Bone Marrow Collection in Healthy Volunteers (iCell) (iCell)
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ClinicalTrials.gov Identifier: NCT02118740
Recruitment Status : Unknown
Verified January 2017 by Amarna Stem Cells BV. Recruitment status was: Recruiting
This is a observational study in which healthy found volunteers are recruited to donate 50 ml of bone marrow aspirate to enable preclinical studies to obtain proof of concept and safety of a bone marrow derived stem cell preparation named AMARCELL. The prepared AMARCELL is only for animal studies and after completion of the preclinical program, the intention of AMARCELL is to treat humans with a traumatic Spinal cord injury.
Number of mononuclear cells include hematopoietic stem and progenitor cells in AMARCELL [ Time Frame: 3 days ]
Important is to have more than 2 million mononuclear cells (MNCs) include hematopoietic stem and progenitor cells in the end product AMARCELL
Secondary Outcome Measures :
Absence of contamination with infectious agents especially bacteria and pseudomonas [ Time Frame: 3 days ]
The end product has to be sterile and will be tested for contamination. No culture after plating on growth medium (after 14 days) and no foreign non-human particles in the sample using Polymerase Chain Reaction techniques (after 6 hours).
Biospecimen Retention: Samples With DNA
A stem cell specimen will be retained to enable verification in the future
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Layout table for eligibility information
Ages Eligible for Study:
20 Years to 30 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Young healthy volunteers
Men in the age range of 21-30 years and/or women in the age range of 21-30 years and taking birth control medication to prevent pregnancy
Written informed consent
Healthy as concluded by the answers given to questions in a short health questionnaire
Pregnancy or lactation period
Volunteers who are unable to comply with the rules of this project. Important is if the volunteer can not follow the schedule of the appointments.