January 23, 2008 by

Dying Legs Treated with Human Stem Cells

With the hope of growing small blood vessels and restoring circulation in the legs, two patients were the first to be treated by transplanting a purified form of the subjects’ own adult stem cells into the leg muscles. Both patients suffered from severely blocked arteries and faced possible leg amputations. This first U.S. trial of the technique that has worked on laboratory animals was conducted by Northwestern University Feinberg School of Medicine.

“They’re at the end of the therapeutic road and they’re ultimately facing potential amputation,” said Douglas Losordo, M.D., the Eileen M. Foell Professor of Heart Research and principal national investigator for the study. “This is hopefully a way to help them avoid that.”

Losordo is director of the university’s Feinberg Cardiovascular Research Institute and director of cardiovascular regenerative medicine at Northwestern Memorial Hospital.

“The stem cells themselves can assemble into blood vessels,” Losordo said. “They can also secrete growth factors that stimulate and recruit other stem cells to come into the tissue and help with the repair. It’s an amazing biology we’re trying to leverage in these folks.”

The approach has proven to be effective in mice and rats during pre-clinical studies where stem cells were transplanted into the limbs of the animals.

“Based on that, we think it has a good chance of helping humans,” Losordo noted.

“This is a dreadful disease in which the profession has failed to offer much in the way of relief for these patients,” Losordo said. “We’re hoping this will have some impact.”

The trial is being conducted at 20 different sites nationally. The first two patients received their transplants at Northwestern Memorial Hospital.

Wounds that don’t heal, the breakdown of tissue, and gangrene can be the result of severely blocked arteries in the leg and sharply diminished blood flow. More than 100,000 limbs are amputated in the United States due to the painful condition call critical limb ischemia (CLI).

Affecting 1.4 million people, the emerging health problem is serious. By the time they reach the age of 70, and estimated 15 percent of the population will suffer from this disease.

Patients who have exhausted all other medical options including angioplasty, stents and bypass surgery to repair blocked circulation in their legs were the target of the Northwestern-led phase I/IIa study, which will include 75 people with CLI around the country.

Affecting about 10 million people in the United States, critical limb ischemia is the result of advanced peripheral artery disease. In peripheral artery disease, people develop blockages in their arteries and vessels that slow or stop the blood flow to their legs.

The condition is called CLI when they have wounds on their legs or feet that will not heal and pain at rest in their lower legs. If left untreated, CLI can result in a patient having toes, a foot or even a leg amputated.

People begin to experience pain when they walk, then when just sitting, as CLI progresses. Since blood flow decreases when people lie down, the pain is the worst at night. In order to lessen the pain and aid in blood flow, some even sleep in chairs.

“Peripheral artery disease is a big health problem,” Losordo said. “There is an emerging awareness of this disease on public health.”

The risk of developing the condition is elevated by high blood pressure, diabetes, high cholesterol and smoking.

However, Losordo points out that, “some people don’t smoke, have diabetes or high blood pressure and can still have blocked arteries in their legs.”
Losordo uses the subject’s own purified stem cells for the randomized, double blind, placebo-controlled trial. CD34+ stem cell from bone marrow are first released into the blood stream by a stem cell stimulating drug. The patient takes this drug for five days prior to the stem cell extraction. Then, the CD34+ enriched blood is obtained by way of an intravenous line that is inserted into a subject’s vein to collect blood through a machine that removes a population of blood cells. Losordo further selects and enriches the cells to select only CD34+ cells.

Filed Under: Heart Disease, News, Stem Cells, Uncategorized Tagged With: , , , ,
January 21, 2008 by

Heart Treatment with iPS Cells – Joint Japanese Research

In order to treat heart disease, induced pluripotent stem cells or iPS cells will be used in a joint study by two professors from Osaka and Kyoto university.

The joint research will be conducted by Osaka University Professor Yoshiki Sawa, who has treated heart disease using cell sheets created from muscle, and Kyoto University Professor Shinya Yamanaka, who created iPS cells that can develop into various types of cells, such as organ or tissue cells, from ordinary human skin.

Cardiac muscle regeneration treatment is the focus of their research.

Yamanaka will be the leader of a newly established iPS cell research center at Kyoto University. The announcement was made on Tuesday.

Using human thigh muscle, Sawa and his research team created cell sheets last year. The heart function of a patient who was a heart transplant candidate was improved when the cell sheets were attached to an area around the heart.

Sawa hopes to turn iPS cells into cardiac muscle cells since the cell sheets do not change into cardiac muscle. He hopes to apply the new research findings to the treatment.

Sawa said, “I’d like to create new cell sheets from new materials using iPS cells, make the sheets available in many cases and enhance the sheets’ practicality.”

The planned research center will be part of the Institute for Integrated Cell-Material Sciences, a world-class research institution that opened in October in Kyoto University.

Several institutions including Kyoto’s University’s Institute for Frontier Medical Sciences will help staff the center with several part-time teams of researchers. The center will also be comprised of a full-time team of 10 to 20 professors, associate professors, researchers and engineers.

The researchers are aiming to develop a safer method of creating iPS cells while sharing their research results. Studying technologies to turn iPS cells into cells for particular purposes is also on the agenda.

Yamanaka said at a press conference on Tuesday that he hoped the planned center would be a research facility open to researchers around the world covering basic to clinical medicine.

“I’d like to nurture young researchers because iPS research requires 10 to 20 years of effort,” he said.

A private incubation facility in Shimogyo Ward, Kyoto, will temporarily host the center in a research lab at the Kyoto Research Park.

Filed Under: Heart Disease, News, Stem Cells, Uncategorized Tagged With: , , , ,
January 20, 2008 by

Japanese Stem Cell Research Surges

With the intent of guiding Japan back to leadership in the field of biotechnology, the Koizumi government adopted a new strategy six years ago.

This did not mark the first time that a national policy initiative of this type was put into effect. And as the current administration tries to capitalize on an exciting stem cell breakthrough, Japan is on the verge of another.

Leading countries have surpassed Japan since 2002.

Japanese biotech drug development, as a ratio of overall drug development, lagged the US, Britain, France and Germany by about 50 per cent according to a report published last year by The Office of Pharmaceutical Industry Research.

Though it is generalization that doesn’t sit convincingly with the nation’s international scientific patents, or Nobel Prize winners over the past 20 years, the disappointing performance in applied biotechnology is often attributed to Japanese science’s alleged weakness at radical innovation.

However, it goes some way towards explaining the surge of official optimism that has built up behind Shinya Yamanaka’s induced pluripotent stem (iPS) cell research team at Kyoto University’s Institute of Frontier Medicine.

It remains to be demonstrated, however, that ministers and officials understand their contribution to previous shortcomings: ponderous and intrusive forms of regulation and administrative guidance that hobble Japanese scientists in the rapidly moving areas of medical and biological R&D.

In the late 1980’s, because of the countries excellence in science education, a high level of government commitment, and track record of converting research into commercial and clinical innovation, Japan was widely expected to become the dominant nation in the exciting new field of biotechnology even at senior policy levels in the US.

Intense bureaucratic supervision usually accompanies a high level of official commitment to an undertaking in Japan, and this is one reason why the biotechnology revolution did not take off in Japan as predicted.

Stem cell research programs can wait 12 months for government approvals, and once under way, pharmaceutical and biotech companies complain, grant-funded research is inflexibly administered.

Approval procedures are far lengthier than in the US and most other Western countries for new drugs and clinical procedures.

However, a fantastic door to opportunity for Japanese leadership has been opened by iPS cell research.

The Yamanaka team’s work seems to have signposted the path to the summit of biotechnology: stem cell therapy with its enormous promise to treat conditions such as Parkinson’s, diabetes, heart and spinal cord damage – but unencumbered by the ethical difficulty of using cloned human embryos or eggs to create embryonic stem cells.

The use of four genetic “transcription factors” to successfully reprogram mice skin cells into becoming stem cells was announced by Yamanaka in June. Another team from the University of Wisconsin was able to produce human iPS cells in November. Not long after, Yamanaka’s group succeeded in making iPS cells using only three transcription factors.

Since the gene c-myc can often cause tumors, they omitted it from the other four.

National admiration has risen for Yamanaka and the world’s attention as focused on the rush of innovation.

But almost invariably, a glum recitation of previous shortfalls in Japanese biotech comes out of what begins as news of further advances in the science or more government support for developing the technology.

The reason is not difficult to see.

Japan imposes the heaviest regulatory conditions of any country that permits embryonic stem cell research. So it is not difficult to at least partially understand why Yamanaka moved into iPS research.

He has complained about the Government’s “terrible regulations and crazy policies that crush any long-term projects”.

Other aspects of the iPS discovery have reached another breakthrough point said Yamanaka in an interview with Tokyo reports last week. However, stem cell therapy is still years away from clinical application he said.

“The other applications, like toxicology and drug development, it’s ready to go,” he said.

“We can use iPS cells in these applications today, if somebody can pay a lot of money – like pharmaceutical companies.”

Those applications involve using iPS cells to create, for instance, neural cells outside someone’s body so they can be tested for personal disease factors, or for an exactly tailored drug treatment.

An immediate start to

Filed Under: Heart Disease, News, Stem Cells, Uncategorized Tagged With: , , , ,
January 13, 2008 by

First BioArtificial Heart Created: Major Breakthrough Could End Donor Organ Shortage

An unprecedented feat that could signal the beginning of the end of organ shortages has been achieved by doctors who have stripped down and refurbished a dead heart so that it can beat again.

According to the American team, the shortage of replacement hearts and other organs could be overcome with the new research. The need for anti-rejection drugs could also be completely avoided.

The research, conducted by researchers at the University of Minnesota, could pave the way to a new treatment for the 22 million people worldwide who live with heart failure. The journal Nature Medicine described the the world’s first beating, retooled “bioartificial heart”.

To begin, cells were removed from a whole heart. The blood vessel structure, valves, chambers, and full architecture of the heart were left intact, and repopulated with new cells.

“We just took nature’s own building blocks to build a new organ,” says Dr. Harald Ott, a co-investigator who now works at Massachusetts General Hospital. “When we saw the first contractions we were speechless.”

The work has huge implications: “The idea would be to develop transplantable blood vessels or whole organs that are made from your own cells,” said Professor Doris Taylor, director of the Center for Cardiovascular Repair, Minnesota, principal investigator.

Virtually any organ with a blood supply could be created with the new method. The list includes the pancreas, lungs, kidneys, and liver.

Although costs make it prohibitive at present, Taylor is ready to grow a human heart. But she admits that the method is “years away” from being used in hospitals.

“We could begin with human cells and pig or human scaffold now but creating the larger bioreactors (the vessels in which the organs are grown) and generating the reagents and growing enough cells would cost tens of thousands of dollars for each heart at this point.”

“That is just too expensive to answer basic questions. We of course want to move in that direction, but funding is limited. As we can we will go forward – perhaps one heart at a time.”

Individuals face life long immunosuppression after an organ transplant. And over the long term, kidney failure, diabetes, and high blood pressure are the trade off for heart failure when using drugs to prevent rejection. Even getting to the point of performing the transplantation operation is difficult since donor organs are limited.

Researchers believe a new heart created by decellularization is much less likely to be rejected by the body since the heart is filled with the recipient’s own stem cells.

And once placed in the recipient, in theory the heart would be nourished, regulated, and regenerated similar to the heart that it replaced.

“We used immature heart cells in this version, as a proof of concept. We pretty much figured heart cells in a heart matrix had to work,” Professor Taylor says. “Going forward, our goal is to use a patient’s stem cells to build a new heart.”

As for the source of the cells from a heart patient, she says: “From muscle, bone marrow, or heart; depending on where the science leads us.”

Professor Taylor says that decellularization shows potential to change how scientists think about engineering any organ, even though heart repair was the initial goal.

“It opens a door to this notion that you can make any organ: kidney, liver, lung, pancreas – you name it and we hope we can make it,” she added.

According to UK Transplant, 81 people are waiting for heart transplant. Even though 28 patients died while waiting for a transplant last year, 155 patients had their lives saved or transformed by a heart transplant.

Typically, only 3,000 transplants are performed every year, despite more than 9,000 patients making up the waiting list nationally. While waiting, 1,000 people died last year.

A UK Transplant spokesman says: “These developments offer long term hope and long may they continue but the real problem now is a desperate shortage of donated hearts.”

Dr. Tim Chico, Consultant Cardiologist, University of Sheffield, says: “This is an ingenious step towards solving a massive problem. Heart failure (an inability of the heart to pump sufficient blood, usually after a heart attack) is increasing in the UK.”

“A chronic shortage of donors for heart transplantation makes stem cell therapy appealing. The study is very preliminary, but it does show that stem cells can regrow in the ‘skeleton’ of a donor heart. However, it will take a lot of further work to assess whether this will ever be a viable option for patients.”

Professor Wayne Morrison, Director of the Bernard O’Brien Institute of Microsurgery, Melbourne, comments: “This is the first time a whole organ has been tissue engineered outside the body.”

“They have demonstrated that they can create a heart that looks like a heart and is shaped like a heart and, most excitingly, that they can re-establish the blood vessels that were originally there. It is this ‘regrowth’ of the blood vessel cells that gives the potential in the future to connect this structure to a blood vessel in the body and then get circulation to go through it.”

“This very exciting study,” comments Dr. Jon Frampton, University of Birmingham. “Although this is only a first step requiring considerable follow-up development, the study nevertheless represents an exciting breakthrough that will eventually make the prospect of repairing damaged hearts a reality and will also be an approach that can be extended to other organs.”

Dr. Anita Thomas at the Australian Institute for Bioengineering and Nanotechnology, University of Queensland, adds: “There is one more major step to achieve before we can proceed any further: we need to see what happens when these artificial hearts are placed in a recipient animal for any length of time. The authors of the article have the necessary skills and yet have not reported their results. We wait with anticipation for their next publication.”

There have been advances in growing heart tissue in the laboratory but the complex architecture and intricacies of the body’s primary pump have to be mimicked exactly in order to be fully successful. Until now, the problem has been how to create a 3D scaffold that could do this.

This is why “decellulariazation” became the method of choice for Professor Doris Taylor and her colleagues. The process leaves only the extracellular matrix, the framework between the cells, intact, along with the plumbing and heart valves. This is accomplished by using a detergent to remove all the cells from the organ – in this case, an animal cadaver heart.

Taking immature cells that came from newborn rat hearts, researchers injected rat hearts with this mixture and placed the structure in a sterile chamber in the lab to grow. This was done after first removing the cells from both rat and pig hearts using a detergent.

Professor Taylor said the results were very promising. Contractions were observed in the hearts four days after seeding the decellularized heart scaffolds with cells. Even though it was only at two percent of the efficiency of an adult heart, the hearts were pumping eight days later.

A study at of the hearts at the cellular level revealed that the “cells have many of the markers we associate with the heart and seem to know how to behave like heart tissue.”

Filed Under: Heart Failure, News, Stem Cell Research, Stem Cells, Uncategorized Tagged With: , , , ,
January 12, 2008 by

Heart Failure Treatment with Adult Stem Cells

For many patients who have run out of options, a new treatment could offer new hope.

The treatment is for patients who have had stents, surgeries, and other treatments without success. These patients suffer from severe coronary artery disease and are at great risk for heart attacks and progressive heart failure.

An injection of stem cells being tested by doctors at Chicago’s Rush University Medical Center with the hope that it will alleviate the problems patients have with their hearts.

Medical history may be made by James Campbell. The sixty-eight year old heart patient has volunteered to have an injection administered directly into his heart. The injection will be blind, meaning that he could possibly be injected with a placebo. But hopefully, the injection will be a special type of stem cell. Campbell is participating in a clinical trial to see if new blood vessels can be grown with stem cells.

“If it works, it’s worth it,” Campbell said.

“The hope is that these endothelial progenitor cells will grow and divide and allow and facilitate new blood vessels to enter that region of the heart muscle that’s not getting enough blood and oxygen,” said Dr. Gary Schaer, director of cardiac catherization at Rush.

Campbell wants to end the debilitating and chronic chest pain he has suffered for three years. He has survived through a heart attack and two heart surgeries already.

“I can walk maybe 60 to 65 feet and I start having chest pains,” Campbell said.

The day before the injection, Campbell donated his own stem cells like every other patient also enrolled in the trial.

“The advantage of the patient’s own stem cells is there’s no chance of rejection,” Schaer said.

Dr. Schaer says the no ethical issues come into play for this treatment. Several dozen patients like Campbell have been injected by Dr. Schaer using 3-D computer mapping and sophisticated catheter technology since the trial started. The results have been incredibly encouraging and there have been no adverse reactions.

“The patients that we’re seeing in follow up, and we’ve seen several that have come back for their one year follow up, we’ve seen marked improvements in their symptoms,” Schaer said.

The current trial is still recruiting patients. But Rush Medical has more trials planned, with different diseases and different kinds of stem cells.

Some of Campbell’s hobbies prior to his heart problems were riding motorcycles and canoing. He is hoping that the injections will alleviate his pain, and allow him to go back to a normal life where he can be active again.

Filed Under: Heart Failure, News, Stem Cell Research, Stem Cells, Uncategorized Tagged With: , , , ,
January 11, 2008 by

Stem Cells for Spinal Cord Injury

A 38-year old woman has been treated for spinal cord injuries using stem cell therapy. K G Hospital treated and cured a heart patient with stem cell therapy previous to the woman’s treatment as well.

On Friday, Dr. G. Bhaktavasalam, Chairman, K G Hospital, told reporters that after a road accident, the woman suffered paralysis below the neck and lost movement in her limbs due to spinal cord injury.

With a fracture of the neck bone, she was diagnosed with a

Filed Under: News, Spinal Cord Injury, Stem Cell Research, Stem Cells, Uncategorized Tagged With: , , , ,
January 9, 2008 by

Stem Cell Bank Proposed by Japanese Researcher

On Wednesday, a Japanese researcher proposed a system that could help reduce the time and money needed for treating patients with regenerative medicine in the future. A new type of stem cell, which is produced from a donor’s ordinary skin cells, would be banked much like umbilical cord blood is today.

Shinya Yamanaka of Kyoto University said that instead of tailor-made treatments for individual patients, the proposed system would be more practical.

In November of 2007, without using human embryos or cloning technology, Yamanaka led one of two teams which were able to transform ordinary human skin cells into cells that look and act like embryonic stem cells.

Ethical debates have swarmed stem cell research for years, but Yamanaka’s Japanese based team, along with another team from the United States quited many by reporting their research last year.

Even though researchers say it will take years before such medicine can be used to treat people, new hopes for regenerative medicine have been kindled by the new type of cell called the induced pluripotent stem cell (iPS cell).

“It may be a good idea to make an iPS cell bank,” Yamanaka told a news conference.

“By making such a bank, we can cut down the cost of treatment and also we can shorten the period which is required for the generation of iPS cells,” he said.

“In reality, tailor-made medicine using iPS cells is not so ideal.”

The way to treating people with injuries as well as diseases like diabetes, Alzheimer’s, and heart disease may be paved with iPS cells. Scientists expect them to improve disease research considerably.

However, cells may be needed within 10 days to treat a spinal cord injury and Yamanaka said it takes about three months to transform a patient’s skin cells into iPS cells. The lag in time is the reason for the banking proposal.

Before iPS cells can be used to treat humans, more testing is needed. Although he expects iPS cells to be clinically useful within ten years, it could be longer before iPS cells are used to treat some of the more challenging diseases said Yamanaka.

Filed Under: News, Spinal Cord Injury, Stem Cell Research, Stem Cells, Uncategorized Tagged With: , , , ,
January 5, 2008 by

Tremendous Progress with Adult Stem Cells in 2007

The FDA approved clinical trials for adult stem cells to the tune of 1100 in 2006. But 2007 was even more successful for adult stem cells. Over 1400 FDA approved trials for 73 different conditions in humans where patient health has been improved through adult stem cell therapy were documented in peer-reviewed studies in 2007.

Umbilical cord blood, placentas, and other tissues in the body contain adult stem cells. They are found throughout the entire body. No embryos are destroyed when extracting adult stem cells, which is in contrast with the extraction of embryonic stem cells.

We have decided to publish a yearly update each fall/winter since treatments with adult stem cells are continually increasing and continue to be impressive. (Note: Embryonic stem cells have never produced successful treatment trials in humans.)

Adult stem cells do not create tumors, unlike embryonic stem cells.

The research and treatments involving adult stem cells has been fast paced since our 2006 paper, thus, we have summarized some of the developments in the field below.

The Regeneration of Heart Tissue

Eight years ago, Doug Rice was diagnosed with congestive heart failure. Due to his diabetes, he was unable to get a heart transplant.

Rice decided to travel offshore for adult stem cell treatment since he was facing fatal heart failure. Stem cells were extracted from a sample of blood taken from Rice. The cells were differentiated into angiogenic cell precursors, then transplanted into Rice’s heart.

The results were immediate for Rice, who experienced an increase in his hearts efficiency of 30 percent. He originally had an ejection fraction of 11 percent.

According to Rice, “I’ve been around a lot of people with bad hearts. I know if they looked at [adult stem cell therapy], it might save their lives. I firmly believe it saved mine.”

A few other companies have developed adult stem cell technology for heart patients.

Marc Penn, director of the Bakken Heart Brain Institute at the Cleveland Clinic, says of one new therapy, “It’s very exciting, perhaps a sea-changing trial for the field … offering the chance of an off-the-shelf-product.”

Bone marrow stem cells have been used by Bodo-Eckehard Strauer to treat over 300 heart patients. He is the director of the cardiology department at Dusseldorf University Hospital. A patient who was

Filed Under: Heart Failure, News, Stem Cell Research, Stem Cells, Uncategorized Tagged With: , , , ,
January 2, 2008 by

MS Patient Improves Following Adult Stem Cell Treatment

Without the ability to even walk a short distance, Cathy Zuker suffered from Multiple Sclerosis for 27 years. Her condition had progressed to an absolute worse case scenario.

Before she got a stem cell transplant, she had to lift her legs manually when she got into the car. Her left leg would drag behind her when she walked. Her condition started improving after a stem cell transplant on May 21st, 2007. She began to notice a difference in her legs on the 24th. She said her legs started to feel lighter on the 25th, and considered her improvement to be amazing. On June 7th, 2007, she was able to not only move her legs but could get into a car without any help. Not only that, but her energy returned as well.

According to her,

Filed Under: Adult Stem Cells, Multiple Sclerosis, News, Stem Cell Research, Stem Cells, Uncategorized Tagged With: , , , , , ,
January 1, 2008 by

Non-Profit Public Stem Cell Bank Opens in Chennai

Providing high quality stem cells for treatment, a Public Stem Cell Bank will be established in Chennai by the non-profit Jeevan Blood Bank company.

On Thursday, Dr. P. Srinivasan, Chairman, told reporters that about 40,000 units of stem cells collected from cord blood would be collected, processed and stored by the stem cell bank in five years. The project is set to go live before the end of March 2008.

Blood cancers, heart disease, autism, and more than 70 other medical conditions can be treated and potentially cured by stem cells. It is one of the best treatment options available today.

Srinivasan said the bank plans to collect cord blood from donors, harvest stem cells, test for transmissible infections, store and ultimately release the safe compatible units to any one who needs them across the world.

By December of 2008, completion if accreditation processes by international agencies is planned for the Jeevan Stem Cell Bank.

Private storage at the bank will be fee based. The funding would then be applied to the public side of the bank in order to pay for those services. 30 percent of the available storage has been reserved for private banking, while the other 70 percent is reserved for public storage.

So that matching units of cord blood can be identified by any hospitals across India as well as the world, the bank plans to publish the contents of a stem cell registry online in the next 12 weeks. When a suitable unit of stem cell was available, it would be transported frozen to the hospital where the patient was admitted for transplantation, he said.

By April 2009, the facility will be moved to a permanent 25,000 square feet location. In the meantime, it will operate on rental premises said Srinivasan.

Filed Under: Autism, News, Stem Cell Research, Stem Cells, Uncategorized Tagged With: , , , ,
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