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ISRCTN
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ISRCTN25688299
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ClinicalTrials.gov identifier
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Public title
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Effect of Stem-Kine Food Supplement on Circulating Stem Cells
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Scientific title
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Effect of Stem-Kine Food Supplement on Circulating Stem Cells: an observational trial
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Acronym
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ESFSCSC
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Serial number at source
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2009-02
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Study hypothesis
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The food supplement Stem-Kine may cause a modulation of circulating stem cell numbers in healthy volunteers
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Lay summary
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Not provided at time of registration
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Ethics approval
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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)
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Study design
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Observational
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Healthy Volunteers
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Participants - inclusion criteria
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1. Healthy adults, ages 20-72
2. Signed informed consent
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Participants - exclusion criteria
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1. Systemic immune-compromised state
2. Ongoing infection or disease conditions
3. Significant abnormalities in biochemistry or complete blood count panels
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Anticipated start date
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01/08/2009
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Anticipated end date
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01/12/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact below to request a patient information sheet.
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Target number of participants
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18
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Changes in overall health/mood, based on self reporting
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Sources of funding
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1. Allan P Markin (Canada) - individual funder
2. The Aidan Foundation (USA)
3. The Center For The Improvement Of Human Functioning International (USA)
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Trial website
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Publications
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Contact name
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Dr
Nina
Mikirova
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Address
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3100 North Hillside Avenue
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City/town
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Wichita
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Zip/Postcode
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67219
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Country
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United States of America
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Sponsor
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Medistem Inc (USA)
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Address
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9255 Towne Centre Drive, Suite 450
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City/town
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San Diego
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Zip/Postcode
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92122
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Country
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United States of America
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Date applied
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08/02/2010
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Last edited
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16/08/2011
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Date ISRCTN assigned
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25/02/2010
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