NCT01908400Unknown1 期
An Open Labeled Clinical Study to Evaluate the Safety and Efficacy of Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Patients With Mental Retardation. It is Self Funded (Patients' Own Funding) Clinical Trial
Chaitanya Hospital, Pune1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Binet-Kamat Test
研究概览
简要总结
Mental retardation is a condition diagnosed before age 18 that includes below-average general intellectual function, and a lack of the skills necessary for daily living. Mental retardation affects about 1 - 3% of the population. There are many causes of mental retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells are used in this condition to prove its safety and efficacy .
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
- 5 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age limit: 5 -50
- •Primary diagnosis of mental retardation (IQ < 70)
- •willingness to undergo Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) transplantation.
- •To give an informed consent as well as sign the required Informed Consent Form (ICF)/video Consent 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
- •Advanced age that may produce deteriorating cognitive or motor functioning
- •Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer
- •Poor general health
研究组 & 干预措施
BMMNCs
Other
Intravenous transfer of (BMMNCs)
干预措施: Intravenous transfer of BMMNC (Biological)
结局指标
主要结局
Binet-Kamat Test
时间窗: 1 YEAR
CHANGE in IQ as measured by Binet-Kamat Test
次要结局
- Vineland Social Maturity Scale(baseline and 12 months)
研究者
Dr. Sachin Jamadar
Co -investigator
Chaitanya Hospital, Pune
研究点 (1)
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