Clinical Study on the Efficacy of Natural Stem Cell Mobilizers on Parkinson Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Dietary Supplement: StemRegen product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Stemregen<br>Experimental product encapsulated will be consumed orally with a glass of water. Six capsules per day will be consumed daily for 6 months. | Dietary Supplement: StemRegen product<br>* Products will be consumed orally in capsules with a glass of water. Six capsules per day will be consumed daily for 6 month. Two main administration schedules are possible: Two in the morning, 2 at noon, and 2 in the evening at each meal depending on individual habits of the volunteers to reduce non-compliance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson's Disease (PD) symptoms: Change from Baseline | UPDRS questionnaire which represents a validated and standardized questionnaire for PD diagnostic and disease progression evaluation: 0=normal - 4= Severe | 6 months | 
| Quality of Life Assessed by the Parkinson's Disease | Modified SF-36 quality of life assessment from Dr Gitte Jensen used in several clinical studies at NIS labs clinical center, Oregon USA, result from excellent to Terrible | 6 Months | 
| Parkinson's Disease (PD) symptoms: Change | Schwab and England activities of daily living activities scales from 0% to 100% | 6 months |