Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2009-02
Study information
Scientific title
Effect of Stem-Kine Food Supplement on Circulating Stem Cells: an observational trial
Acronym
ESFSCSC
Study hypothesis
The food supplement Stem-Kine may cause a modulation of circulating stem cell numbers in healthy volunteers
Ethics approval
Institutional Review Board of The Center for Improvement of Human Health International, Wichita, Kansas, USA approved on the 29th of July 2009 (ref: 2009-02)
Study design
Observational
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use contact below to request a patient information sheet.
Condition
Healthy Volunteers
Intervention
Ingestion of the commercially-available food supplement Stem-Kine:
Two 8 ml blood draws in heparinized Vacutainer tubes are collected by venipuncture before administration of Stem-Kine supplementation (day 0) and at days 1, 2, 7, and 14. Study participants are required to ingest two capsules of Stem-Kine (700mg/capsule) in the morning and two in the evening for 14 days.
Comparison is made pre- and post- treatment all recruited subjects.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Alteration in circulating hematopoietic and endothelial progenitor cells.
Blood samples taken pre-supplementation (day 0), and at days 1, 2, 7, and 14 are analyzed by flow cytometry and colony forming assays
Secondary outcome measures
Changes in overall health/mood, based on self reporting
Overall trial start date
01/08/2009
Overall trial end date
01/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy adults, ages 20-72
2. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
18
Participant exclusion criteria
1. Systemic immune-compromised state
2. Ongoing infection or disease conditions
3. Significant abnormalities in biochemistry or complete blood count panels
Recruitment start date
01/08/2009
Recruitment end date
01/12/2009
Locations
Countries of recruitment
United States of America
Trial participating centre
3100 North Hillside Avenue
Wichita
67219
United States of America
Funders
Funder type
Charity
Funder name
Allan P Markin (Canada) - individual funder
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Aidan Foundation (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Center For The Improvement Of Human Functioning International (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary