Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction

NCT ID: NCT02425358

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2006-08-31

Brief Summary

Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary intervention (PCI); however, the optimal timing is unknown. The present study assessed the therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).

Detailed Description

On the basis of experimental studies that bone marrow mononuclear cells (BMCs) transfer in the injured tissue can promote regional myocardial perfusion and improved cardiac function, several clinical trials have shown that intracoronary bone marrow mononuclear cell (BMC) transplantation in acute myocardial infarction (AMI) patients several days after myocardial reperfusion is safe and may enhance the improvement of left ventricular ejection fraction (LVEF). The timing of BMC administration, baseline LVEF, dosage of BMC and other factors has been linked to improvement in LVEF after BMC transplantation. In our previous work, we gave BMCs within 24 hours after emergency percutaneous coronary intervention (PCI) and found that it was safe and effective . In addition, there are another report about longer time from symptom onset to BMC infusion (2-4 weeks), which also appeared effective . The timing of intracoronary stem cell administration may have a critical effect on cell engraftment and may be responsible for the various biological and functional responses to therapy. However, few studies have directly addressed the optimal timing of cell injections. Therefore, in this prospective randomized study, BMCs were given at different times (within 24 hours, 3 to 7 days, or 7 to 30 days after reperfusion) to investigate whether the timing of therapy affects the therapeutic response of AMI patients.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BMC therapy within 24 hours

Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 24 hours after successful primary PCI.

Group Type: EXPERIMENTAL

BMC therapy within 24 hours

Intervention Type: OTHER

The BMCs were isolated by Ficoll density gradient centrifugation on Lymphocyte Separation Medium. BMCs were infused into IRA at the site of the previous occlusion. This was accomplished with the use of a microtubular. After positioning of the microtubular into the distal segment vessel of the stent position in the infarct-related artery, 15 milliliter of the whole cell suspension was slowly administered via microtubular. The usual time should be over 10min to prevent back-flow and to prolong cellular contact time for cellular migration into the tissue. Patients in BMC therapy group within 24 hours remained in the cath-lab until the entire procedure, including primary PCI and intracoronary BMC infusion, was completed.

BMC therapy within 3-7 days

Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 3-7days after successful primary PCI.

Group Type: EXPERIMENTAL

BMC therapy within 3-7 days

Intervention Type: OTHER

Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.

BMC therapy within 7-30 days

Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 7-30days after successful primary PCI.

Group Type: EXPERIMENTAL

BMC therapy within 7-30 days

Intervention Type: OTHER

Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.

PCI only

Patients with acute myocardial infarction who were performed successful primary PCI.

Group Type: ACTIVE_COMPARATOR

PCI only

Intervention Type: OTHER

The saline was intracoronary infusion with the use of microtubular.

Interventions

BMC therapy within 24 hours

The BMCs were isolated by Ficoll density gradient centrifugation on Lymphocyte Separation Medium. BMCs were infused into IRA at the site of the previous occlusion. This was accomplished with the use of a microtubular. After positioning of the microtubular into the distal segment vessel of the stent position in the infarct-related artery, 15 milliliter of the whole cell suspension was slowly administered via microtubular. The usual time should be over 10min to prevent back-flow and to prolong cellular contact time for cellular migration into the tissue. Patients in BMC therapy group within 24 hours remained in the cath-lab until the entire procedure, including primary PCI and intracoronary BMC infusion, was completed.

Intervention Type: OTHER

BMC therapy within 3-7 days

Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.

Intervention Type: OTHER

BMC therapy within 7-30 days

Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.

Intervention Type: OTHER

PCI only

The saline was intracoronary infusion with the use of microtubular.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• a history of first acute ST-elevation myocardial infarction
• treatment with successful PCI two to twelve hours after symptom onset
• LVEF less than 50% on angiography immediately after emergency PCI or rescue PCI

Exclusion Criteria

• previous Q-wave myocardial infarction
• cardiogenic shock
• severe coexisting conditions such as acute and chronic heart failure, malignant
• arrhythmia, renal failure and severe bleeding that interfered with the ability of the
• patient to comply with the protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Rchuang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Yao K, Huang R, Sun A, Qian J, Liu X, Ge L, Zhang Y, Zhang S, Niu Y, Wang Q, Zou Y, Ge J. Repeated autologous bone marrow mononuclear cell therapy in patients with large myocardial infarction. Eur J Heart Fail. 2009 Jul;11(7):691-8. doi: 10.1093/eurjhf/hfp062. Epub 2009 May 6.

Reference Type: BACKGROUND

PMID: 19420003 (View on PubMed)

Yao K, Huang R, Qian J, Cui J, Ge L, Li Y, Zhang F, Shi H, Huang D, Zhang S, Sun A, Zou Y, Ge J. Administration of intracoronary bone marrow mononuclear cells on chronic myocardial infarction improves diastolic function. Heart. 2008 Sep;94(9):1147-53. doi: 10.1136/hrt.2007.137919. Epub 2008 Apr 1.

Reference Type: BACKGROUND

PMID: 18381377 (View on PubMed)

Huang R, Yao K, Sun A, Qian J, Ge L, Zhang Y, Niu Y, Wang K, Zou Y, Ge J. Timing for intracoronary administration of bone marrow mononuclear cells after acute ST-elevation myocardial infarction: a pilot study. Stem Cell Res Ther. 2015 May 29;6(1):112. doi: 10.1186/s13287-015-0102-5.

Reference Type: DERIVED

PMID: 26021558 (View on PubMed)

Other Identifiers

2004BA714B05-2

Identifier Type: -

Identifier Source: org_study_id