Bone Marrow Collection in Healthy Volunteers (iCell)
iCell
2 other identifiers
observational
15
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedJanuary 30, 2017
January 1, 2017
2.6 years
March 18, 2014
January 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of mononuclear cells include hematopoietic stem and progenitor cells in AMARCELL
Important is to have more than 2 million mononuclear cells (MNCs) include hematopoietic stem and progenitor cells in the end product AMARCELL
3 days
Secondary Outcomes (1)
Absence of contamination with infectious agents especially bacteria and pseudomonas
3 days
Eligibility Criteria
Young healthy volunteers
You may qualify if:
- 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
You may not qualify if:
- 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.
- Abuse of alcohol, medicines or illicit drugs.
- Legally protected people
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amarna Stem Cells BVlead
- Neuroplastcollaborator
Study Sites (1)
MUMC
Maastricht, Limburg, 6202 AZ, Netherlands
Biospecimen
A stem cell specimen will be retained to enable verification in the future
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Harry Steinbusch, Prof.dr.
University Maastricht
- PRINCIPAL INVESTIGATOR
Gerard Bos, Prof.dr.
Maastricht University Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Week
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2014
First Posted
April 21, 2014
Study Start
June 1, 2015
Primary Completion
December 30, 2017
Study Completion
April 30, 2018
Last Updated
January 30, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
The bone marrow characteristics shall be published as part of the preclinical studies and in particular as a request of the METC