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Adult Stem Cells Improve Cardiac Function in Angina Patients

Friday, July 8th, 2011

CHICAGO & DEERFIELD, Ill., Jul 07, 2011 (BUSINESS WIRE) — New research published online today in Circulation Research found that injections of adult patients’ own CD34+ stem cells reduced reports of angina episodes and improved exercise tolerance time in patients with chronic, severe refractory angina (severe chest discomfort that did not respond to other therapeutic options).

The phase II prospective, double-blind, randomized, controlled clinical trial was conducted at 26 centers in the United States, and is part of a long-term collaboration between researchers at Northwestern University Feinberg School of Medicine and Baxter International Inc. The objective of the trial was to determine whether delivery of autologous (meaning one’s own) CD34+ stem cells directly into multiple targeted sites in the heart might reduce the frequency of angina episodes in patients suffering from chronic severe refractory angina, under the hypothesis that CD34+ stem cells may be involved in the creation of new blood vessels and increase tissue perfusion.

“Early research across multiple disease categories suggests that stem cells generated within the body in adults may have therapeutic benefit. This is the first controlled trial treating chronic myocardial ischemia (CMI) patients with their own stem cells to achieve significant reductions in angina frequency and improvement in exercise tolerance,” said lead investigator Douglas W. Losordo, MD, director, Feinberg Cardiovascular Research Institute and the Eileen M. Foell Professor of Heart Research at Northwestern’s Feinberg School of Medicine and director, Program in Cardiovascular Regenerative Medicine at Northwestern Memorial Hospital. “While we need to validate these results in phase III studies before definitive conclusions can be drawn, we believe this is an important milestone in considering whether the body’s own stem cells may one day be used to treat chronic cardiovascular conditions.”

The research team mobilized and extracted stem cells from all participants before randomizing them to one of three treatment groups: low or high-dose cell concentrations, or placebo, and administered the regimens in 10 distinct sites in the heart tissue through a multi-point injection catheter.

At six months after treatment, patients in the low-dose treatment group reported significantly fewer episodes of angina than patients in the control group (6.8 vs. 10.9 episodes per week), and maintained lower episodes at one year after treatment (6.3 vs. 11 episodes per week). Additionally, the low-dose treatment group was able to exercise (on a treadmill) significantly longer at six months after treatment, as compared with those in the control group (139 seconds vs. 69 seconds, on average). Angina episodes and exercise tolerance rates were also improved in the high-dose treated group at six months and at one year post treatment compared to the control group (the placebo group).

“The concept of using one’s own stem cells to treat disease is highly attractive to the medical community and this research is consistent with Baxter’s commitment to driving scientific advances that can lead to promising new treatments for critically ill patients,” said Norbert Riedel, Ph.D., Baxter’s chief scientific officer. “These results provide important insights into the potential for these cells to be used in larger scale settings, and we look forward to moving into phase III studies in the near future to hopefully substantiate these results.”

When comparing major adverse cardiac events, there was no evidence of complications related to the autologous stem cells. Three deaths occurred during the trial, one from procedural complications due to the inherent risks of cardiac surgery, the others unrelated to the treatment (all in the control placebo group). Myocardial infarction (MI or heart attack) occurred in seven of the control group patients. There were three MIs each in the low-dose and high-dose patient groups.

Previous preclinical studies of autologous CD34+ stem cells have shown an increase in capillary density and improved cardiac function in models of acute and chronic myocardial ischemia. This phase II study is based on a phase I/II study, which provided early evidence of the feasibility, safety and bioactivity of these autologous stem cells in a similar setting.

Angina is characterized as chest discomfort due to a lack of sufficient blood supply to the heart associated with obstructive coronary artery disease (CAD). More than 850,000 patients in the United States experience refractory angina that has not responded to other therapeutic options, according to current estimates. This leads patients to reduce their activity levels significantly and negatively impacts their quality of life.

About Northwestern Memorial Hospital

Northwestern Memorial is one of the country’s premier academic medical center hospitals and is the primary teaching hospital of the Northwestern University Feinberg School of Medicine. Along with its Prentice Women’s Hospital and Stone Institute of Psychiatry, the hospital comprises 854 beds, 1,603 affiliated physicians and 7,144 employees. Northwestern Memorial is recognized for providing exemplary patient care and state-of-the art advancements in the areas of cardiovascular care; women’s health; oncology; neurology and neurosurgery; solid organ and soft tissue transplants and orthopaedics.

Northwestern Memorial possesses nursing Magnet Status, the nation’s highest recognition for patient care and nursing excellence. It is also listed in 12 clinical specialties in U.S. News & World Report’s 2010 “America’s Best Hospitals” guide and ranks No. 1 in Chicago in the 2010 U.S. News & World Report Best Hospitals metro area rankings. For 10 years running, Northwestern Memorial has been rated among the “100 Best Companies for Working Mothers” guide by Working Mother magazine. The hospital is a recipient of the prestigious National Quality Health Care Award and has been chosen by Chicagoans as the Consumer Choice according to the National Research Corporation’s annual survey for 11 years.

About Northwestern University

Northwestern University Feinberg School of Medicine, founded in 1859, attracts talented individuals to its faculty, staff, and student body through its cutting-edge research initiatives, superb clinical facilities, global outlook, and innovative curriculum. Consistently ranked high on the list of best research medical schools, Feinberg is part of the vibrant educational and cultural community of Northwestern University, an independent private institution founded in 1851, and is a central component of a premier academic medical center, Northwestern Medicine.

Located on the Northwestern campus in the heart of Chicago’s Magnificent Mile, Feinberg has built a national reputation for excellence through a strong history of collaborative, interdisciplinary medical education and research. Feinberg’s top-rated clinical affiliates include Northwestern Memorial HealthCare, the Rehabilitation Institute of Chicago, Children’s Memorial Hospital, the Jesse Brown VA Medical Center, the Northwestern Medical Faculty Foundation, as well as numerous hospitals and clinics across the region. To learn more, visit www.feinberg.northwestern.edu.

About Baxter

Baxter International Inc. through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the use of adult autologous stem cells to treat chronic myocardial ischemia (CMI), including Baxter’s expectations with respect to additional phase III studies. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: timely submission and approval of anticipated regulatory filings; the successful initiation and completion of required Phase III studies; additional clinical results validating the use of adult autologous stem cells to treat chronic cardiovascular conditions; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; and other risks identified in Baxter’s most recent filing on Form 10-K and other SEC filings, all of which are available on the company’s website. Baxter does not undertake to update its forward-looking statements.

 

SOURCE: Baxter International Inc.  Research by Northwestern University and Baxter Published in Circulation Research Finds Improvement in Rates of Severe Chest Pain and Exercise Tolerance

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Posted in adult stem cells, stem cell facts, stem cell news, stem cell therapies, Stem Cell Worx, stemcellworx | 10 Comments »

Stem Cell Therapy – An Inspiring Story

Tuesday, May 10th, 2011

Stem Cell Therapy - An Inspiring Story by Udayan Patel Pictured Above

Udayan Patel, 66, from Mumbai, India is an eminent psycho-therapist, who was diagnosed with idiopathic pulmonary fibrosis in 2009.

His doctor’s verdict was unambiguous stating “it’s a nasty disease that debilitates the body and severely curtails lifespan.”

Here, in Udayan’s own words, he describes the after-effects of the prognosis and how his desperate search for help and hope led him to stem cell therapy. Read Udayan’s inspirational story below.

The nasty dry cough had prolonged unreasonably, defeating various medication. After several months, spanning seasons, I began to feel that there was something very wrong with my lungs. I had started smoking while still at school, continued through college and adult life, stopping only at the age of 52. Though I’ve had five bypass surgeries, as an ex-smoker one always has to be ready for the judgement of consequences.
 
So I referred myself to Dr Farokh Udwadia. He examined me; he heard the sound of my lungs and, even as I lay on the examining table, he silently walked away to stand behind his desk where he extended his arms and gave his stethoscope a satisfied stretch. It was the confident gesture of a good diagnostician: he’d figured out what was wrong with me.

He prescribed a battery of tests: blood work, chest scan, lungs function test which he wanted me to do immediately. I was diagnosed with idiopathic pulmonary fibrosis-my lungs were packing up on me, and there was no known cause, hence idiopathic.

“It’s a nasty disease, Udayan,” Udwadia told me bluntly. I was put on cortisones but also told that in this disease nothing really works. My cough wouldn’t go. From the way Dr Udwadia spoke, I understood that my day-to-day life was going to be severely curtailed. Already, within days of the diagnosis, walking had become a strain. This was March 2009.    

My oxygen levels started dipping, posing danger to both head and heart. I now kept an oxometer and monitored my levels periodically. In November of that year I went for a holiday to Mahabaleshwar. There, I found myself unable to walk, I felt a great unease and was alarmed because never in my life have I felt such extreme fatigue. I cut short the holiday and drove back and went straight to my doctor.
 
By this time I was referring with Dr Pratibha Singhal at Bombay Hospital. She upped the cortisone dose and put me on oxygen. I felt such overwhelming relief the moment I was given oxygen that I have had no qualms about being on oxygen 24 by 7 since. There seemed no point in resisting it.

Despite that my life slowly began coming to a standstill. Everything became an effort. All around me I saw people running, walking, being active… This had become my past. I became conscious of each measure of time.

There were other changes too. I like my drink, but because of the heavy medication and my body already struggling, there was the danger of damaging my liver. I was told I could have 60 ml of alcohol a week. I divided it into six days. Measuring my pleasures in coffee-spoons.       

I told my doctor I wanted to read up everything that was available on the disease. I wanted to know what restriction were coming and how much time I had left. She gave me a book by an Indian doctor based in the US, Dr Ganesh Raghu. I found out that statistically I had two to five years left. Every dark cloud was mentioned in the book. I was very impressed by his way of thinking and I tracked him to Seattle.

A lung transplant was suggested but that would mean I’d have to live abroad for the next three to four years, primarily because of the cleaner air there. This did not seem like a genuine option to me as my work was here. I began to read more case studies and discovered there was no real hope. It seemed I may not have very long.

To cope with the constant awareness of a limited lifespan is difficult. I started having intense memory experiences. I’d wake up most mornings from vivid dreams which would evoke a certain memory set. It could be a face, a colour, even a particular light! The more restricted my physical life became, the more vivid the life of my mind got.

I had thoughts like, Would I ever see another city; would I get to see the sea link extended to Nariman Point.  There was a ceaseless review of my life going on in my head, the dark errors, the people I had hurt deeply, the knowledge of how shallow and impulsive I had been…Those days were difficult.

I felt a curtain of darkness descend round me that separated me from the rest of the world. I wanted to talk about what was happening to me but who would want to listen? I could see how anxious my wife and daughter already were and I debated how much of my emotional problem to share with them.    

Then two things happened, almost simultaneously. In 2010, I went to the US, with the aim of meeting Dr Raghu in Seattle. I broke my journey in Boston. In the US, through friends, I met another patient of idiopathic pulmonary fibrosis. He was confined to a room, surrounded by rows of oxygen cylinders. It was a bleak and terrifying image of complete paralysis.

I decided to abandon the idea of conventional medicine-it offered little hope anyway. I cancelled my trip to Seattle and instead, I went to Harvard. My friend, the scholar Homi K Bhabha, put me in touch with Dr Douglas Melton there who is doing research in stem cells. He has a fascinating mind. While his research does not involve humans, he convinced me stem cells would not harm me.

After all it’s our cells that create the body in the womb, organ by organ. Instead of looking for quantifiable data, I put faith in the scientific idea that the body has the knowledge to regenerate. I also felt that stuff taken out from my body and injected back could not have an adverse impact as it was not something foreign being introduced.

I returned to Mumbai and approached Kasiak Regenerative Cellutions which conducts stem cell research. My wife and I had already met the scientist there, Vijay Sharma, and we agreed to put me through stem cell therapy. 

Stem cells drawn from my body are treated and injected back every month. Initially the regeneration manifest itself in my skin, the wrinkles faded, the tone improved, then gradually my oxygen levels improved. While earlier, at rest, my oxygen level was 89-90 per cent, it has now gone up to 95-97 per cent.

For a man gasping for every ion, that’s a big improvement. Armed with a mobile battery-operated oxygen pack, I can walk on the treadmill, I can swim a few lengths and walk 170 meters without panting. I can work for a full day, travel, go to music concerts of longer duration. You’ll usually find me in the last row of the auditorium, my oxygen tower plugged in a socket somewhere in the wall. My various other parameters too have stabilised.

With the oxygen levels improving, my mood also began to lift and I could be more attentive to minute shifts. I re-read the psychoanalyst Meltzer who said attention is love. This idea which I had known, began to acquire a new life. Attention, observation and trust are the fundamentals of my life. I realized if I developed patience with whatever I was feeling, and yet was attentive to all that was going around me, I’d be able to live a quiet life.

 

As published on: http://www.ahmedabadmirror.com 

Posted in pulmonary fibrosis, stem cell therapy, Stem Cell Worx, stemcellworx | 10 Comments »

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