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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Stemregen | Experimental | Experimental product encapsulated will be consumed orally with a glass of water. Six capsules per day will be consumed daily for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StemRegen product | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel G Garber, MD | Contact | 34 628766753 | mggarber@gmail.com | |
| Felix Pedrero, MD | Contact | 34 622411766 | consulta@doctorpedrero.com |
| Name | Affiliation | Role |
|---|---|---|
| Miguel G Garber, MD | Healthy Longevity Clinic | Principal Investigator |
| Felix Pedrero Ramallo, MD | Clinica Castello 68 | Study Chair |
| Christian Drapeou, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Castello 68 | Recruiting | Madrid | 28001 | Spain |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Single Group Assignment
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|
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 |
| Kalyagen |
| Study Director |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |