Authors' recommendations: Cardiac remodelling as a result of AMI continues to be a debilitating process that leads to heart failure. Current medical treatments are inadequate and are only capable of slowing progression without addressing the underlying cause of the disease, which is the damage to cardiomyocytes and the vasculature sustained during MI and the progressive loss of cardiomyocytes in the failing heart. Stem cell therapy offers the potential to regenerate the myocardium and therefore reverse cardiac remodelling.The studies included for assessment in this report investigated the impact of bone marrow cell transplantation on recovery of myocardial infarction and heart failure resulting from myocardial infarction. Additionally the results were separated into those studies in which cells were transplanted via intracoronary infusion or intracoronary injection.In general, the studies which investigated the effect of bone marrow cell transplant via intracoronary infusion demonstrated positive effects in a variety of cardiac function indicators. Although not all studies demonstrated the same beneficial effects across all measured variables in general both global and regional cardiac function improved. The studies included did however present some shortcomings; most obvious is the short periods to which patients were followed up. Most studies only conducted follow-ups up until the three, four or six month follow-up. Additionally even during these follow-up periods high attrition rates were observed. Larger studies with longer follow-up periods and greater patient numbers (preferably multicentric randomised controlled trials) are required to establish the long term effects of this potentially revolutionary treatment.Studies which investigated intracoronary injection of bone marrow cells did not present as clear an indication of efficacy as did studies which infused cells. Much less evidence was available in terms of numbers of studies for intracoronary injection of these cells. Conflicting results from two studies were observed where the most notable difference appears to be the time at which patients were injected. Again further larger long term studies are required to reveal the true extent of benefit from the intracoronary injection delivery method.Therefore it appears as if the method of cell delivery may be associated with different levels of efficacy. The current evidence suggests intracoronary infusion of cells may be the best method for cell delivery. However this will need to be verified by further studies.In terms of safety, the procedure of harvesting and transplanting bone marrow cells (whether it is infusion or injection) tended to be safe in the vast majority of patients. Reports of death or serious adverse events were rare, indicating that at least for the short term this type of therapy is relatively safe. However, serious long term adverse events cannot be excluded and studies with long follow-up periods should be conducted to determine any unforseen long term effects of this therapy. In particular the possibility of tumour formation from possible chromosomal mutation, deregulated angiogenesis or myogenesis should be investigated. In saying this however, one must consider that for patients who have suffered MI development of heart failure can have serious if not fatal consequences.Although not covered in substantial detail in any of the studies retrieved, the composition of the cell suspension infused or injected, as well as their numbers may well impact on the extent of benefit conferred by bone marrow cells. While most studies mentioned the total numbers of cells transplanted and others also reported the composition, there is a need for investigation into whether the composition and quantity of the bone marrow cells transplanted plays a significant role in determining any benefits to the patient. More specifically, the question of whether a particular cell type or a specific combination of cell types confers the optimal benefit to the patient should be investigated. Currently, neither the optimal cell dosage nor the optimal cell type combination is known.While clinical improvements have been observed in the studies presented, autologous bone marrow cell transplantation must overcome the hurdle of showing long term clinical improvement. Should long term safety and efficacy be demonstrated, potential impacts include reduced hospitalisation (which may lead to reduced costs) and longer survival times (which could potentially lead to increased costs) for patients.

Project Status: Completed

URL for project: http://www.horizonscanning.gov.au/internet/horizon/publishing.nsf/Content/211ABF81A69CA39DCA2575AD0080F3DC/$File/HORIZON%20SCANNING%20REPORT-%20Autologous%20BMC%20for%20MI%20HF.pdf

Year Published: 2007

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Australian Safety and Efficacy Register of New Interventional Procedures-Surgical

Contact Address: ASERNIP-S 24 King William Street, Kent Town SA 5067 Australia Tel: +61 8 8219 0900

Contact Name: racs.asernip@surgeons.org

Contact Email: racs.asernip@surgeons.org

Copyright: Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S)