A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism. It is Self Funded (Patients' Own Funding) Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement in childhood autism rating scale
研究概览
简要总结
This clinical trial is a single Arm, single centre to check the safety and efficacy of bone marrow derived autologous mono nuclear cells (MNC) (100 million per dose). Trial to be conducted for 36 months.
详细描述
Autism is a developmental disorder that appears in the first 3 years of life, and affects the brain's normal development of social and communication skills. Autism is a physical condition linked to abnormal biology and chemistry in the brain. The exact causes of these abnormalities remain unknown,Symptoms-Children with autism typically have difficulties in: Pretend play, Social interactions, Verbal and non-verbal communication. Some children with autism appear normal before age 1 or 2 and then suddenly "regress" and lose language or social skills they had previously gained. This is called the regressive type of autism. People with autism may: Be overly sensitive in sight, hearing, touch, smell, or taste.
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
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient should suffer from Autism.
- •willingness to undergo bone marrow derived autologous cell therapy.
- •patient those provide fully Informed consent form for the study.
- •Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
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.History of Life threatening Allergic or immune- mediated reaction.
研究组 & 干预措施
STEM CELL
intra thecal injection of MNC stem cell therapy
干预措施: STEM CELL THERAPY (Biological)
结局指标
主要结局
Improvement in childhood autism rating scale
时间窗: 6 month
次要结局
- Improvement in perfusion of brain with PET scan report(6 MONTH)
研究者
Dr. Sachin Jamadar
CO-Investigator
Chaitanya Hospital, Pune