Trojan-Horse Therapy- New Hope for Metastasis Cancer Patients

Metastasis Cancer 

It is actually spreading of Cancer Cells from the place where it first started to another place in the body. Any type of Cancer can turn into Metastatic cancer. Metastatic cancer has the same name and the same type of cancer cells as the original, or primary, cancer. For example, breast cancer that spreads to the lungs and forms a metastatic tumor is metastatic breast cancer, not lung cancer.

Persons who have been already treated for cancer are at a high risk of developing metastasis cancer.

Mode of Metastasis

Cancer Cells metastasize by gaining access to the circulatory system, which includes Blood, vessels to transport the blood, and a heart to pump the blood, lymphatic system . Once inside a blood vessel, cancer cells can drift virtually anywhere in the body.
Cancer cells differ from normal cells in three ways:
(1) they divide when they should not;
(2) they invade surrounding tissues; and
(3) they move to other locations in the body.
Any tissue that undergoes cell division is susceptible to becoming cancerous.

A common cancer cell spreading pattern. Development of metastasis cancerous cell.

Fact 

The survival rate is very low in case of Cancer become metastasis. Even with continuous chemotherapy, chances of survival is very low.

Survival Rate (For five-year Period) : 70%

Survival Rate (After five-year Period): 10-20%

To See Study on survival rate of Metastasis Breast Cancer: Click Here

Treatment

1. Only few metastatic cancer can be cured to currents treatments.

2. In most cases of metastatic cancer, the goal of treatment is to control the growth of the cancer or to relieve the symptoms. Most cases, the death of cancer is due to metastatic cancer. Treatment only prolongs life. No Cure at the moment.

Future Outlook of Treatment

Metastasis Cancer treatment future outlook is still in nascent stage. Not a single method of treatment is tested outside the lab till now. There is two or three techniques which has shown promising results on animals. You might want to participate in the clinical trails if your cancer has stopped responding to the chemotherapy and radiation therapy.

Trojan Horse Therapy:   

In this therapy, viruses attack the cancerous cells. The White Blood cells are mixed with the viruses which further delivers viruses inside the body. A research group in UK under Dr Emma Smith takes blood samples and extract macrophages (a part of the immune system which normally attacks foreign invaders).

Properties of Viruses Used

1. Avoid being attacked like HIV.

2. Travels with White Blood Cell.

In the study, the mice were injected with the white blood cells two days after a course of chemotherapy ended.

At this stage each white blood cell contained just a couple of viruses. However, once the macrophages enter the tumour the virus can replicate. After about 12 hours the white blood cells burst and eject up to 10,000 viruses each – which go on to infect, and kill, the cancerous cells.

Mechanism of Action: The oncolytic viruses divide themselves in the white blood cells. The division keeps going on until the cell burst takes place and viruses deliver into Cancerous cells.

This therapy needs to do simultaneous with the chemotherapy or radiation therapy as the white blood cells formed at a rapid pace after chemo in order to mitigate the damage of body from chemo. So, rapid formation of WBC’s help in viruses to divide in more number.

Promising Result:

Mice has been completely cured from the metastasis Prostate cancer after 40 days this treatment  in comparison to other mice who has been died without this therapy.

But, the research is still at an early stage and tests to show it is safe and effective in humans are still needed.

Link to research article : Click Here

Link to news article: Click Here

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Cancer : A Student’s Story

Nicole’s early college career was similar to that of most students. She enjoyed her independence and the wide variety of courses her majors in biology and psychology required her to take. She worried about her grades and finding ways to balance her course work with her social life. She also tried to find time to lift weights in the school’s athletic center and to snowboard at a local ski hill. Some weekends, to take a break from school, she would ride the bus home to see her family. Managing to get schoolwork done, see friends and family, and still have time left to work out had been difficult, but possible, for Nicole during her first two years at school. That changed drastically in her third school year.

One morning in October of her junior year, Nicole began having episodes of severe abdominal cramping. The first time this happened, she was just beginning an experiment in her cell-biology laboratory course. Hunched over and sweating, she barely managed to make it through the two-hour respiration experiment she and her lab partner were performing. Over the next few days, the cramps intensified so much that she was unable to walk from her apartment to her classes without stopping several times to rest. Later that week, as she was preparing to leave for class, she had a cramp that was so severe that she had to lie down in the hallway of her apartment. When her roommate got home a few minutes later, she took Nicole to Student Health Services for an emergency visit.

The physician at Health Services first determined that Nicole’s appendix had not burst, and then made an appointment for Nicole to see a local gynecologist the next day. After hearing Nicole’s symptoms, Nicole’s gynecologist pressed on her abdomen and felt what he thought was a mass on her right ovary. He used a non-invasive procedure called ultrasound to try to get an image of her ovary. This procedure requires the use of high-frequency sound waves. These waves, which cannot be heard by humans, were aimed at the ovaries. The pattern of echoes they produced created a picture called a sonogram. Healthy tissues, fluid-filled cysts, and tumors all look different on a sonogram.
Nicole’s sonogram convinced her gynecologist that she had a large growth on her ovary. He told her that he suspected that this growth was a cyst, or fluid-filled sac. Her gynecologist told her that cysts often go away without treatment, but this one seemed to be quite large so it would need to be removed. After her appointment, Nicole went home and called her professors to let them know she would be missing classes for the next week because she would be having surgery.

Even though the idea of having an operation was scary for Nicole, she was relieved to know that the pain would stop; her gynecologist had also assured her that she had nothing to worry about, because cysts are not cancerous. A week after the abdominal cramps began; the cyst and her completely engulfed right ovary were surgically removed through an incision just below her navel. The cystic ovary was then sent to a scientist who specializes in determining whether tissues are cancerous or not. The scientist, called a pathologist, determined that Nicole’s doctor had been right—she found no sign of cancer.

After the operation, Nicole’s gynecologist assured her that the remaining ovary would compensate for the missing ovary by ovulating (producing an egg cell) every month. Her doctor also informed her that he would have to carefully monitor her remaining ovary to make sure that it did not become cystic, or even worse, cancerous. She could not afford to lose another ovary if she wanted to remain fertile and have children some day.

Monitoring her remaining ovary involved monthly visits to her gynecologist’s office where Nicole would have her blood drawn and analyzed. The blood would be tested for the level of a protein called CA125, which is produced by ovarian cells. Higher-than-normal CA125 levels usually indicate that the ovarian cells have increased in size or number, and are thus associated with the presence of an ovarian tumor.

Nicole went to her scheduled check-ups for five months after surgery. The day after her March check-up, Nicole received a message from her doctor asking that she come to see him the next day. Because she needed to study for an upcoming exam, Nicole tried to push aside her concerns about the appointment, and by the time she arrived at her gynecologist’s office she had convinced herself that nothing serious could be wrong. She thought a mistake had probably been made and that he wanted to perform another blood test.When her gynecologist entered the exam room, Nicole could tell by his demeanor that something was wrong. He started speaking to her and she began to feel very anxious—he told her that he thought she had a tumor on her remaining ovary, but she could not believe that she had heard him correctly.When her gynecologist said the word Cancer, she felt as though she was being pulled under water. She could see that he was still talking, but she could not hear or understand him. She was too nauseous to think, so she excused herself from the exam room, took the bus home, and immediately called her mom. After speaking with her mom, Nicole realized that there were many questions she needed to ask her doctor.

She did not understand how it was possible for such a young woman to have lost one ovary to a cyst, and then have a tumor on the other ovary. She wondered how this would be treated, and what her prognosis would be. Despite her background in biology, she did not even really understand what cancer was. Nicole decided to do some research for answers to her questions.

Risk Factors = Cancer

Risk Factors

Doctors often cannot explain why one person develops cancer and another does not. But, there are certain risk factors which increase the chance that a person will develop cancer. These are the most common risk factors for cancer:

• Growing older
• Tobacco
• Sunlight
• Ionizing radiation
• Certain chemicals and other substances
• Some viruses and bacteria
  
• Certain hormones
  
• Family history of cancer
• Alcohol
• Poor diet, lack of physical activity, or being overweight

Many of these risk factors can be avoided. Others, such as family history, cannot be avoided.

If you think you may be at risk for cancer, you should discuss this concern with your doctor. You may want to ask about reducing your risk and about a schedule for checkups.

Over time, several factors may act together to cause normal cells to become cancerous. When thinking about your risk of getting cancer, these are some things to keep in mind:

• Not everything causes cancer.
• Cancer is not caused by an injury, such as a bump or bruise.
• Cancer is not contagious. Although being infected with certain viruses or bacteria may increase the risk of some types of cancer, no one can “catch” cancer from another person.
• Having one or more risk factors does not mean that you will get cancer. Most people who have risk factors never develop cancer.
• Some people are more sensitive than others to the known risk factors.

The sections below have more detailed information about the most common risk factors for cancer.

Growing Older

The most important risk factor for cancer is growing older. Most cancers occur in people over the age of 65. But people of all ages, including children, can get cancer, too.

Tobacco

Tobacco use is the most preventable cause of death. Using tobacco products or regularly being around tobacco smoke (environmental or secondhand smoke) increases the risk of cancer.

Smokers are more likely than nonsmoker to develop cancer of the lung, larynx (voice box), mouth, esophagus, bladder, kidney, throat, stomach, pancreas, or cervix. They also are more likely to develop acute myeloid leukemia (cancer that starts in blood cells).

People who use smokeless tobacco (snuff or chewing tobacco) are at increased risk of cancer of the mouth.

Quitting is important for anyone who uses tobacco – even people who have used it for many years. The risk of cancer for people who quit is lower than the risk for people who continue to use tobacco. (But the risk of cancer is generally lowest among those who never used tobacco.)

Also, for people who have already had cancer, quitting may reduce the chance of getting another cancer. An US Government Website, http://www.smokefree.gov, has an online guide to quitting smoking and a list of other resources.

Sunlight

Ultraviolet Radiation(UV) comes from the sun, sunlamps, and tanning booths. It causes early aging of the skin and skin damage that can lead to skin cancer.

Doctors encourage people of all ages to limit their time in the sun and to avoid other sources of UV radiation:

• It is best to avoid the midday sun (from mid-morning to late afternoon) whenever possible. You also should protect yourself from UV radiation reflected by sand, water, snow, and ice. UV radiation can penetrate light clothing, windshields, and windows.
• Wear long sleeves, long pants, a hat with a wide brim, and sunglasses with lenses that absorb UV.
• Use sunscreen.

Ionizing radiation

Ionizing Radiation can cause cell damage that leads to cancer. This kind of radiation comes from rays that enter the Earth’s atmosphere from outer space, Radioactive fallout, Radon Gas, X-Rays, and other sources.

Radioactive fallout can come from accidents at nuclear power plants ( like Fukushima Daiichi nuclear disaster) or from the production, testing, or use of atomic weapons. People exposed to fallout may have an increased risk of cancer, especially leukemia and cancers of the thyroid, breast, lung, and stomach.

Radon is a radioactive gas that you cannot see, smell, or taste. It forms in soil and rocks. People who work in mines may be exposed to radon. People exposed to radon are at increased risk of lung cancer.

Medical procedures are a common source of radiation:

• Doctors use radiation (low-dose x-rays) to take pictures of the inside of the body. These pictures help to diagnose broken bones and other problems.
• Doctors use radiation therapy (high-dose radiation from large machines or from radioactive substances) to treat cancer.

The risk from radiation therapy is slightly higher. You should talk with your doctor or dentist about the need for each x-ray. You should also ask about shields to protect parts of the body that are not in the picture.

Cancer patients may want to talk with their doctor about how radiation treatment could increase their risk of a second cancer later on.

Certain Chemicals and Other Substances

People who have certain jobs (such as painters, construction workers, and those in the chemical industry) have an increased risk of cancer. Many studies have shown that exposure to asbestos, benzene, benzidine, cadmium, nickel, or vinyl chloride in the workplace can cause cancer.

Follow instructions and safety tips to avoid or reduce contact with harmful substances both at work and at home. Although the risk is highest for workers with years of exposure, it makes sense to be careful at home when handling pesticides, used engine oil, paint, solvents, and other chemicals.

Some Viruses and Bacteria

Being infected with certain viruses or bacteria may increase the risk of developing cancer:

• Human papillomaviruses (HPVs): HPV infection is the main cause of cervical cancer. It also may be a risk factor for other types of cancer. Do not have unprotected sex or share needles. You can get an HPV infection by having sex with someone who is infected.
• Hepatitis B and hepatitis C viruses: Liver cancer can develop after many years of infection with hepatitis B or hepatitis C. You may want to consider getting the vaccine that prevents hepatitis B infection.
• Human T-cell leukemia/lymphoma virus (HTLV-1): Infection with HTLV-1 increases a person’s risk of lymphoma and leukemia.
• Human immunodeficiency virus (HIV): HIV is the virus that causes AIDS. People who have HIV infection are at greater risk of cancer, such as lymphoma and a rare cancer called Kaposi sarcoma.
• Epstein-Barr virus (EBV): Infection with EBV has been linked to an increased risk of lymphoma.
• Human herpesvirus 8 (HHV8): This virus is a risk factor for Kaposi’s sarcoma.
• Helicobacter pylori : This bacterium can cause stomach ulcers. It also can cause stomach cancer and lymphoma in the stomach lining.

If you think you may be at risk for HIV or hepatitis infection, ask your doctor about being tested. These infections may not cause symptoms, but blood tests can show whether the virus is present. If so, the doctor may suggest treatment. Also, the doctor can tell you how to avoid infecting other people.

If you have stomach problems, see a doctor. Infection with H. pylori can be detected and treated.

Certain Hormone

Doctors may recommend hormones (estrogen alone or estrogen along with progestin) to help control problems (like hot flashes, vaginal dryness, and thinning bones) that may occur during menopause. However, menopausal hormone therapy can cause serious side effects.

Hormones may increase the risk of breast cancer, heart attack, stroke, or blood clots.

A woman considering menopausal hormone therapy should discuss the possible risks and benefits with her doctor.

Family History of Cancer

Most cancers develop because of changes (mutations) in genes. A normal cell may become a cancer cell after a series of gene changes occur. Tobacco use, certain viruses, or other factors in a person’s lifestyle or environment can cause such changes in certain types of cells.

Some gene changes that increase the risk of cancer are passed from parent to child. These changes are present at birth in all cells of the body. Certain types of cancer do occur more often in some families than in the rest of the population. For example, Melonoma, breast, ovary, prostate, and colon cancers sometimes run in families. This is linked to inherited gene changes, which may increase the chance of developing cancers. However, environmental factors may also be involved. Most of the time, multiple cases of cancer in a family are just a matter of chance.

If you think you may have a pattern of a certain type of cancer in your family, you may want to talk to your doctor. Your doctor may suggest ways to try to reduce your risk of cancer. Your doctor also may suggest exams that can detect cancer early.

You may want to ask your doctor about genetic testing. But inheriting a gene change does not mean that you will definitely develop cancer.

Alcohol

Having more than two drinks each day for many years may increase the chance of developing cancers of the mouth, throat, esophagus, larynx, liver, and breast. The risk increases with the amount of alcohol that a person drinks. For most of these cancers, the risk is higher for a drinker who uses tobacco.

Doctors advise people who drink to do so in moderation. Drinking in moderation means no more than one drink per day for women and no more than two drinks per day for men.

Poor Diet, Lack of Physical Activity, or Being Overweight

People who have a poor diet, do not have enough physical activity, or are overweight may be at increased risk of several types of cancer. For example, studies suggest that people whose diet is high in fat have an increased risk of cancers of the colon, uterus, and prostate. Lack of physical activity and being overweight are risk factors for cancers of the breast, colon, esophagus, kidney, and uterus.

Finally, a detailed study on different avoidable risk factors associated with cancer are given below:

 

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Metastatic Breast Cancer and Cryoablation

Individuals fighting metastatic breast cancer, where the disease has progressed to other areas of the body, may finally have another weapon in their arsenal: percutaneous cryoablation. The cancer treatment could potentially be used as a last line of defense to halt individual spots of remaining metastatic disease by freezing and destroying tumors, say researchers presenting a study at the Society of International Radiology’s 37th Annual Scientific Meeting in San Francisco, Calif.

Cryoablation is a local treatment for single, small metastatic breast cancer tumors, especially in women who aren’t good surgery candidates. Guided by imaging (ultrasound, CT scan, or MRI), cryoablation inserts a special freezing probe (a type of catheter) through the skin and to the tumor to be treated. Once the tip of the probe is in the right spot inside the tumor core, pressurized argon gas is injected through the probe into the tumor, freezing and destroying the cancerous tissue. Cryoablation techniques may vary from one cancer treatment facility to another. Cryoablation is more common in cases where the breast cancer is being well controlled by systemic treatments. Cryoablation may also be called percutaneous ablation, cryosurgery or cryotherapy.

Advantage of Cryoablation over Surgery:

1. Cryoablation has little to no recovery time.

2. Cryoalblation provides a minimal rate of cancer recurrence and no major complications.

3.  For many metastatic patients, who are not candidates for surgery. cryoablation gives an opportunity to them for survival.

Experimental results:

The eight women survived for an average of about 4 years from the time metastatic breast cancer was diagnosed and an average of 2.5 years after cryoablation. Four of the women lived for more than 5 years after being diagnosed with metastatic breast cancer.

Already, Cryoablation is used in the treatment of

1. Prostate Cancer

2. Retinoblastoma (a childhood cancer that affects the retina of the eye).

3. Early-stage skin cancers (both basal cell and squamous cell carcinomas).  

4. Precancerous conditions of the cervix known as cervical intraepithelial neoplasia (abnormal cell changes in the cervix that can develop into cervical cancer).

Nanoscale Velcro-like device- To Capture And Release Tumour Cells at Low Temperature

A new-generation nano-platform capable of capturing circulating tumor cells and releasing them at reduced temperature.

This new nanotechnology device could be used for cancer diagnosis and give insight into the mechanisms of how cancer spreads throughout the body. The device provides a convenient and non-invasive alternative to biopsy, the current method for diagnosis of metastatic cancer.

It could enable doctors to detect tumor cells that circulate in cancer patients’ blood well before they subsequently colonize as tumors in other organs. The device also enables researchers to keep the tumor cells alive and subsequently study them.

The device was developed by a team led by Hsiao-hua Yu from the RIKEN Advanced Science Institute in Japan and Hsian-Rong Tseng from the Department of Molecular and Medical Pharmacology at the University of California Los Angeles, in research published online today in the journal Advanced Materials.

This technology is unique in that it is capable of catching the tumor cells with great efficiency and releasing them with great cell viability. Blood is passed through the device like a filter that contains a molecule capable of adhering to tumor cells like Velcro and separating them with efficiency ranging from 40% to 70%. The cancer cells are retained by tiny temperature-responsive polymer brushes inside the device. At 37 degrees Celsius, these polymer brushes stick to the tumor cells, but when cooled to 4 degrees Celsius, they release them, allowing scientists to examine the cells.

“Until now, most devices have demonstrated the ability to capture circulating tumor cells with high-efficiency. However, it is equally important to release these captured cells, to preserve and study them in order to obtain insightful information about them.

Cancer and GM Crops

BT toxins from the bacteria, Bacillus Thuringiensis, have been inserted into genetically engineered food crops (GMO) to kill insects. As a result, the BT toxins have reached the bloodstreams of 93% of women, and 80% of unborn babies because of the consumption of meat, milk, and eggs from livestock fed GE corn. Once the BT toxins are present in the gut, it mutates the healthy bacteria in our intestines turning them into persistent pesticide factories living within our body.

 

SNP’s Role in Cancer

Genome-wide studies have identified certain single-nucleutide polymorphisms (SNPs), mutations at specific points in the DNA, that increase a person’s risk of developing cancer. Yet, research so far has shown that most SNPs likely only have a modest effect on risk. In the 7 December issue, Sur et al. used a mouse model to look at the functional impact of a particular SNP linked with cancer risk. Mice with this mutation developed intestinal tumors, and when the mutation was deleted, mice displayed fewer tumors. This study suggests that this specific SNP may play a causal role in human cancer.

Healthy Living Style – SaY No to CANCER and Chemo

AFTER YEARS OF TELLING PEOPLE CHEMOTHERAPY IS THE ONLY WAY TO TRY AND ELIMINATE CANCER, THERE IS AN ALTERNATIVE WAY FROM OLD DAYS…

1. Every person has cancer cells in the body. These cancer cells do not show up in the standard tests until they have multiplied to a few billion. When doctors tell cancer patients that there are no more cancer cells in their bodies after treatment, it just means the tests are unable to detect the cancer cells because they have not reached the detectable size.

2. Cancer cells occur between 6 to more than 10 times in a person’s lifetime.

3. When the person’s immune system is strong the cancer cells will be destroyed and prevented from multiplying and forming tumors.

4. Changing diet and including supplements will strengthen the immune system.

5. Chemotherapy involves poisoning the rapidly-growing cancer cells and also destroys rapidly-growing healthy cells in the bone marrow, gastro-intestinal tract etc, and can cause organ damage, like liver, kidneys, heart, lungs etc.

6. Radiation while destroying cancer cells also burns, scars and damages healthy cells, tissues and organs.

7. Initial treatment with chemotherapy and radiation will often reduce tumor size. However prolonged use of chemotherapy and radiation do not result in more tumor destruction.

8. When the body has too much toxic burden from chemotherapy and radiation the immune system is either compromised or destroyed, hence the person can succumb to various kinds of infections and complications.

9. Chemotherapy and radiation can cause cancer cells to mutate and become resistant and difficult to destroy. Surgery can also cause cancer cells to spread to other sites.

What cancer cells feed on:

a. A diet made of 80% fresh vegetables and juice, whole grains, seeds, nuts and a little fruits help put the body into an alkaline environment. About 20% can be from cooked food including beans. Fresh vegetable juices provide live enzymes that are easily absorbed and reach down to cellular levels within 15 minutes to nourish and enhance growth of healthy cells. To obtain live enzymes for building healthy cells try to drink fresh vegetable juice (most vegetables including bean sprouts) and eat some raw vegetables 2 or 3 times a day. Enzymes are destroyed at temperatures of 104 degrees F (40 degrees C).

b. Avoid coffee, tea, and chocolate, which have high caffeine. Green tea is a better alternative and has cancer-fighting properties.

c. Water–best to drink purified water, or filtered, to avoid known toxins and heavy metals in tap water. Distilled water is acidic, avoid it.

10. Some supplements build up the immune system (IP6, Flor-ssence, Essiac, anti-oxidants, vitamins, minerals, EFAs etc.) to enable the body’s own killer cells to destroy cancer cells. Other supplements like vitamin E are known to cause apoptosis, or programmed cell death, the body’s normal method of disposing of damaged, unwanted, or unneeded cells.

11. Cancer is a disease of the mind, body, and spirit. A proactive and positive spirit will help the cancer warrior to be a survivor.

Anger, unforgiving and bitterness put the body into a stressful and acidic environment. Learn to have a loving and forgiving spirit. Learn to relax and enjoy life.

12. Cancer cells cannot thrive in an oxygenated environment. Exercising daily, and deep breathing help to get more oxygen down to the cellular level. Oxygen therapy is another means employed to destroy cancer cells.

*Lung cancer in women ‘to soar’ by 2040*

The number of women living with lung cancer in the UK is set to rise significantly faster than the number of men with the disease over the next 30 years, experts say.
Lung cancer kills more people in the UK than any other cancer. Cases of lung cancer reflect smoking rates two to three decades earlier, and about 80% of cases are linked to tobacco.

The peak time for smoking in women was in the 1960s – 20 years after the peak in male smoking.
And while cases in women will far exceed those in men, the charity says that by 2040 fewer than half (47%) of women with lung cancer will be alive at least five years from diagnosis compared with three-fifths (59%) of men.

Breast Cancer- Some Preventive Measures for Breast Cancer

1. Younger women who wait at least 15 years after their first menstrual period to give birth to their first child may reduce their risk of an aggressive form of breast cancer by up to 60 percent, according to a Fred Hutchinson Cancer Research Center study. The findings, by Christopher I. Li, M.D., Ph.D., a member of the Public Health Sciences Division at Fred Hutch, are published online in Breast Cancer Research and Treatment.

2. Breast-feeding confers a protective effect against triple-negative disease. “Breast-feeding is emerging as a potentially strong protective factor against one of the most aggressive forms of breast Cancer.

3. A little squeeze may be all that is required to prevent malignant breast cells triggering cancer, research has shown. Laboratory experiments showed that applying physical pressure to the cells guided them back to a normal growth pattern. The study involved growing malignant breast epithelial cells within a gel injected into flexible silicone chambers. This allowed the scientists to apply compression during the first stages of cell growth, effectively squashing the cells. Over time, the squeezed malignant cells began to grow in a more normal and organised way. Once the breast tissue structure was formed the cells stopped growing, even when the compressive force was removed. The results were presented at the annual meeting of the American Society for Cell Biology in San Francisco by Mr Venugopalan, a doctoral student at the University of California in Berkeley, United States.