Bone Marrow Collection in Healthy Volunteers (iCell)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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Coded anonymized patient data

Conditions

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Spinal Cord Injury

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes