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What is the purpose of a clinical study?
The purpose of a clinical study (also called a “clinical trial” or “research trial”) is to determine the safety and effectiveness of treatment options for specific health conditions. Although there are many types of clinical studies, all must conform to strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical research studies. |
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What will I need to do if I decide to take part in this clinical study?
If you choose to take part in this study, you will be asked to:
• Read and sign the Informed Consent form
• Schedule and attend required study visits
• Complete specific tests and questionnaires to document your progress
• Quickly report any problems to your physician |
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How long will I be involved in this clinical study?
Following your treatment, you will be scheduled for return visits at 1-week, then at months 1, 2, 3, and 6, and annually for 5 years. During these visits, your study doctor will evaluate your circulation using non-invasive tests to determine the effectiveness of the treatment you received. |
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How is the investigational treatment performed?
To perform the treatment, after you receive local anesthesia and sedation, your doctor will draw blood from your arm and place a needle into each hip bone to collect bone marrow aspirate (BMA), a fluid that resembles blood. This fluid will be withdrawn into a syringe and then processed in a special centrifuge system that separates and concentrates certain cells in 15 minutes. Following this, your doctor will use a thin needle to inject the processed BMA or blood near the blocked blood vessels of your leg, as well as around any areas of ulcers or gangrene (if present). |
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How long will the procedure take?
You will be given instructions concerning the time in the morning when you should come to the hospital. You will receive the treatment and will recover for a few hours after the procedure. You should expect to be released from the hospital by the end of the afternoon. |
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How painful is the treatment?
The entire procedure is performed under the supervision of an anesthesiologist. The anesthesiologist will discuss with you the various anesthetic options available to you. Persons who have had the procedure have generally reported mild discomfort at the place on the hip where the bone marrow was taken and in the area of the leg injections, and they report that the discomfort is gone in about 24 hours. |
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When can I expect to see benefit from the treatment?
Because this is an investigational treatment the answer to this question is not known. In the clinical studies that have been published to date, benefit is reported within 8 to 12 weeks. It must be remembered, however, that some patients who have received the treatment have not shown any benefit. |
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Can I have the investigational treatment without joining the clinical study?
No, the stem cell treatment being offered through this study is investigational (which means it has not yet been approved for general use by the FDA); as such, this treatment is only available to patients taking part in the study. |
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How come some patients in this study will undergo the investigational treatment, while others will undergo a control treatment?
The purpose of this study is to evaluate the safety and effectiveness of using cells from a patient’s own bone marrow and injecting them into the leg to possibly improve blood flow. To help researchers determine if this treatment is effective, it must be compared to a simulated treatment (also called a “control” treatment). As part of this study, 2 out of every 3 patients will undergo the investigational treatment (injecting stem cells from bone marrow into the leg), while 1 out of every 3 patients will undergo the control treatment (injecting diluted blood into the leg). The decision as to which treatment you will undergo (investigational or control) is made at random (like flipping a coin). You will have a 2 in 3 chance or receiving the investigational treatment. However, regardless of which treatment you undergo, neither you nor your study doctor will know which treatment you received. |
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Where is this clinical study being conducted?
This study is being conducted at several specialized centers throughout the U.S. Click here to see a list of current study locations. |
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Are there any costs involved in this study?
You will not be responsible for any costs that are required solely for the purpose of the study. This includes bone marrow collection and preparation, medical procedures,
study-specific tests, and post-treatment evaluations. |
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Will I be paid to participate in the study?
No, you will not receive any payment for participating in the study. |
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What company is responsible for this clinical study?
The company sponsoring this study is Harvest Technologies, Inc, headquartered in Plymouth, MA. Harvest Technologies is dedicated to improving patient outcomes by enhancing the body’s normal healing process using adult stem cells and growth factors. |
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What if I join the study and decide I do not want to participate anymore?
You will be fully informed of the study schedule and the planned follow up visits, before you enroll in the study. If you know that you will be unable to complete the planned follow-up visits, you should not join in this research study. However, as with all clinical trials, your participation is completely voluntary and you may leave the study at any time. This will not affect your medical care or relationship with any of your doctors. |
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When will I know if I am eligible?
When you contact the Study Office at the study location most convenient to you, you will be asked more questions and then will be asked to come to the hospital for a series of tests to determine if you qualify. The Study Coordinator will then contact you to confirm your eligibility and schedule treatment. |
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