Effect of Stem-Kine Food Supplement on Circulating Stem Cells
| ISRCTN | ISRCTN25688299 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25688299 |
| Secondary identifying numbers | 2009-02 |
- Submission date
- 08/02/2010
- Registration date
- 25/02/2010
- Last edited
- 16/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nina Mikirova
Scientific
Scientific
3100 North Hillside Avenue
Wichita
67219
United States of America
Study information
| Study design | Observational |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact below to request a patient information sheet. |
| Scientific title | Effect of Stem-Kine Food Supplement on Circulating Stem Cells: an observational trial |
| Study acronym | ESFSCSC |
| Study objectives | The food supplement Stem-Kine may cause a modulation of circulating stem cell numbers in healthy volunteers |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2009 |
| Completion date | 01/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 18 |
| Key inclusion criteria | 1. Healthy adults, ages 20-72 2. Signed informed consent |
| Key exclusion criteria | 1. Systemic immune-compromised state 2. Ongoing infection or disease conditions 3. Significant abnormalities in biochemistry or complete blood count panels |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 01/12/2009 |
Locations
Countries of recruitment
- United States of America
Study participating centre
3100 North Hillside Avenue
Wichita
67219
United States of America
67219
United States of America
Sponsor information
Medistem Inc (USA)
Industry
Industry
9255 Towne Centre Drive, Suite 450
San Diego
92122
United States of America
"ROR" |
https://ror.org/03andxb27 |
|---|
Funders
Funder type
Charity
Allan P Markin (Canada) - individual funder
No information available
The Aidan Foundation (USA)
No information available
The Center For The Improvement Of Human Functioning International (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
