Spinal Cord InjuryiCellNCT02118740
Bone Marrow Collection in Healthy Volunteers (iCell)
An observational study of Spinal Cord Injury, run by Amarna Stem Cells BV at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to 30 Apr 2018
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
MUMC
Maastricht, Limburg, 6202 AZ
About this study
Official title: Bone Marrow Collection in Healthy Volunteers
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.
Read the detailed description
Coded anonymized patient data
- Conditions
- Spinal Cord Injury
- Keywords
- Autologous Stem Cells, Spinal Cord Injury, Preclinical
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Secondary outcomes (1)
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).
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJun 2015
- Primary completion30 Dec 2017 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Amarna Stem Cells BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neuroplast
- Responsible party
- Sponsor
- Investigators
- Harry Steinbusch, Prof.dr., Study director, University MaastrichtGerard Bos, Prof.dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118740
- Sponsor's protocol ID
- NL44976.068.13
- Other IDs
- A2013SCI-01
- Acronym
- iCell
- Status last verified
- Jan 2017
- First submitted
- 18 Mar 2014
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The bone marrow characteristics shall be published as part of the preclinical studies and in particular as a request of the METC
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Collection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02118740
- Acronym / sponsor ID
- iCell / NL44976.068.13
- Conditions
- Spinal Cord Injury
- Keywords
- Autologous Stem Cells, Spinal Cord Injury, Preclinical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Amarna Stem Cells BVIndustry (pharma, biotech, devices)
- Collaborators
- Neuroplast
- Study start
- Jun 2015
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young healthy volunteers
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Absence of contamination with infectious agents especially bacteria and pseudomonas
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Individual participant dataSharing planned: Yes. The bone marrow characteristics shall be published as part of the preclinical studies and in particular as a request of the METC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Steinbusch, Prof.dr. study director
University Maastricht
Gerard Bos, Prof.dr. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Amarna Stem Cells BV at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes de Munter, MD (+31-615897008, h.demunter@neuroplast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of mononuclear cells include hematopoietic stem and progenitor cells in AMARCELL (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.