Bone Marrow Collection in Healthy Volunteers (iCell)

• Conditions: Spinal Cord Injury

• Registration Number: NCT02118740
• Lead Sponsor: Amarna Stem Cells BV

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 Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Study Start: 2015-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30
• Primary Completion: 2017-12-30
• Study Completion: 2018-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of mononuclear cells include hematopoietic stem and progenitor cells in AMARCELL	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

Name	Time	Method
Absence of contamination with infectious agents especially bacteria and pseudomonas	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).

Trial Locations

Locations (1)

MUMC; 🇳🇱 Maastricht, Limburg, Netherlands