Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction

NCT02425358 | Completed Phase 2

• 1 other identifier: 2004BA714B05-2
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Myocardial Infarction

Keywords

cell therapy; BMC; timing

Outcome Measures

Primary Outcomes (1)

• Change of left ventricular eject factor (LVEF) from the baseline

  12 months

Secondary Outcomes (3)

• Change of left ventricular end-diastolic volume (LVESV) from the baseline

  12 months

• Change of left ventricular end-systolic volume (LVEDV) from the baseline

  12 months

• Change of myocardial perfusion from the baseline

  12 months

Study Arms (4)

BMC therapy within 24 hours

EXPERIMENTAL

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

Other: BMC therapy within 24 hours

BMC therapy within 3-7 days

EXPERIMENTAL

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

Other: BMC therapy within 3-7 days

BMC therapy within 7-30 days

EXPERIMENTAL

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

Other: BMC therapy within 7-30 days

PCI only

ACTIVE COMPARATOR

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

Other: PCI only

Interventions

BMC therapy within 24 hours 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 24 hours

BMC therapy within 3-7 days 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 3-7 days

BMC therapy within 7-30 days 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

PCI only OTHER

The saline was intracoronary infusion with the use of microtubular.

PCI only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead
• Fudan University: collaborator

Related Publications (3)

• 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.

  PMID: 19420003 BACKGROUND

• 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.

  PMID: 18381377 BACKGROUND

• 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.

  PMID: 26021558 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 24, 2015
• Study Start: February 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: April 24, 2015

Record last verified: 2015-04