The shared theories in both trials is that the specialized cells could have the ability to promote blood vessel growth, prevent cell death and transform themselves into a number of tissues, including muscle. After an acute heart attack, a remodeling process was initiated in the heart in an attempt to compensate for the damaged areas.
Researchers surmised that the condition of the heart muscle several weeks after the attack may differ considerably from the heart muscle in the acute stage setting. For some patients delaying the delivery of stem cells by two to three weeks may have been better than initiating the treatment during the acute phase.
All patients underwent baseline assessments that included medical history, physical exam, electrocardiogram, blood draws, echocardiogram and MRI tests. Participants were then assigned randomly to receive the stem cells or placebo within the aforementioned two to three week timeline.
The morning of stem cell or placebo infusion, a blood draw and bone marrow aspiration procedure of the hip bone are conducted to collect the stem cells. Later the same day, either stem cells or placebo are then infused through a catheter and directly into the damaged area of the heart.
Following the first 24 hours of the infusion, participants wear a small ECG machine, or Holter monitor. Additionally, patients record their body temperature twice a day for 30 days post infusion. Follow up visits at months one, three, six, 12 and 24 where baseline assessment testing are conducted.
The TIME trial adjusts that variable and results will be published in two years.
|SOURCE University Hospitals Case Medical Center|
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