On April 26, 2005 a federal document was released describing the national guidelines for human embryonic stem cell research in order to regulate how stem cell research is performed and to minimize controversy. This document was complied by the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine and the National Research Council. Premise for creating the document was based on the fact that human embryonic stem cells may have the ability to provide great improvements in human health. Although the potential for lifestyle improvement is great, stem cell research must be regulated to prevent inappropriate application of this relatively new discovery.

Above is an image of an embryonic stem cell in an extracellular matrix.

Where do the Human Embryos come from?

Assisted Reproductive Technology (ART) was created over 20 years ago to overcome fertility problems. ART utilizes In Vitro Fertilization (IVF), which is fertilization of an egg by a sperm outside the body (for example, in a petri dish). Many ART procedures result in an excess amount of embryos and the people involved in creating those embryos have the option of cryopreserving them to be stored for future attempts to enable pregnancy. Over 400,000 of these cryopreserved embryos are stored in the United States alone. Therefore, once the “owners” of the embryo choose to terminate treatment, they have a number of options for their excess embryos. One of those options is to donate them for research purposes. The only way to get these embryos (which are in the form of blastocysts) into labs for research is to get consent from all of the gamete donors for the blastocyst to be used in research.

Above is am image of an eight cell embryo obtained from an In Vitro Fertilization Program (IVF).

How are Embryos Stored?

Storage, maintenance, and distribution of cell lines must also adhere to certain national standards. There exist national stem cell banks** (and international stem cell banks as well) that store stem cells according to legal requirements. They are established for various functions to ensure legitimate protocol. On the privacy plane, stem cell banks ensure that the rights of the gamete donors have not been abused and make sure that proper consent forms by all gamete donors are completed and accurate. These banks also limit the number of embryos that any one institution can receive, which is vital in regulating abuse of stem cell research. Further regulation of storing and obtaining tissues lies in the requirement that any identifiable tissue is required to pass an Institutional Review Board (IRB) review at the collection site.

Quality Assurance of Embryos

Safety, security, and risk assessments are performed on the management side of this issue in order to ensure appropriate handling and storage of the embryos. This is vital to maintain high quality stem cells for research and clinical studies. Validating submitted tissues, culturing and expanding cell lines, process control, packaging for distribution and documentation are all processes that are monitored and constantly checked by the quality management team of the stem cell banking facility. Detailed reports of every aspect for every tissue that enters a banking facility are required in order to assure accuracy and enable tracking. It is increasingly vital for research institutions to obtain high quality cell lines as they approach their in vivo testing. Poor stem cell quality could create adverse effects on the test subject’s body and put the subject’s life in danger.

All information obtained from Guidelines for Human Embryonic Stem Cell Research.

-Amy

A 65 year old man with end-stage cardiomyopathy and severe hypertension desperately needed a heart. After September 11, 2001, Castelio Campos received news that one of the victims of 9/11 had a heart that was a match for him.  He eagerly arrived and the hospital, was anesthetized, and then awoke before the surgery had been completed.  The nurses informed him that unfortunately, the heart was not a perfect match.  Mr. Campos was also told that he would have to wait in the hospital until they found a heart for him.  After a few months, he was highly ischemic and had advanced pulmonary hypertension, so surgeons at the University of Miami strove to find a way to help him.
The surgeons decided to preform a heterotopic heart transplant in which they left his native (N) heart in and went forward with the transplant of a not-so-perfect donor heart. They placed the allopathic donor heart (D) right next to his native heart (as shown in the two figures below). As can be seen on the EKG below, this patient is living with two QRS complexes on different axes.  Thanks to Mr. Campos’ successful surgery, there are now about 100 people in the world living with two hearts.

In the figure above, visual A shows the patient’s EKG results and differing QRS complexes can be viewed by at the arrows D (donor heart) and N (native heart). Visual B shows a front view of the patient in which a cardiac defibrillator is treating the native heart. Visual C shows the top view and demonstrates the close proximity of the two hearts and the amount of space they occupy in the chest cavity.

Information obtained from the American Heart Association and the New England Journal of Medicine.

-Amy

In my previous article, The Basics of Heart Failure, it was mentioned that a ventricular-assist device (VAD) is the primary treatment for heart failure. Dr. William Wagner (who also contributed to the positive displacement pump technology previously mentioned) believes that there is much room for improvement in the biocompatibility of VADs. he spoke at the BMES conference of infection and thrombosis (blood clotting) problems upon implantation of VADs into patients.

Infection due to VADs can be caused by the biomaterial used, poor sterile technique, device failure, and percutaneous line design. Shear forces caused by excessive bleeding upon implantation of the device can also cause infection, and infection leads to tissue necrosis.

Thrombosis and thromboembolism are problems that all devices face when coming into contact with blood. To avoid this issue, surgeons use drugs like Heparin or Coumadin to avoid coagulation when devices come into direct contact with the blood.

Many scientists believe that nothing can be solved unless it can be quantified. Infection and thrombosis (believe it or not) can be crudely measured through microembolic signals (MES). Dr. Wagner suggested that scientists should get more out of animal models by analyzing MES, explants, and gross neurological health more thoroughly to minimize plately aggregation and avoid thrombosis. An example of a thoroughly tested device that has been underway for 30 years is the Heartmate II, which is implanted in the chest to aid the heart in pumping (shown in the figure above). This device can be used as a treatment method for patients with severe heart failure, or as a bridge until a transplant is available. When tested in calves, this device showed a spike in platelet aggregation (which is expected and normal) and then a steady decrease in aggregation due o microaggregates leaving the implant site. In previous VADs, the platelet aggregation spiked and then didn’t decline at a steady enough rate for thrombosis to cease. Another research project underway by EvaHeart to improve the downfalls of VADs is to replace bovine (cow) with ovine (sheep) products due to this superior configuration of ovine tissue (methacryloyloxyethyl phosphorylcholine).

-Amy

To my Readers:

I attended the BMES (Biomedical Engineering Society) Fall Meeting from September 26th until the 29th. Last year the conference was held in Chicago, this year it was in Hollywood. The theme of this year’s conference was “Engineering the Future of Biology and Medicine”. The Biomedical Engineering Department at UC Irvine compensated the entire George Lab (and myself) for the conference this year!

It was an amazing experience! Anyone who has the opportunity to attend next year definitely should. There are several tracks from which one can chose their area of interest, for example respiratory engineering, biomaterials and tissue engineering, cardiovascular engineering, and a few more. For each track, there are several talks scheduled and many posters presented at the conference.

I met many prestigious people, learned how to improve my own experiments, and discovered several break-throughs in the field of biomedical engineering. My attendance at this conference benefits all you readers as well because I have quite a few interesting articles lined up. From tissue engineering to industry to biocompatibility of heart devices to interesting people…keep up with www.AmyShah.com this week for all the exciting first-hand stories.

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