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

NCT ID: NCT05699694

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2025-10-15

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Stemregen

Experimental product encapsulated will be consumed orally with a glass of water. Six capsules per day will be consumed daily for 6 months.

Group Type: EXPERIMENTAL

StemRegen product

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Española de Medicina Regenerativa y Terapia Celular

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel G Garber, MD

Role: PRINCIPAL_INVESTIGATOR

Healthy Longevity Clinic

Felix Pedrero Ramallo, MD

Role: STUDY_CHAIR

Clinica Castello 68

Christian Drapeou, PhD

Role: STUDY_DIRECTOR

Kalyagen

Locations

Clinica Castello 68

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Miguel G Garber, MD

Role: CONTACT

mggarber@gmail.com

34 628766753

Felix Pedrero, MD

Role: CONTACT

consulta@doctorpedrero.com

34 622411766

Facility Contacts

Miguel G Garber, MD

Role: primary

mggarber@gmail.com

628766753

Adriana Ruiz Castro

Role: backup

larc32@hotmail.com

626554939

Other Identifiers

13246

Identifier Type: -

Identifier Source: org_study_id