Thursday, August 20, 2009

Critical Limb Ischemia - Potential Solution and Treatment?

Medical Quarterly
Metro Magazine
August 2009
Duke Testing New Stem Cell Therapy
By Rick Smith

The name is not commonly known and is difficult to pronounce, but the disease afflicts an estimated 12 million Americans. It’s called critical limb ischemia. Treatments are lacking and often require amputation, but help may be on the way: A potential solution for people afflicted with diabetes and obesity who are facing amputation of a limb due to circulatory problems caused by ischemia is soon to begin clinical testing at Duke Uni versity.
The disease causes narrowing and hardening of arteries, thus reducing blood flow. If not treated, victims can suffer nerve and tissue damage. The disease can also trigger gangrene, which often requires amputation.
In lab tests on animals, the use of stem cells not only improved blood flow, but also grew new blood vessels. Dr. Chris Kontos, co-director of the Duke Heart and Vascular Group, will be coordinating the trial that focuses on the stem cell regime developed by Pluristem Thera peutics.
But these are not embryonic stem cells, which have created so much controversy within the medical community. Rather, Pluristem, an Israeli biotherapeutics company whose stock is traded on the Nasdaq, is pioneering the use of stem cells derived from the placenta.
“There is no good medical therapy for critical ischemia,” said Dr. William Prather, who is a consultant with Pluri stem and helped pick Duke as one of the sites for the test. “There are surgical therapies that can clean out the vessels, but there is no medication or procedure to grow new blood vessels around the obstruction. That is what we have proved in animals.”
Duke is currently enrolling subjects for the trials for the Phase I tests of Pluristem’s PLX-PAD solution. A similar trial will take place in Alabama. “Both locations have used other companies’ cells in the past, so they are familiar with stem cell therapy,” Prather said.
Allogeneic Method
Pluristem is working on a variety of products that would enable stem cell transplants between unrelated donors and patients. The concept is called allogeneic, or “taken from different individuals.” The company wants to treat both severe ischemic and autoimmune disorders; it recently received funding support from the Israeli government.
The Pluristem method is not the first to use stem cells as a potential treatment for ischemia, Prather pointed out. How ever, the other choice is stem cells taken from bone marrow. Placenta cells are much more widely available, less expensive and don’t require donors to go through the surgical process to extract cells from the hip.
“We don’t have to do any of that with our cells,” Prather explained. “Our cells come off the shelf, they are one size fit all, they come from material that is thrown away, and outpatients can be injected in a process that takes 30 minutes. They are observed for six hours and then sent home.”
In late July, the first patient was injected with the proposed treatment in a clinical trial in Germany being run in parallel with the US tests. As many as 12 patients will be injected, with a mix of smokers, diabetics and obese subjects to be tested in the US.
Phase I trials focus on safety. If the treatment is found to be safe, Phase II trials would begin. The US Food and Drug Administration granted Pluristem approval for the Phase I trials earlier this year.
The treatment is intended for victims of “late stage” ischemia who have not responded to other treatments or surgery and face the prospect of amputation. People selected for the trial will already have a condition related to ischemia, such as an ulcer or nerve pain.
All test patients will receive one injection and half will receive a second, Prather said. There will be no placebos. Pluristem will track both safety and efficacy data over a three-month period following the injections. Although the primary “end point,” or goal of the Phase I trial, is safety, Prather said doctors also will be able to track whether the patients show improvement.
“In animal trials, we saw improvement in blood flow in about three weeks,” Prather explained. “I’m not sure we can equate that to three weeks in humans, though. We could get efficacy in blood flow within a month or two months of injection.”
Even if the treatment proves safe and ultimately is granted FDA approval for sale, Prather pointed out the healing process would not be a quick one. “If these cells are going to be effective, blood flow improvement will be a matter of weeks and months, not inject today and improve tomorrow,” he said. “It just takes time for a new blood vessel to grow.”
Duke and Pluristem agreed to partner on the trial after Pluristem came in contact with Dr. Brian Annex, a former physician at Duke. “He is a world-renowned leader in angiogenesis (the growth of new blood vessels),” Prather said. “He was in transition at the time when we talked last year, and he recommended that we work with Dr. Kontos. Annex later joined the Pluristem Scientific Advisory Board.
“We are very excited about the possibilities,” said Kontos, who hopes for the first patient injections to be made by the end of August.

Wednesday, August 12, 2009

Peripheral Vascular Disease

There has to be knowledge in order to bring awareness...

From Wikipedia, the free encyclopedia

Peripheral vascular disease (PVD), also known as peripheral artery disease (PAD) or peripheral artery occlusive disease (PAOD), includes all diseases caused by the obstruction of large arteries in the arms and legs. PVD can result from atherosclerosis, inflammatory processes leading to stenosis, an embolism or thrombus formation. It causes either acute or chronic ischemia (lack of blood supply), typically of the legs.

Friday, August 7, 2009

Shammi Kapoor speaks about his battle with the little-known disease

By: Hemal Ashar Date: 2009-08-06 Place: Mumbai

Celebrities are notorious for keeping their guard up, not letting the world see that their star (literally) has dimmed, that they are human after all. So former star Shammi Kapoor deserves a double yahoo for letting his defences down and giving the world a peek into his frailties.

The actor was at the Breach Candy hospital on Tuesday afternoon, along with a clutch of doctors to raise awareness about peripheral vascular disease. The relatively little known disease occurs when there is a blockage of blood flow from the artery to organs other than the heart.

In familiar territory

The SoBo hospital is familiar territory for the actor, (also a kidney patient) who takes regular dialysis at the hospital. Shammi is also a Chronic Obstructive Pulmonary Disorder (COPD) sufferer, where his lungs have been compromised. He arrived in a wheelchair; and ribbed the docs at the press conference, "Ah, you all are wearing ties today." He then asked in jest, "What do you want me to talk about? The last time I winked at a girl? Okay, okay, I will tell you about my experience with vascular disease."

Lost toes

The flamboyant Kapoor was afflicted with the disease last year. He said, "I lost a toe on each of my feet to vascular disease. I was saved from losing my limbs by timely medical treatment." He then revealed how he heard the doctors who were operating on him in the operation theatre. "I was given local anaesthesia, so I could hear the docs speaking: "Here I found it, hey milaa vein, oh artery.

The pain was so bad, I started shrieking, an anaesthetist clamped my mouth shut." He said gesticulating wildly to laughter by the docs. The docs admitted that Shammi started bleeding while the operation was on and his thigh had swelled to twice the size, underlining the gravity of this disease.

Finally, Shammi when urged to give a message to mark Vascular Awareness Day on August 6, told people to take timely medical help, with the same flourish he delivered lines like Chahe koi mujhe jungli kahe on screen.

Monday, August 3, 2009

What is peripheral vascular disease?

Peripheral artery disease (PAD) is a heart condition similar to that of coronary artery disease and carotid artery disease. In PAD, the fatty deposits build up in the inner linings of the artery walls. These blockages restrict the blood flow circulation, mainly in arteries leading to the kidneys, stomach, arms, legs and feet.
In its early stages, a common symptom is cramping, or fatigue in the legs and buttocks during activity. Such cramping subsides when the person stands still. This is called “intermittent claudication.” People with PAD often have fatty buildup in the arteries of the heart and brain. Because of this association, most people with PAD have a higher risk of death from heart attack and stroke.
There are two types of these circulation disorders:
Functional peripheral vascular diseases don’t have an organic cause. They don’t involve defects in blood vessels’ structure. They’re usually short-term effects related to “spasm” that may come and go. Raynaud’s disease is an example. It can be triggered by cold temperatures, emotional stress, working with vibrating machinery or smoking.
Organic peripheral vascular diseases are caused by structural changes in the blood vessels, such as inflammation and tissue damage. Peripheral artery disease is an example. It’s caused by fatty buildups in arteries that block normal blood flow.
How is peripheral artery disease diagnosed and treated?
Techniques used to diagnose PAD include a medical history, physical exam, ultrasound, X-ray angiography and magnetic resonance imaging angiography (MRA).
Most people with PAD can be treated with lifestyle changes, medications or both. Lifestyle changes to lower your risk include stopping smoking, diabetes control and blood pressure. Become physically active; eat a low-saturated-fat, low-cholesterol diet.
PAD may require drug treatment, too. Drugs include medicines to help improve walking distance, antiplatelet agents and cholesterol-lowering agents (statins).