Marco Costa, MD, PhD, Director, Interventional Cardiovascular Center and Research & Innovation Center, UH Case Medical Center, reports there are two methods for obtaining the stem cells. “One way is to give the patients granulocyte stimulating factor,” Dr. Costa said. “This increases the number of stem cells in the blood, and then we can collect a large number of these cells by apheresis, the process of removing a specific component from blood and returning the remaining components to the donor, in order to collect more of one particular part of the blood than could be separated from a unit of whole blood. The alternative, and the method we prefer, is to obtain a small number of cells from the patient’s blood and expand them for seven days in culture media, which is a kind of ‘health spa’ for the cells.” “Because of our ability to add cytokines and growth factors to control the growth environment,” Dr. Costa said, “these cells are healthier than those in the original cell population derived from patients with advanced diseases.”

“Patients who come to UH Case Medical Center will find that they have many treatment options,” he said. “Some may benefit from other procedures that we already offer. If they meet inclusion criteria, however, some patients could be recruited to participate in stem cell trials that are actively enrolling patients or in exciting upcoming clinical trials.”

“We believe that there is merit to this approach, we just want to see it (carried out) well, ethically and rigorously,” said Dr. Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami’s Miller School of Medicine. Scientists like Hare are “trying to gather medical evidence through clinical trials to ensure that these treatments are safe and effective.”

Leaving the country to seek experimental treatments abroad is common, experts say. “Medical tourism as an industry is projected to grow 35% annually, and could reach 1.6 million American patients going elsewhere for treatments by 2012, according to the Deloitte Center for Health Solutions. (The agency had previously predicted 6 million by 2010, but those numbers have not panned out.)”

Another concern is that, “without proper regulation, any given stem cell therapy abroad may actually be different every time you receive a treatment,” said Jeffrey Karp, director of the Laboratory for Advanced Biomaterials and Stem-Cell-Based Therapeutics at Brigham & Women’s Hospital in Cambridge, Massachusetts. “There also may not be any regulations on the quality of the treatment, so you really don’t know what you’re getting,” he said.

“Regulatory agencies such as the FDA can ensure that cell therapy that reaches patients is safe, effective, and that quality control is established for isolating the cells, manipulating them outside of the body, and delivering them,” Karp said.

“While stem cell treatments have been shown to have significant placebo effects during controlled clinical trials, I think patients considering unregulated stem cell treatments need to be aware that they are not optimized and may even do harm,” he said.

Oliver Ryder, director of genetics at the San Diego Zoo and co-leader of the study, contacted Jeanne Loring, professor of Developmental Neurobiology Jeanne Loring at the Scripps Institute, about “the possibility of using the tissue-sample bank to generate and store stem cells.” Researchers from the Scripps Institute detail their work in the online September 4 edition of the journal Nature Methods.

“Stem cell technology provides some level of hope that they won’t have to become extinct even though they have been completely eliminated from their habitat,” Ryder said.

“We are the first to take this method forward to extinct species,” says Dr. Ben-Nun. “We hope that in the not-so-distant future, it will be able to create new individuals of the same species.” “The idea itself is interesting, but many years may pass until it can be implemented,” says Prof. Joseph Itskovitz-Eldor of the Technion’s medicine faculty, who took part in the first experiment to produce human stem cells.

“Even if an egg and sperm cell can be produced from stem cells,” he added, “it is not easy to fertilize them. It’s like in vitro fertilization and each animal needs specific conditions for that. However, the biotechnological development is so rapid that what seemed imaginary a decade ago is already happening. There are always surprises.”

Ben-Nun agrees. “It won’t happen tomorrow, but it could happen sooner than we think. Our research’s goal is to show that it can work and we want to bring that to the attention of the people dealing with preserving species and stem cells,” she said.

The trial “will test the safety of using replacement retinal cells, which are the body’s master cells, the source of all other cells, known as retinal pigment epithelial cells, derived from human embryonic stem cells.”

Proponents of the treatment say “they could transform medicine, providing treatments for blindness, juvenile diabetes or severe injuries. Although, opponents dislike the study because to get the cells, someone would have to take apart a human embryo.”

Massachusetts-based ACT will start the trial of its treatment, which uses retinal pigment epithelium derived from human embryonic stem cells, on 12 patients in Britain with a disease called Stargardt’s macular dystrophy.

“This is another important milestone for ACT and for the field of regenerative medicine,” Gary Rabin, chairman and chief executive of ACT, said in a statement.

This is “the first clinical trial of human embryonic stem cells to be approved anywhere in Europe. ACT and another U.S. firm Geron Corp won the first licenses last year for similar trials in the United States in people with Stargardt’s and people with spinal cord injuries.”

“When you see companies like Pfizer, GSK [GlaxoSmithKline], Johnson & Johnson and GE invest in stem cells and regenerative medicine, it suggests a level of maturity. It is still high risk, but it is a calculated risk,” he says. Minger, who made the switch from a high-profile academician as director of the Stem Cell Biology Lab at Kings College, London, to the global head of Research & Development (R&D) for cell technologies at GE Healthcare, justifies his move as one for enabling cellular therapy. “I still do what I have done all my life ­- grow cells.

“My model is Devi Shetty [cardiac surgeon and promoter of Narayana Hrudalaya Hospitals], providing first world treatment at third world prices,” he says. Minger has been visiting India regularly and is aware that “cellular therapy is not new here”. “Balu [D. Balasubramanian, director of research at LV Prasad Eye Institute in Hyderabad] is my idol. His hospital has treated more than 3 million patients in five years, and mostly free,” he says. Initially, though, the cost of cellular technology will be high, “we will bring it down,” says Minger.

“You can’t even imagine how risk-averse I am. I have grown cells for 20 years and never put them in humans, but now I see the results. I have 32 projects worldwide; I monitor them every week and I closely follow the thought leaders in the field,” says Minger.

“Injecting a type of fat cell stimulated hair growth in mice which otherwise struggled to grow hair.” The Yale University team says “it may be possible to use the findings to one day restart hair growth to reverse balding.” They said there was “a four-fold increase in the number of ‘precursor’ fat cells in the skin around a hair follicle when it started to grow.”

They looked at “defective mice which could not produce these fat cells. Hair normally grows in cycles, but in the defective mice – the follicles had become trapped in the dormant phase of the cycle. Scientists injected fat cells from healthy mice into the defective mice. Two weeks later, hair follicles had started to grow.” The study proposed: “That [fat] precursor cells secrete platelet-derived growth factor to promote hair growth.”

Prof Valerie Horsley, from Yale University, said: “If we can get these fat cells in the skin to talk to the dormant stem cells at the base of hair follicles, we might be able to get hair to grow again.” The study suggested the fat cells could have other functions involving stem cells such as tumour formation or healing wounds.

Dr. Adler’s research is at the cutting edge of the stem cell field and we are thrilled that he has joined Americord to help us advance the means by which stem cells can be preserved for future medical treatment,” said Americord Registry President and CEO Martin Smithmyer. “His work opens up new avenues for us to explore and enables us to stay abreast of the most current research, which is consistently and increasingly finding new therapeutic uses for stem cells.” Dr. Adler’s research is funded by the National Institute of Health and the American College of Cardiology and has focused on the use of pluripotent stem cells for the study and treatment of cardiovascular disease. His research has been featured in publications in the world’s top scientific journals, including the June 2010 cover of Nature. He is currently Medical Director of Cardiac Transplantation and Associate Professor of Medicine at University of California, San Diego. Previously, Dr. Adler was a cardiologist and stem cell researcher at Mount Sinai Hospital in New York. Dr. Adler is a graduate of Northwestern University, where he received his B.A. in English, and Boston University, where he received his Doctorate of Medicine. “Researchers are getting closer every day to developing groundbreaking treatments using pluripotent stem cells. Preserving stem cells that are genetically closely matched to the patient will become critically important to address the real challenge of transplant rejection,” Dr. Adler said. “Americord intends to be at the forefront of the collection and preservation of stem cells that can substantially minimize transplant rejection and improve survival rates and we are one of the few cord blood banks dedicating resources towards this research.”

Umbilical cord blood and tissue are harvested from new-born babies and stored . “It’s a choice between using umbilical cord cells or bone marrow…. Something that would be discarded as waste versus an invasive procedure,” said Terence Gregory, CEO of John Daniel Holdings, the parent company of Lazaron Biotechnologies. “We also offer an international storage option, as well as a dual option,” he said. “The South African industry is young…. Cryo-Save International has supplied 18 samples that have been used successfully in SA.”

The main problem in the industry, said Michael Pepper, an extraordinary professor in the Department of Immunology at the University of Pretoria, and Nicolas Novitzky, head of haematology at the University of Cape Town, was the absence of regulations. “Regrettably in SA, we’re working in a legislative vacuum. There is no legislation covering stem cells. Laboratories that store cord blood stem cells are not locally accredited…. They might be of international standard, but we don’t know,” Prof. Pepper said.

“I hope the amalgamation (of Lazaron and Cryo-Save ) adheres to the right quality-control standards and correct techniques. Previously this might not have been the case.” Gregory said the company was keen for the regulations to come in sooner rather than later, and that the new facilities adhered to international standards. Pepper highlighted the importance of consumer education. “You have to look past the hype and the excitement and the marketing techniques used. You need to make sure the cells stored will be of use to the family. Every pregnant mother and expectant father wants to do the best for their children … (and) you have to be careful not to exploit emotionally vulnerable people with services that are marketed as successful,” he said.

Novitzky was dismissive of private stem cell storage. “There’s a principle which is wrong. The chance of using ( it) is extremely low. The standard is 1 in 85000 from the largest … bank in California. It is not cost-effective. We need a public bank to cater for all the needs of society — those not represented in international registries, such as indigenous Africans. If you start looking at world trends, the paediatric and obstetrics societies do not favour it.”

However, he also likened saving a baby’s umbilical cord stem cells to life insurance. “Our figures show that your child’s likelihood of using stem cells for cancer is 1000 to one — long odds, but the same as life insurance.”

“It’s a process where the blood is obtained after the baby is delivered, The umbilical cord has been clamped and cut and the baby has been passed off to the nurses caring for the baby. That’s when we obtain the blood. It’s sitting in the umbilical cord and we’re waiting for the placenta to deliver, and it’s nothing more than putting a needle into the vessel and getting the blood to drain,” said Dr. Gerald Zarlengo, director of Women’s and Children’s Services at St. Joseph’s Hospital. St. Joseph’s Hospital is one of two metro-area hospitals that have been part of the university’s public cord blood banking program for the past few years.

“We didn’t know anything about it at all. We came to the class expecting to walk around the hospital and see what we were getting ourselves into, and then they gave this option to us of donating and helping someone else out in the process of receiving our blessing,” said new father, Mike Williams.”Mike’s niece had actually passed away in April of this year from leukemia,” added Mike’s wife, Soraya.

“(To donate) was an easy decision for me. It doesn’t cost anything. It’s helping somebody else for nothing.”Umbilical cord blood is special because it’s full of an abundance of hematopoietic, or blood-forming, stem cells, according to Kuenne. It has similar properties as bone marrow, but it’s much easier to obtain. It’s also easier to find a match, Kuenne said, because a baby’s immune system isn’t fully mature.

“There’s a lot of research going on right now, because it is new, and there’s a lot of potential disorders that it could treat, like maybe cerebral palsy and Type 1 diabetes,” said Kuenne.

The study is led by William G. Wierda, M.D., Ph.D., Associate Professor of Medicine, Leukemia Department, Division of Cancer Medicine, and is based on translational work published by a group led by William Plunkett, Ph.D., Professor and Deputy Chair, Department of Experimental Therapeutics, both of MD Anderson. The trial is being funded by MD Anderson’s Leukemia Department with Cyclacel contributing sapacitabine and a small grant to support the performance of certain exploratory diagnostic tests. “As gene-based, personalized medicine approaches have in certain cases been developed and approved faster than traditional methods, we are encouraged by the prospect of tailoring treatment with sapacitabine to the genetic profile of an individual’s cancer cells,” said Spiro Rombotis, President and CEO of Cyclacel. “We have collaborated with Dr. Wierda, Dr. Plunkett and their teams for several years to study sapacitabine’s effects on the DNA repair pathway. We thus welcome the opportunity to explore the hypothesis that the presence of 11q22-23 deletion may translate into clinical benefit for patients treated with the sapacitabine-based SCR regimen, while doing so in a fiscally responsible and collaborative manner. We look forward to the eventual outcome of this unique study and building our value proposition on data from Cyclacel’s ongoing studies in both hematological malignancies and solid tumors, with emphasis on our SEAMLESS Phase 3 pivotal trial in patients with front-line acute myeloid leukemia (AML).”