Stem Cell Therapy: Helping the Body Heal Itself
Stem cells are nature’s own transformers. When the body is injured, stem cells travel the scene of the accident. There, they help heal damaged tissue. They do this by transforming themselves into whatever type of cell has been injured. Stem cells can become bone, skin – even heart tissue. When your heart muscle is damaged in a heart attack, stem cells are summoned from the bone marrow to make repairs. Stem cells do a good job. But they could do better – for some reason, the heart stops signaling for heart cells after only a week or so after the damage has occurred, leaving the repair job mostly undone. The partially repaired tissue becomes a burden to the heart, forcing it to work harder and less efficiently, leading to heart failure.
Researchers believe that we can we can boost the efficiency of stem cells and help the body recover faster and better from heart attacks, even after the heart has stopped signaling for them. They’ve developed methods to enhance the body’s natural repair function, both in the setting of heart attack and congestive heart failure. Now these methods are being tested in clinical trials. Some of them are enrolling patients now. If you’re interested, read about some of these clinical trials below.
Clinical trials using stems cells to heal the heart:
ATHERSYS MULTISTEM: Following an acute myocardial infarction (AMI), the body automatically recruits stem cells from the bone marrow to repair damaged heart tissue. The problem, however, is the molecular signals that recruit the new stem cells stay on for only a short period. Consequently, damage to the myocardium is never repaired, which weakens its functionality and leads to chronic heart failure.
Cleveland Clinic also enrolled the first AMI patient who was treated with a multipotent adult progenitor cell developed by Cleveland-based biotech firm Athersys Inc. The first cohort of the Phase I clinical trial thus far suggests the Athersys MultiStem cell was administered safely and was well tolerated by the patients. This Phase I trial is continuing to recruit patients.
In preclinical AMI models, MultiStem has shown the potential to improve heart function. The MultiStem cells are derived from bone marrow of qualified donors.
“MultiStem is being developed as an off-the-shelf product so that it can be administered in the catheterization lab at any hospital while the patient is undergoing a stent procedure to open the artery,” says Marc S. Penn, MD, PhD, Department of Stem Cell Biology and Regenerative Medicine and the Robert and Suzanne Tomsich Department of Cardiovascular Medicine. “A Cricket Micro-Infusion Catheter, a proprietary device developed by Mercator Med Systems, enables physicians to rapidly and efficiently deliver the MultiStem cells in to the damaged region of the heart.”
Cleveland Clinic’s Department of Stem Cell Biology and Regenerative Medicine also is a key clinical site for national stem cell trials currently recruiting patients including trials being run by the National Institutes of Health Cardiovascular Cell Therapy Research Network. They include:
IMPACT-DCM: Led at Cleveland Clinic by Nicholas Smedira, MD, Cardiothoracic Surgery, this Phase II trial will examine intramyocardial delivery of autologous bone marrow cells in ischemic and non-ischemic patients with chronic heart failure due to dilated cardiomyopathy (DCM). Patients randomized into the treatment group of the IMPACT-DCM trial are treated with Cardiac Repair Cells (CRCs), an autologous, mixed-cell product (Aastrom Biosciences) containing expanded populations of stem and early progenitor cells produced from a small sample of the patient’s own bone marrow. The CRCs are injected into the heart muscle through minimally invasive surgery. The IMPACT-DCM trial will determine the safety and tolerability of CRCs compared to standard-of-care in patients with DCM.
MARVEL: This Phase II/III trial will assess safety and efficacy of MyoCell (Bioheart) autologous clinical cell therapy into myocardium post myocardial infarction to determine if adult stem cells can improve heart function. After autologous myoblasts are harvested from a patient’s skeletal muscle tissue, they are isolated and expanded in culture in a closed system. When a sufficient number of cells are estimated, they are taken from culture, packaged in a suspension and injected directly into the myocardium via the femoral artery.
TIME: The trial, led by site PI Stephen G. Ellis, MD, Cardiovascular Medicine, will provide stem cell infusions to patients three days or seven days after they receive percutaneous coronary intervention (PCI) for AMI. The study will evaluate the safety and effectiveness of placing bone marrow derived stem cells into the myocardium to improve its function following an AMI after successful revascularization. What’s more, the study will help determine the best time to deliver the stem cells after MI.
Late TIME: Also led by Dr. Ellis, this trial is similar to the TIME study. The only difference is that patients will receive their own bone marrow derived stem cells two to three weeks following AMI and PCI. For some patients, delaying the delivery of stem cells two to three weeks after AMI may be better than initiating treatment during the acute phase.
FOCUS: This trial will assess the effectiveness of bone marrow derived stem cell treatment for adults with chronic heart failure due to a history of myocardial infarction. Some patients with this condition, especially those with substantial scar tissue on the myocardium’s wall, or patients with a particular heart structure, may not be eligible to receive standard treatments of coronary artery bypass grafting or coronary angioplasty and stent placement. The trial, led by Dr. Ellis, will evaluate whether bone marrow derived stem cells may be an effective way to achieve therapeutic angiogenesis and improvement in heart function.
Coming Soon in 2010:
In January 2010, Dr. Penn expects to launch a new Phase I clinical trial to determine the safety and efficacy of stromal derived factor-1 (SDF-1) proprietary technology developed by Cleveland Clinic. In preclinical studies, animals that were injected with genes that express SDF-1 protein showed definite improvement in cardiac function over those animals that were given control genes.
Dr. Penn says the goal of this new gene therapy is to stimulate the recruitment of the patient’s own stem cells to repair the damaged heart tissue and to induce angiogenesis (new blood vessel growth). This trial is rather unique because most research involves harvesting stem cells from patients and delivering them directly into the heart via minimally invasive procedures and specially designed catheters.
Dr. Ellis, Dr. Penn, Dr. Smedira and their colleagues in the Heart & Vascular Institute are working hard to bring these developing stem cell therapies to the patient's bedside in a safe and timely fashion.
Important information about stem cell trials:
- All stem cell studies have strict protocols, approved by the FDA and the Cleveland Clinic Institutional Review Board for inclusion and exclusion criteria. To insure you meet the criteria, patients need to be evaluated by a physician and may require specific testing at the Cleveland Clinic. This testing may take more than one day to complete if you require studies or consultations with multiple physicians.
- Stem cell trials are randomized controlled studies – not all patients who undergo evaluation for stem cell trials will receive stem cell therapy.
- Each study has different protocols and the stem cells are accessed and administered differently, and have different criteria for follow-up. The research team will discuss all aspects of the trial with you in detail prior to signing consent and participating in the trial.
- Patients are not given monetary compensation for testing to determine enrollment into the different studies. Once a patient meets the screening baseline criteria and informed consent has been reviewed and signed, patients are not charged for any therapy or monitoring that is directly related to the research. Travel, lodging and meals are not covered by the studies.
Cleveland Clinic is a large referral center for advanced heart disease and heart failure – we offer a wide range of therapies – including medications, devices and surgery. Patients will be evaluated for the treatments that best address their condition. Whether patients meet the criteria for stem cell therapy – or not, they will be offered the most advanced array of treatment options.
If you need more information
If you need more information about stem cell therapy or would like to make an appointment with a specialist, contact us, chat online with a nurse or call the Miller Family Heart and Vascular Institute Resource & Information Nurse at 216.445.9288 or toll-free at 866.289.6911. We would be happy to help you.
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