Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction

Coronary Artery Disease Clinical Trial

— AMR-1  

Official title:

AMORCYTE MYOCARDIAL REPAIR STUDY- A Phase I Trial of Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction. (AMRS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313339
• Other study ID #: 0076-2006
• Secondary ID: FDA IND 12584
• Status: Completed
• Phase: Phase 1
• First received: April 10, 2006
• Last updated: November 15, 2013
• Start date: March 2006
• Est. completion date: March 2013

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Following a Heart attack the acute loss of heart muscle cells results in a cascade of events causing an immediate decrease in cardiac function that has the potential to persist long term. Despite revascularization of the infarct related artery circulation and appropriate medical management to minimize the stresses on the heart walls, a significant percentage of patients experience permanent cardiac dysfunction and consequently remain at an increased life-time risk of experiencing adverse cardiac events, including death.

There is a great potential for stem cell therapy, using a variety of cell precursors (particularly hematopoietic,)to contribute to new blood vessel formation (and possibly limited heart muscle formation) and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies.

Therefore, we propose to evaluate the safety and efficacy of a CD34+ selected stem cell product (AMR-001), administered through the infarct related coronary artery 6 to 9 days after successful infarct related artery stent placement.

The primary objective of the study is to determine the feasibility and safety of prospectively identifying patients at risk for clinically significant cardiac dysfunction following a myocardial infarction and the ability to isolate and infuse via the affected coronary circulation an autologous bone marrow derived CD34+ cell product at four dose levels.

The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent patient group meeting eligibility but not receiving CD34+ cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function without CD34+cell infusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2013
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18 - 75 years.

• Acute ST elevation myocardial infarction meeting ACC/AHA criteria, with symptoms of chest pain within 3 days of admission. Criteria include (ST elevation > 1mm in limb leads or 2 mm in two or more precordial leads and increased levels of troponin, CPK MB or both)

• NYHA heart failure class of I, II or III

Exclusion Criteria:

• Patients who are not candidates for percutaneous intervention, conscious sedation, MRI, SPECT imaging or mini-bone marrow harvest

• History of sustained chest pain unrelieved by nitrates, occurring 4 or more days before revascularization.

• Patients who fail to re-perfuse the infarct related coronary artery or have successful stent placement

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Drug:
• Intra-coronary infusion
In our study there will be four dosing cohorts (5, 10, 20 and 30 x 106) of CD34+ cells.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Texas Heart Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

Murrow J, Esteves F, Galt J, Chen J, Garcia E, Lin J, Lerakis S, Sher S, Khan Pohlel F, Waller EK, Vaughan D, Perin E, Willerson J, Kereiakes D, Preti R, Pecora AL, Quyyumi AA. Characterization of mechanical dyssynchrony measured by gated single photon em — View Citation

Quyyumi AA, Waller EK, Murrow J, Esteves F, Galt J, Oshinski J, Lerakis S, Sher S, Vaughan D, Perin E, Willerson J, Kereiakes D, Gersh BJ, Gregory D, Werner A, Moss T, Chan WS, Preti R, Pecora AL. CD34(+) cell infusion after ST elevation myocardial infarction is associated with improved perfusion and is dose dependent. Am Heart J. 2011 Jan;161(1):98-105. doi: 10.1016/j.ahj.2010.09.025. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac function at 3 and 6 months follow-up will be compared to baseline measures obtained the day(s) before CD34+ cell product infusion.		3 & 6 Months	No
Secondary	Perfusion of the infarct region at 6 months follow-up will be compared to baseline measures obtained the day(s) before CD34+ cell product infusion		6 Months	No
Secondary	An assessment will be performed to determine if a correlation exist between clinical outcome and cell content (CD34+) and/or in vitro colony growth (CFU-GM, CFU-GEMM, BFU-E) CXCR-4 mobility and CXCR-4 and/or VEGF surface antigen expression.		Baseline	No