Bone Marrow Collection in Healthy Volunteers

Amarna Stem Cells BV1 site in 1 country15 target enrollmentJune 2015

ConditionsSpinal Cord Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Injury
Sponsor: Amarna Stem Cells BV
Enrollment: 15
Locations: 1
Primary Endpoint: Number of mononuclear cells include hematopoietic stem and progenitor cells in AMARCELL
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

April 30, 2018

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Amarna Stem Cells BV

Responsible Party

Sponsor

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