An Open Labeled Clinical Study to Evaluate the Safety and Efficacy OF Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Retinitis Pigmentosa. It is Self Funded (Patients' Own Funding) Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- visual acuity
研究概览
简要总结
Retinitis pigmentosa is an eye disease in which there is damage to the retina. The retina is the layer of tissue at the back of the inner eye that converts light images to nerve signals and sends them to the brain.Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) is used for this condition .
详细描述
This study will involve about 8 visits over 1½ years .Each participant will be enrolled in study as per inclusion and exclusion criteria .Informed consent will be taken from subject before including in study. Subject will be underwent for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. The primary outcome for this study will be a visual acuity score after one year of stem cell therapy .
Follow-up visits will be required regularly to determine the effectiveness of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) in RP.
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 18-65
- •Diagnosis of retinitis pigmentosa
- •willingness to undergo Bone marrow and umbilical cord derived Mesenchymal stem cell transplantation.
- •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
- •Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
- •Women who are pregnant or lactating
- •Complications of diabetic retinopathy.
结局指标
主要结局
visual acuity
时间窗: 1 YEAR
Electronic Visual Acuity (EVA) technology
次要结局
未报告次要终点
研究者
Dr. Sachin Jamadar
Co -investigator
Chaitanya Hospital, Pune