Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02118740
Recruitment Status : Unknown
Verified January 2017 by Amarna Stem Cells BV.
Recruitment status was:  Recruiting
First Posted : April 21, 2014
Last Update Posted : January 30, 2017
Sponsor:
Collaborator:
Neuroplast
Information provided by (Responsible Party):
Amarna Stem Cells BV

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.

Condition or disease
Spinal Cord Injury

Detailed Description:
Coded anonymized patient data

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 15 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Bone Marrow Collection in Healthy Volunteers
Study Start Date : June 2015
Estimated Primary Completion Date : December 30, 2017
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of mononuclear cells include hematopoietic stem and progenitor cells in AMARCELL [ Time Frame: 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 Outcome Measures :
  1. Absence of contamination with infectious agents especially bacteria and pseudomonas [ Time Frame: 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).


Biospecimen Retention:   Samples With DNA
A stem cell specimen will be retained to enable verification in the future


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young healthy volunteers
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118740


Contacts
Layout table for location contacts
Contact: Johannes de Munter, MD +31-615897008 h.demunter@neuroplast.com

Locations
Layout table for location information
Netherlands
MUMC Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Amarna Stem Cells BV
Neuroplast
Investigators
Layout table for investigator information
Study Director: Harry Steinbusch, Prof.dr. University Maastricht
Principal Investigator: Gerard Bos, Prof.dr. Maastricht University Medical Center

Additional Information:

Layout table for additonal information
Responsible Party: Amarna Stem Cells BV
ClinicalTrials.gov Identifier: NCT02118740     History of Changes
Other Study ID Numbers: NL44976.068.13
A2013SCI-01 ( Other Identifier: Sponsor Identification number )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The bone marrow characteristics shall be published as part of the preclinical studies and in particular as a request of the METC

Keywords provided by Amarna Stem Cells BV:
Autologous Stem Cells
Spinal Cord Injury
Preclinical

Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries