Bone Marrow Derived Mononuclear Cells For Myocardial Rege... | NCT00938847

Studies
Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

NCT00938847

Sponsor

Asklepios proresearch

Status

Completed

Last Update Posted

Jul 14, 2009Estimated

Enrollment

20Actual

Phase

Phase 3

Conditions

Left Ventricular Dysfunction

Interventions

Countries

Germany

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

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jul 13, 2009

First Submission Date that Met QC Criteria

Jul 13, 2009

First Posted Date

Jul 14, 2009Estimated

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

Jul 13, 2009

Last Update Posted Date

Jul 14, 2009Estimated

Name	Class
Cordis US Corp.	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

Evaluative pilot study for safety and feasibility with administration of autologous bone bone marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo the ischemic lesion.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Name	Type	Description	Arm Group Labels	Other Names
PCI	Device	Stent implantation after acute myocardial infarction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Demonstration of safety and feasibility of BM-MNC treatment. Investigation of the suitability of endocardial left ventricular electromechanical mapping (LVEMM) with NOGA as endpoint for myocardial regeneration.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

LVEF <40%
PCI at latest 6 hours after infarction
BMI >20 kg/m² and <30 kg/m²

Exclusion Criteria:

PCI elder than 14 days
relevant valvular disease
left ventricular dysfunction caused by other reasons than ischemic cardiomyopathy
history of stroke, chronic atrial fibrillation, multivessel disease, thromboembolic event
scheduled for CABG
DM Type 1 & extensive hypercholesterinemia
pacemaker
systemic disease
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karl-Heinz Kuck, Prof. Dr. med.	Asklepios Klinik St. Georg, Departement of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asklepios Klinik St. Georg, Departement of Cardiology		Hamburg		20099	Germany

Condition Browse Module

MeSH Terms

ID	Term
D018487	Ventricular Dysfunction, Left
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D018754	Ventricular Dysfunction
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
2005-003629-19
2508