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

NCT05699694 | Unknown DMC

• 1 other identifier: 13246
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Parkinson's Disease (PD) symptoms: Change from Baseline

  6 months

• Quality of Life Assessed by the Parkinson's Disease

  6 Months

• Parkinson's Disease (PD) symptoms: Change

  6 months

Study Arms (1)

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.

Dietary Supplement: StemRegen product

Interventions

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.

Experimental Stemregen

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sociedad Española de Medicina Regenerativa y Terapia Celular: lead

Study Sites (1)

Clinica Castello 68

Madrid, 28001, Spain

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Miguel G Garber, MD

  Healthy Longevity Clinic

  PRINCIPAL INVESTIGATOR

• Felix Pedrero Ramallo, MD

  Clinica Castello 68

  STUDY CHAIR

• Christian Drapeou, PhD

  Kalyagen

  STUDY DIRECTOR

Central Study Contacts

Miguel G Garber, MD

CONTACT

34 628766753; mggarber@gmail.com

Felix Pedrero, MD

CONTACT

34 622411766; consulta@doctorpedrero.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 26, 2023
• Study Start: January 5, 2023
• Primary Completion: February 1, 2025
• Study Completion: October 15, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-01

Locations

ES (1)