The Long-term and Short-term Efficacy and Safety of Trans... | NCT01748383

Studies
The Long-term and Short-term Efficacy and Safety of Transplantation Autologous Bone Marrow Cells (BMCs) in Patients With the First STEMI (ST Segment Elevation Myocardial Infarction)

NCT01748383

Sponsor

Russian Academy of Medical Sciences

Status

Unknown status

Last Update Posted

Dec 17, 2012Estimated

Enrollment

85Estimated

Phase

Phase 2

Conditions

Vascular Diseases
Cardiovascular Diseases
Acute Myocardial Infarction

Interventions

Transplantation of BMMCs
Transplantation of CD 133+ cells
stenting of IRA

Countries

Russia

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

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Sep 2013Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

Dec 7, 2012

First Submission Date that Met QC Criteria

Dec 11, 2012

First Posted Date

Dec 12, 2012Estimated

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

Dec 13, 2012

Last Update Posted Date

Dec 17, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vyacheslav Ryabov, Leading researcher of Emergency Cardiology Department, Russian Academy of Medical SciencesPrincipal Investigator

Lead Sponsor

Russian Academy of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to test the hypothesis that the intracoronary transplantation of autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular contractile function and will reduce the combined end points after the primary STEMI (mortality, recurrent myocardial infarction, angina, heart failure, stroke).

Detailed Description

The study was randomized, opened, controlled. 85 patients with the first STEMI were enrolled. Patients were divided to three groups. On admission all patients were received thrombolytic therapy by 1,5 million U streptokinase. Transplantation of autologous mononuclear bone marrow cells (BMMCs) and аutologous CD133 + cells by balloon catheter placed into infarct-related artery (IRA) was performed at once after stent implantation in 28 patients patients (1st group) and in 10 patients (2nd group) on the 7-21 days of STEMI. Another 47 patients (3nd group) undergo only stent implantation into IRA the same day of STEMI.

Autologous BMMCs were obtained from bone marrow aspirate by gradient centrifugation. Echocardiography, Holter monitoring were performed. Plasma concentration of the pro-inflammatory and anti-inflammatory cytokines (IL1, 6,8,10), of the growth factors (stem cell factor - SCF, vascular endothelial growth factor - VEGF, hepatocyte growth factor - HGF, fibroblast growth factor - FGF, insulin-like growth factor - IGF), the number of circulating CD34 +38-, CD133 +, СD117 +, CD90 +34- stem cells were determined in these patients in the acute and sub-acute myocardial infarction period.

It is going 7 years after the beginning of planned to evaluate left ventricular function of these patients, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, to evaluate the safety of transplantation of autologous BMCs (formation of intra-myocardial tumor or neoplastic processes of other sites) after 7 years from the beginning of study.

Conditions Module

Conditions

Vascular Diseases
Cardiovascular Diseases
Acute Myocardial Infarction

Keywords

Bone marrow cells
Acute myocardial infarction
Transplantation of autologous mononuclear
Transplantation of autologous CD133 + cells

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transplantation of BMMCs	Experimental	Autologous BMCs aspiration and transplantation of these cells	Procedure: Transplantation of BMMCs
Transplantation of CD 133+ cells	Experimental	Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells	Procedure: Transplantation of CD 133+ cells
stenting of IRA	Active Comparator	The only stenting of IRA	Procedure: stenting of IRA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transplantation of BMMCs	Procedure	The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. BMMCs were obtained by the method of the gradient centrifugation. Autologous BMMCs in the number 93±43 million transplantation by balloon catheter performed into IRA at once after stent implantation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left ventricular ejection fraction (Echo)		for an average of 7 years

Secondary Outcomes

Measure	Description	Time Frame
incidence of cardiovascular death		7 years
incidence of the recurrent myocardial infarction		7 years
incidence of the angina

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years and to 75 Years
Informed consent
First STEMI
Term admission to an intensive care unit in the first 24 hours of onset
Time reperfusion of the IRA is not earlier than 4 hours after the initial onset of acute transmural myocardial infarction

Exclusion Criteria:

Atrial fibrillation, a permanent form Valvular heart disease
Severe comorbidity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 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
Vyacheslav Ryabov, MD, PhD	Scientific and Research Institution of Cardiology of Siberian Department of RAMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scientific and Research Institution of Cardiology of Siberian Department of RAMS		Tomsk		634012	Russia

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Vyacheslav Ryabov, Leading researcher of Emergency Cardiology Department, Russian Academy of Medical Sciences

Unposted Events

Type	Date	Date Unknown
Release	Dec 10, 2016
Reset	Feb 2, 2017
Release	Mar 2, 2017

Violation Annotation

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

Estimated Results First Submitted Date

Dec 10, 2016

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 10, 2016			Feb 2, 2017
Mar 2, 2017			Apr 12, 2017
Apr 17, 2017			Jul 13, 2017

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases