Stem Cell Study
Adult Stem Cells Clinical Study
Oregon Health & Science University is enrolling research participants in a new clinical trial that evaluates whether intravenous infusions of adult stem cells can restore damaged heart tissue in patients after a heart attack. OHSU is the only health center in the Northwest, and one of only approximately 40 in the world, to offer the experimental treatment.
Preliminary tests indicate stem cell therapy administered within a week of a heart attack may reduce inflammation and rebuild damaged heart muscle. The therapy, called Prochymal®, is a formulation of adult stem cells derived from the bone marrow of healthy adult donors.
If proven effective, this would be the first time doctors are able to reverse the cardiac injury inflicted by a heart attack. The therapy also may reduce the chances of developing heart failure.
Dr. Saurabh Gupta, Principal Investigator
"Stem cells are a promising method for regenerating heart muscle, limiting the formation of scar tissue and restoring heart function," says interventional cardiologist Saurabh Gupta, M.D., the director of the cardiac cath lab at OHSU and principal investigator for this trial. "The challenge is finding the best way to deliver the stem cells."
If proven effective, this would be the first time doctors are able to reverse the cardiac injury inflicted by a heart attack. The therapy also may reduce the chances of developing heart failure.
Earlier efforts have involved injecting stem cells directly into damaged heart tissue during heart surgery or using a catheter to infuse stem cells directly into a coronary artery. The new trial evaluates administering the stem cells with an IV, which not only is less invasive, but also is more convenient for patients. "It takes an hour," Gupta says. "And it can be done as an outpatient."
Researchers believe that the swelling that occurs as a result of a heart attack aids the stem cell delivery to the affected area – in this case the heart. "Our current understanding is that the swelling sends out signals that serve as homing devices to the stem cells," Gupta says. "That's why the trial excludes patients with ongoing infections or advanced lung disease."
Study Design
People who receive the treatment will be followed for two years after receiving the stem cell therapy.
Participation in the study includes a thorough health evaluation, study related medications and tests at no cost to the participants.
For additional information about the research study and eligibility, please contact Liz Cannard at 503-494-3961. The study is sponsored by Osiris Therapeutics, Inc. the company that manufactures the stem cell treatment. For more information about Prochymal®, visit OSIRIS Therapeutics.
To enroll:
The objective of the present study is to establish the safety and efficacy of PROCHYMAL® following first acute myocardial infarction.
Medical Condition: Acute Myocaridal Infarction
Doctor/Investigator: Saurabh Gupta
Age Group: Adult
Eligibility Criteria:
Both male and female subjects >21 <85 years of age will be enrolled. Subjects must have experienced a first acute myocardial infarction within 7 days prior to randomization and drug infusion Subjects must have a baseline %EF value of <45% and >30% by quantitative echocardiography using the biplane, modified Simpsons algorithm.
Chance of Placebo:50%
Compensation: None
Duration: 2 years
Recruitment End: April 30, 201
Sponsor: Osiris Therapeutics Inc
IRB#: IRB00005340
The active ingredient of the study drug is adult human Mesenchymal Stem Cells (hMSCs). Adult hMSCs are derived from normal healthy adult volunteer bone marrow donors, and are different from those received during a bone marrow transplant. These cells are found naturally in the body. The cells are not derived from a fetus, embryo, or animal. The study drug is produced in a controlled setting and is tested for possible infectious agents (such as viruses, bacteria, etc) before it is given by infusion into a vein. These cells have shown promise in the treatment of other diseases such as graft-versus-host disease, Crohn's disease and heart attacks.
How It Works
Prochymal, "the study agent", is made of adult human mesenchymal stem cells (hMSCs). Adult hMSCs are derived from normal healthy adult volunteers bone marrow donors; they are found naturally in your body. Adult hMSCs are cells that can develop into a variety of tissue types, including heart cells. These cells have the ability to travel to different parts of the body, regenerate (re-grow) tissue and play a role in tissue damage repair. Adult hMSCs have been studied in different diseases and have been shown to travel to areas of the body to aid in repair of damaged tissue. If tissue is damaged, the cells leave the bone marrow and travel to those areas of the body with damaged tissue. Research suggests that MSCs interact with immune cells (cells that attack infection or are located in areas of inflammation) in the body, reducing inflammation and assisting in tissue repair.
Due to the nature of the damage in the heart after acute myocardial infarction, it is expected that the hMSCs infused into the body will travel to the heart and all areas in the body where there is swelling and injury.
Unlike blood transfusion from one person to another, studies have shown that these cells do not require "matching," between the donor and the person receiving the cells. That is, they can be given to patients with an extremely low chance of being rejected by the body. To date (Dec-2009), the study agent has been administered in treatment protocols to over 300 subjects with different diseases or conditions, including 34 subjects who had recently had a heart attack.
