Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

Timing for Intracoronary Administration of Bone Marrow Mononuclear Cells After Acute ST-elevated Myocardial Infarction: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425358
• Other study ID #: 2004BA714B05-2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 15, 2015
• Last updated: April 23, 2015
• Start date: February 2005
• Est. completion date: August 2006

Study information

• Verified date: April 2015
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• 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.
• 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.
• 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.
• PCI only
The saline was intracoronary infusion with the use of microtubular.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University	Fudan University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of left ventricular eject factor (LVEF) from the baseline		12 months	Yes
Secondary	Change of left ventricular end-diastolic volume (LVESV) from the baseline		12 months	Yes
Secondary	Change of left ventricular end-systolic volume (LVEDV) from the baseline		12 months	Yes
Secondary	Change of myocardial perfusion from the baseline		12 months	Yes