chaitanya Hospital, Pune
研究点 (2)
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