Clinical trial NCT05699694: Clinical Study on the Efficacy of Natural Stem Cell Mobilizers on Parkinson Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Sociedad Española de Medicina Regenerativa y Terapia Celular
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Parkinson's Disease (PD) symptoms: Change from Baseline
timeFrame: 6 months
measure: Quality of Life Assessed by the Parkinson's Disease
timeFrame: 6 Months
measure: Parkinson's Disease (PD) symptoms: Change
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clinica Castello 68
Study officials:
affiliation: Healthy Longevity Clinic
name: Miguel G Garber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica Castello 68
name: Felix Pedrero Ramallo, MD
role: STUDY_CHAIR
affiliation: Kalyagen
name: Christian Drapeou, PhD
role: STUDY_DIRECTOR
References: