Search our website Find job opportunies at THI and St. Luke's Find a doctor location and contact information
About UsPatient CareHeart information Center EducationResearchSupport The Texas Heart Institute
Stem Cell Center
 
  Back to previous page
  En espa�ol

 

View a video about stem cell research at Texas Heart Institute.
View a video about stem cell research at Texas Heart Institute.

Clinical Trials
| Share

What is a clinical trial? 

A clinical trial is a research study in which patients may volunteer to take part. The Stem Cell Center (SCC) at the Texas Heart Institute uses clinical trials to further the understanding of stem cells in relation to heart disease.   

Clinical trials are part of a long, careful process, which may take many years. First, doctors study a new treatment in the lab. Then they often study the investigational treatment in animals. If a new research treatment shows promise, doctors then test it on people. Doctors do this in three to four steps, or phases. Phase I trials test to see if an investigational treatment is safe in people. Phase II trials test for efficacy. Phase III trials test if a new treatment is better than a standard treatment.  Finally, the goal of Phase IV trials is to find more information about long-term side effects.   

Is it safe?  

The Stem Cell Center's most important job is to ensure the safety of patients. 

First, the SCC ensures patient safety by following well-planned, FDA approved protocols. A protocol: 

  • Explains the treatment plan 
  • Lists the medical tests patients will receive 
  • Gives the number of patients who will take part in the clinical trial  
  • Lists eligibility criteria, which are guidelines to decide who may join the clinical trial  
  • Explains safety information 

Second, the SCC ensures patient safety by using a careful informed consent process. 

Third, our Institutional Review Boards (IRBs) protect patients by reviewing protocols and monitoring trials. The IRBs are committees of doctors, nurses, chaplains, social workers, lawyers and patients. They make sure that trials follow federal laws and that patients are protected.

The U.S. Food and Drug Administration (FDA) audits the IRBs' files. Also, FDA officials may visit the SCC at any time and review anything they choose related to clinical trials. 

Am I able to take part? 

Not all clinical trials are right for all patients. A trial may be safe for one patient to join, but not safe for another. Each protocol has strict rules that doctors must follow to decide who may join the clinical trial. These rules are called eligibility criteria. This protects patients from getting treatment that may harm them. 

Eligibility criteria include information about you and your overall health: 

  • Age and gender 
  • Results of medical tests  
  • Medicines that you are taking 
  • Your medical history 
  • Your type of heart disease 

How do I sign up?  

Steps to sign up for a clinical trial

If you have found a clinical trial that you think you want to join, please submit a patient information form, and an Intake Coordinator (IC) will contact you within 3 business days. The IC will give you an overview of the trials that are available, and answer any questions you may have.  During this phone call, the IC will also obtain your contact information, and ask a series of questions related to your medical history. In order to determine eligibility for screening, a closer look at your medical history is necessary. So, the IC will send you a medical record release form via fax, mail, or email (or you may download and print a copy here).  Once completed, the form should be returned, and the IC will request medical records from your doctors. 

If you meet pre-screening eligibility requirements after review of your medical records, you will be invited to the Texas Heart Institute for a screening visit.  You will first go through a process called informed consent. The goal of informed consent is to make sure you understand the clinical trial's purpose, plan, risks and benefits. 

The Research Coordinator will review the informed consent form in detail with you. During the informed consent process, please feel free to ask questions. Try to bring a family member or friend to help you ask questions and write down answers. Also, take time to make your decision. If you decide to join the clinical trial, you will be asked to sign the informed consent form. The Research Coordinator will also sign the form, and you will receive a copy.   

What should I look for on the informed consent form? 

Look for the following information on your informed consent form: 

Treatment 

  • The reason for the clinical trial (what the doctors hope to learn) 
  • Who is eligible to take part in the clinical trial 
  • What is known about the type of treatment being studied 
  • Possible risks and benefits (based on what is known so far) 

Tests 

  • Types of tests 
  • How often you would need to undergo testing and meet with the doctor 

Costs 

  • Who pays for the costs of the clinical trial 
  • If the clinical trial causes you to need more medical care, who pays for those costs 

Other 

  • A statement about conflicts of interest (any direct financial benefit to the Texas Heart Institute from the sponsor of the trial) 
  • A statement about how your privacy is protected 
  • Who to call if you have more questions 

The informed consent process does not end once you sign the informed consent form. For example, your doctor must tell you if new risks or side effects of the treatment are found during the trial. Also, please be sure to ask any questions you may have at any time during the trial. 

Top Of Page

Clinical Trials FAQs 

Who would be in charge of my care in the clinical trial? 

Your primary doctor and cardiologist will still care for you. In a clinical trial, you will also have a: 

Principal Investigator (PI): The PI is usually a doctor. He or she runs the clinical trial and makes sure that the health care team follows the plan. 

Research Coordinator: The research coordinator teaches patients about the trial and collects data from patients on the trial. The research coordinator is a good contact if you have questions during a clinical trial. 

Would there be any follow-up after the completion of a clinical trial? 

Yes, you would continue to see your doctor for treatment and follow-up care. 

Do I get paid for clinical trial participation? 

Patients are not given monetary compensation for enrollment into the different studies. However, once enrolled in the trial, patients are not charged for any therapy or monitoring that is directly related to the research.  

Would I be allowed to quit the clinical trial? 

All patients in clinical trials are volunteers. You can choose to quit a clinical trial at any time.  

What happens if I don't meet eligibility criteria for any of your enrolling trials?  

If you don't meet eligibility criteria for any of our trials that are currently enrolling, we will store your contact information and medical history in a database. We will contact you if you appear to meet eligibility for any of our upcoming trials. 

Top Of Page

 

Current Research 

Emerson C. Perin, MD, PhD, FACC


The Stem Cell Center performs clinical and pre-clinical research in the specific area of cardiovascular disease.

We are currently enrolling patients with the following cardiovascular condition:

Patient Forms

 
Member of the Cardiovascular Cell Therapy Research Network
We are a network of physicians, scientists, and support staff dedicated to studying stem cell therapy for treating heart disease.  The goals of the Network are to complete research studies that will potentially lead to more effective treatments for patients with cardiovascular disease, and to share knowledge quickly with the healthcare community.
 


Updated May 2014
Top  
Like us on Facebook Follow us on Twitter Subscribe to us on YouTube Find Us on Flicikr Follow Us on Pinterest Add us on Google+ Find us on LinkedIn

Please contact our Webmaster with questions or comments.
Terms of Use and Privacy Policy
© Copyright 1996-2014 Texas Heart Institute.
All rights reserved.
This website is accredited by Health On the Net Foundation. Click to verify. U.S. NEWS America's Best Hospitals 2013-14