NCT01454323

Brief Summary

Phase II clinical trial which will include all patients diagnosed with chronic anterior myocardial infarction (more than 6 months from the acute phase and the complete revascularization in which it is assessed the evolution of left ventricular function in patients to the monitoring against their own basal condition. Included patients will be studied in the following conditions:

  • Basal condition: defined as the immediately preceding to the administration of cell therapy treatment.
  • Monitoring Condition 1: three months after drug administration of cell therapy. Includes non-invasive methods of exploration of ventricular function.
  • Monitoring Condition 2: six months after administration of treatment. Includes the same methods of exploration of ventricular function practised in the basal condition, including cardiac catheterism as well as non invasive methods.
  • Monitoring Condition 3: twelve months after administration of the cell therapy drug. Includes non-invasive methods of exploration of ventricular function. The trial hypothesis we propose consists of mononuclear cells of bone marrow providing progenitor cells with regenerative capacity and also secreting several angiogenic factors, and their implantation into ischemic tissues should contribute with both elements to the angiogenesis and tissue regeneration with myocardial functional recovery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 30, 2015

Status Verified

November 1, 2014

Enrollment Period

4.2 years

First QC Date

October 12, 2011

Last Update Submit

June 29, 2015

Conditions

Chronic Myocardial Ischemia

Keywords

Chronic Myocardial IschemiaCell therapyBone marrow mononuclear cells

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in left ventricular ejection fraction (LVEF)

    3, 6 and 12 months after intervention

Secondary Outcomes (2)

  • Major Adverse Cardiac Events (MACE)

    12 months

  • Functional grade of the New York Heart Association (NYHA)

    3,6 and 12 months

Study Arms (1)

Intervention

EXPERIMENTAL

Dose of bone marrow mononuclear cells: 5-7 x 108 total cells

Other: Bone marrow mononuclear cells

Interventions

Bone marrow mononuclear cellsOTHER

Intracoronary infusion of autologous bone marrow-derived mononuclear cells

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 80 years.
  • Patients diagnosed with Chronic anterior myocardial infarction (more than 6 months from the acute episode) with symptoms and / or signs of heart failure.
  • Left ventricular ejection fraction (LVEF)\<45% and distensibility changes.
  • Complete revascularization performed at least 6 months before infusion cells.

You may not qualify if:

  • Patients in active waiting list for heart transplantation..
  • Treatable patients with resynchronization.
  • Patients over 80 years
  • Coexistence of other serious systemic diseases.
  • Active infection, HIV, Hepatitis B or Hepatitis C.
  • Patients with malignant or pre-malignant tumours.
  • Coexistence of any haematological disease.
  • Pregnant women, in breastfeeding period, or in childbearing potential age who are not using effective contraception.
  • Patients who are currently participating or have completed their participation in a clinical trial in a period of less than three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Reina Sofía

Córdoba, Spain, 14004, Spain

Location

Related Links

Study Officials

  • Jose Suarez de lezo, MD, PhD

    University Hospital Reina Sofía, Córdoba.

    STUDY CHAIR

  • Inmaculada Herrera, MD, PhD

    University Hospital Reina Sofía, Córdoba.

    STUDY CHAIR

  • Miguel Ángel Romero, MD

    University Hospital Reina Sofía, Córdoba.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2011

First Posted

October 19, 2011

Study Start

December 1, 2010

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 30, 2015

Record last verified: 2014-11

Locations

ES(1)