Wednesday, August 29, 2007

Aug.29, 2007 HAVE A HEART

My name is Catherine Desmond. My husband, Jack (aka John, Tony) had his own stem cells implanted in his heart. I should say, maybe he had stem cells implanted. Chances are he had a placebo implanted.

Wow! More than two months ago, Jack went through this procedure after a few weeks of testing and screening. We were so excited and upbeat and couldn't stop talking about the experience. Donna Perry gave me encouragement and info on blogging, and then I procrastinated about writing on the blog. Actually, we left for a family reunion in South Dakota. That was so much fun and Jack was so up for it, I thought I'd do a family reunion blog ... but .. guess what!

Jack does have a few health issues so his life isn't easy. It would be great to have a stronger heart with better circulation. The other challenges might dwarf a little, if this works.

Comprehensive Cardiovascular Care in Milwaukee is participating in this national study and have put out a flyer describing the study:

Could your own Stem Cells help fight your Angina?
Consider this medical research study

Thank you for your interest in our study.

It is estimated that approximately 6 million people in the U.S. have angina. Because angina typically presents itself through episodes of severe, constricting chest pain cause by a lack of oxygen to the heart, it can be a frightening condition to live with. Although there are current treatments available for angina, not all treatments work well or are effective for everyone. As a result, new treatment options are being explored today, including one option that utilizes a patient's own stem cells.

Everybody's body produces stem cells. Stem cells are simple cells produced by bone marrow that can develop into blood cells or other types of cells. Researchers are interested to learn whether using a patient's own stem cells can lessen the symptoms of angina by helping to restore blood vessels in the heart.

Local doctors are currently conducting a medical research study evaluating the tolerability, safety and effectiveness of an investigational medical treatment involving the use of one's own stem cells into areas of the heart with poor blood flow.

About the Investigational Treatment

The procedure first involves removing an amount of blood from an arm or groin vein using a needle. Specific types of stem cells called CD34+ cells are then separated out of the blood. It is believed that CD34+ cells play a role in new blood vessle generation. These CD34+ cells are then inserted back into areas of the heart that are not receiving enough blood flow, through a small tube called a catheter.

About Your Participation

To pre-qualify for this study you must:
> Be 21 years of age
> Have had a medical diagnosis of chronic angina
>Be identified as unsuitable for conventional revascularization.

Qualified participants will receive a study-related medical evaluation and the investigational treatment at no cost.

If it is determined you are eligible and you decide to participate in this study, your participation could last up to 14 months and you will visit the clinic on at least 13 separate occasions.

During the study visits, various medical tests and evaluations will be performed to monitor your safety and measure your progress throughout the study. These tests and evaluations will include, but not be limited to, physical examinations, chest x-rays echocardiograms and cardiac MRIs.

If you are a woman, you will also be given a pregnancy test to confirm you are not pregnant. If you are pregnant, you will not be allowed to participate in the study.

You will also not be allowed to participate in this study if you have an allergy to E-coli derived proteins, or have been diagnosed with sickle cell disease or sickle cell trait.

About the Study

The primary purpose of this study is to determine the tolerability, safety and effectiveness of one's own stem cells delivered into areas of the heart with poor blood flow.

Upon entering the study, participants will be randomly assigned (similar to picking numbers out of a hat) to one of three treatment groups:
> Group #1 will receive (by injection) 1 x 10 to the fifth power (100,000) cells/kg body weight
> Group#2 will receive (by injection) 5 x 10 to the fifth power (500,000) cells/kg body weight
>Group #3 will receive (by injection) placebo (a substance that looks like your own cells but contains no active ingredients)

You will have a 33% chance (1 in 3) of being in Group#1, a 33% chance (1 in 3) of being in Group#2, and a 33% chance (1 in 3) of being in Group#3. Therefore, there is a 2 in 1 chance that you will receive your CD34+ stem cells.

Neither you nor your doctor will know which procedure you are receiving. The study is designed this way so that the researchers can be certainthat any results are due to the investigational treatment , and not just because the participants think thay are suppose to respond in a certain manner. However, your doctor will be given access to this information should it become necessary due to medical reasons.

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