Bone Marrow Collection in Healthy Volunteers (iCell) (iCell)

Bone Marrow Collection in Healthy Volunteers

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injury

Detailed Description

Coded anonymized patient data

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Johannes de Munter, MD; Phone Number: +31-615897008; Email: h.demunter@neuroplast.com

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6202 AZ
      • Recruiting
      • MUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Young healthy volunteers

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of contamination with infectious agents especially bacteria and pseudomonas	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).	3 days

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): December 30, 2017
• Study Completion (Anticipated): April 30, 2018

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: April 17, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Spinal Cord Injury; Autologous Stem Cells; Preclinical
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: NL44976.068.13; A2013SCI-01 (Other Identifier: Sponsor Identification number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The bone marrow characteristics shall be published as part of the preclinical studies and in particular as a request of the METC