Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Optic Nerve Disease. It is Self Funded (Patients' Own Funding) Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Reduction in degeneration of the Optic nerve with improvement in vision
研究概览
简要总结
This is a Single arm, Single centre trial to check the safety and efficacy of bone marrow derived autologous mono nuclear cell(100 millions per dose )clinical trial to be conducted for 36 months in patients with optic nerve diseases.
详细描述
Optic Nerve Diseases: Conditions which produce injury or dysfunction of the second cranial or optic nerve, which is generally considered a component of the central nervous system. Damage to optic nerve fibres may occur at or near their origin in the retina, at the optic disk, or in the nerve, optic chiasm, optic tract, or lateral geniculate nuclei. Clinical manifestations may include decreased visual acuity and contrast sensitivity, impaired color vision, and an afferent papillary defect. primary out put of clinical study is to measures Improvement in visual loss and improvement in idiopathic intra cranial.This is a Single arm, Single centre trial to check the safety and efficacy of bone marrow derived autologous mono nuclear cell(100 millions per dose )clinical trial to be conducted for 36 months .
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Should suffer from Optic Nerve diseases Like Diabetic Retinopathy, retinal pigmentation
- •age in between 18 to 50
- •Willingness to undergo Bone Marrow derived autologous cell therapy.
- •Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the require Informed consent form(ICF) for the study.
- •A ability and willingness to regular visit to hospital for protocol and follow up.
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 laboratory Investigation that could cause a neurological defect including Syphilis, clinically relevant polyneuropathy) etc.
- •History of Life threatening Allergic or immune- mediated reaction
- •Haemodynamically Unstable.
结局指标
主要结局
Reduction in degeneration of the Optic nerve with improvement in vision
时间窗: 6 Months
次要结局
- Increase in Visual Function(6 months)
- Improvement in idiopathic intra cranial hypertension(6 Months)
研究者
Dr. Sachin Jamadar
CO-Investigator
Chaitanya Hospital, Pune