Bone Marrow Collection in Healthy Volunteers (iCell)

Spinal Cord Injury Clinical Trial

— iCell  

Official title:

Bone Marrow Collection in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02118740
• Other study ID #: NL44976.068.13
• Secondary ID: A2013SCI-01
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2014
• Last updated: January 27, 2017
• Start date: June 2015
• Est. completion date: April 30, 2018

Study information

• Verified date: January 2017
• Source: Amarna Stem Cells BV
• Contact: Johannes de Munter, MD
• Phone: +31-615897008
• Email: h.demunter[@]neuroplast.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Coded anonymized patient data

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 30, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
Netherlands	MUMC	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Amarna Stem Cells BV	Neuroplast BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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