Open-labeled Pilot Study on the Efficacy of a New Food Supplement Composed of Natural Stem Cell Mobilizers for the Improvement of Motor Performance and Quality of Life in Parkinsonian Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
Parkinson's disease is defined as the progressive loss or deterioration of dopaminergic neurons, Treatment approaches to maintain the normal dopamine level that include medication, surgery, cell therapy supplementation of L-Dihydroxyphenylalanine (L-Dopa), a precursor of dopamina, Stem cells from bone marrow can be mobilized according to the need of repair of the tissue. Suggested use of the food supplement actually sold in the USA and in Europe: Take two capsules, 1 to 3 times per day with a glass of water. Increase the Stem Cell circulating in the peripheral blood.
详细描述
Parkinson's disease is defined as the progressive loss or deterioration of dopaminergic neurons in Substantia Nigra (SN) of the brain. These cells normally produce dopamine which acts like a messenger for normal muscular movement. Having less quantity of dopamine in the synaptic cleft due to the loss of neural cells, symptoms become apparent. Neuroinflammation and oxidative stress are involved. Treatment approaches to maintain the normal dopamine level that include medication, surgery, cell therapy supplementation of L-Dihydroxyphenylalanine (L-Dopa), a precursor of dopamine, in the form of Levodopa and/or Carbidopa, has been available for PD therapy for 50 years. Stem cells constitute the repair system of the body. Stem cells from bone marrow can be mobilized according to the need of repair of the tissue. Suggested use of the food supplement actually sold in the USA and Europe: Take two capsules, 1 to 3 times per day with a glass of water.
All raw materials are food grade. All extracts are water or ethanolic extracts, which are authorized solvents for dietary supplements in the USA and EU. All ingredients are compliant with US and EU contaminants regulation (microbiological profile, heavy metals, pesticides) especially EU pharmacopeia, the product shows to increase Stem Cell circulation in peripheral blood.
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
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults from both genders
- •Diagnosed by neurologist or qualified health care practitioner with PD for 5 years or more
- •Stabilized symptomatic treatment for PD for more than 3 months
- •Age: over 21 years old
- •Volunteers able to understand the nature of the study and to sign a written consent form
排除标准
- •Gastro-intestinal surgery that may modify or decrease the intestinal absorption of nutrient and experimental product
- •Serious traumatism in the last 3 months
- •Heavy surgery operation in the last 3 months
- •Non-controlled evolutive disease
- •Drug or medication abuse in the last 2 years
- •History of non-compliance in previous studies
- •Regular consumption of similar ingredients or food supplements compared to experimental product in the past 3 months
- •Any medical problem or trouble identified by the investigator that could alter the capacity of the volunteer to end the study
- •Any drug medication that could mask, decrease or interfere experimental product efficacy
- •Surgery operation planned during the year
- •Breastfeeding, pregnant women
- •Known allergies to one of the ingredients entering in the composition of the experimental product
- •Severe liver and renal failure
- •Actual participation to another clinical trial
结局指标
主要结局
Adverse Events
时间窗: 6 months
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
- Parkinson's Disease (PD) symptoms: Change from Baseline(6 months)
- Parkinson's Disease (PD) symptoms: Change(6 months)
- Quality of Life Assessed by the Parkinson's Disease(6 Months)