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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
First Posted : April 21, 2014
Last Update Posted : January 30, 2017
Sponsor:
Collaborator:
Neuroplast
Information provided by (Responsible Party):
Amarna Stem Cells BV

Tracking Information
First Submitted Date March 18, 2014
First Posted Date April 21, 2014
Last Update Posted Date January 30, 2017
Study Start Date June 2015
Estimated Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2014)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02118740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 17, 2014)
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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bone Marrow Collection in Healthy Volunteers (iCell)
Official Title Bone Marrow Collection in Healthy Volunteers
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.
Detailed Description Coded anonymized patient data
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 1 Week
Biospecimen Retention:   Samples With DNA
Description:
A stem cell specimen will be retained to enable verification in the future
Sampling Method Non-Probability Sample
Study Population Young healthy volunteers
Condition Spinal Cord Injury
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 17, 2014)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2018
Estimated Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 30 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02118740
Other Study ID Numbers NL44976.068.13
A2013SCI-01 ( Other Identifier: Sponsor Identification number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: The bone marrow characteristics shall be published as part of the preclinical studies and in particular as a request of the METC
Responsible Party Amarna Stem Cells BV
Study Sponsor Amarna Stem Cells BV
Collaborators Neuroplast
Investigators
Study Director: Harry Steinbusch, Prof.dr. University Maastricht
Principal Investigator: Gerard Bos, Prof.dr. Maastricht University Medical Center
PRS Account Amarna Stem Cells BV
Verification Date January 2017