NCT05699694

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sociedad Española de Medicina Regenerativa y Terapia Celular · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	StemRegen product	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.

Timeline

• Start date: 2023-01-05
• Primary completion: 2025-02-01
• Completion: 2025-10-15
• First posted: 2023-01-26
• Last updated: 2024-05-29

Locations

1 site across 1 country: Spain