Bone Marrow Collection in Healthy Volunteers (iCell) | NCT02118740

Studies
Bone Marrow Collection in Healthy Volunteers (iCell)

NCT02118740

Sponsor

Amarna Stem Cells BV

Status

Unknown status

Last Update Posted

Jan 30, 2017Estimated

Enrollment

15Estimated

Phase

Not provided

Conditions

Spinal Cord Injury

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
A2013SCI-01	Other Identifier	Sponsor Identification number

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Dec 30, 2017Estimated

Completion Date

Apr 30, 2018Estimated

First Submitted Date

Mar 18, 2014

First Submission Date that Met QC Criteria

Apr 17, 2014

First Posted Date

Apr 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2017

Last Update Posted Date

Jan 30, 2017Estimated

Name	Class
Neuroplast	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	3 days

Secondary Outcomes

Measure	Description	Time Frame
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).	3 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Young healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Johannes de Munter, MD	Contact	+31-615897008		h.demunter@neuroplast.com

Overall Officials

Name	Affiliation	Role
Harry Steinbusch, Prof.dr.	University Maastricht	Study Director
Gerard Bos, Prof.dr.	Maastricht University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MUMC	Recruiting	Maastricht	Limburg	6202 AZ	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The bone marrow characteristics shall be published as part of the preclinical studies and in particular as a request of the METC

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided