Bone Marrow Collection in Healthy Volunteers (iCell)

Bone Marrow Collection in Healthy Volunteers

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02118740

Acronym

iCell

Enrollment

Registered

2014-04-21

Start date

2015-06-30

Completion date

2018-04-30

Last updated

2017-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

Autologous Stem Cells, Spinal Cord Injury, Preclinical

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 30 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Netherlands

Contacts

Primary ContactJohannes de Munter, MD

h.demunter@neuroplast.com+31-615897008

Outcome results