Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/02/2010
Date assigned
25/02/2010
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nina Mikirova

ORCID ID

Contact details

3100 North Hillside Avenue
Wichita
67219
United States of America

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

Sponsor information

Organisation

Medistem Inc (USA)

Sponsor details

9255 Towne Centre Drive
Suite 450
San Diego
92122
United States of America

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes