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

Sociedad Española de Medicina Regenerativa y Terapia Celular

Status

Enrolling

Conditions

Parkinson Disease

Treatments

Dietary Supplement: StemRegen product

Study type

Interventional

Funder types

Other

Identifiers

NCT05699694

13246

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

21 to 90 years old

Volunteers

No Healthy Volunteers

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