December 8, 2011 by

Adult Stem Cell Clinical Trials Showing Success

A Number of Clinical Trials Using Adult Stem Cells Are Showing Early Success

Dozens of adult stem cell treatments are moving through clinical trials and showing early success, raising hopes that some could reach the market within five years. ‘It will only take a few successes to really change the field,’ said Gil Van Bokkelen, chief executive of Athersys and chairman of the Alliance for Regenerative Medicine. ‘As you see things getting closer and closer to that tipping point, you’re going to see a frenzy of activity take place.’ Many of the trials focus on heart disease and inflammatory conditions, some of the biggest markets in medicine. The cells used are derived from adult tissue such as fat, or bone marrow, thereby circumventing the ethical concerns raised by the use of cells derived from embryos.

Data for the most part remains early, but as more results emerge, pharmaceutical companies are beginning to take note. ‘A lot of big companies are looking to place bets on some Phase II products once that data has been confirmed,’ said Paul Schmitt, managing partner at Novitas Capital. ‘Even now they’re attending all the medical meetings and talking to all the stem cell companies.’ Steven Martin, from Aspire Capital Partners LLC said they were willing to be patients as the benefits from treatment could be enormous. ‘My philosophy in the stem cell space is that it’s very difficult at this point to pick the winners and losers,’ he said. ‘We believe that over time there will be some very significant clinical progress, and valuations will improve, but we’re still a long way from an approved therapy.’

Aastrom Biosciences recently presented promising results from a mid-stage trial of its treatment for patients with critical limb ischemia, a disease in which blood flow to the extremities is restricted, at the American Heart Association’s annual meeting. A mid-stage trial from Australia’s Mesoblast Ltd showed its stem cell product reduced the rate of heart attacks and the need for artery clearing procedures by 78 per cent. ‘We’re actually developing products now,’ said Timothy Mayleben, chief executive of Aastrom, which is using cells derived from a patient’s own bone marrow to develop treatments for cardiovascular disease. ‘For the first time you are starting to see data being presented at major medical meetings.’ Pfizer Inc, Johnson & Johnson and Roche Holding AG are members of the Alliance for Regenerative Medicine, a nonprofit group that promotes awareness of the field. Pfizer has a regenerative medicine unit and a partnership with Athersys. But their projects are small as they want to wait to see data in hundreds of patients. The promise of stem cells, which have been used for 40 years in bone marrow transplants, lies in their ability to repair tissue, reduce inflammation, regulate the immune system, and respond to calls for help from multiple places inside the body. Stem cells are the body’s master cells – blank slates that renew themselves and mature into specific cell types in the heart, muscle and other organs.

Embryonic stem cells are uniquely capable of differentiating into every type of mature cell in the body, and were long viewed as the most promising for regenerating tissue. But harvesting stem cells from embryos requires the destruction of the embryo itself, a process opposed by conservative Christian groups. Moreover, their endless capacity to divide can lead to the formation of teratomas, or stem cell cancers. Recently, Geron Corp, the world’s leading embryonic stem cell company, said it could no longer fund its stem cell work and would focus on developing cancer drugs. It closed its trial for spinal cord injury. Unlike embryonic stem cells, adult stem cells have a more limited capacity to differentiate, but appear able to reduce inflammation and promote blood vessel formation. Furthermore, they can respond to damage in the body in a flexible and dynamic way, offering advantages over traditional drugs.
‘They seem to be preprogrammed to act some way in tissue repair, not to form an organ or a tissue,’ said Douglas Losordo, head of stem cell research at Baxter International Inc, which is developing cell therapies for heart disease. ‘The cells that we use are very effective at stimulating the formation of new blood vessels, but if I wanted to make a brain cell out of those cells they would not be very good at it.’ These are the type of stem cell treatments, delivered by infusion, injection or catheter, that are being developed today.
‘We wanted to create a product that everyone could receive and not have to match every donor to every recipient,’ said Robert Hariri, chief executive of Celgene’s Cellular Therapeutics unit.

Different types of stem cell are being used for different diseases. Cytori Therapeutics is developing a heart disease product derived from fat cells, for example, while Celgene is using placental cells for Crohn’s disease and rheumatoid arthritis therapies. Fetal cells are also being explored. Neuralstem Inc, for example, is developing treatments for neurological disorders from an aborted fetus. As cell therapies move further through clinical trials, companies will need more money, and funding is scarce.
Yet even if companies remain afloat long enough to bring a product through late-stage clinical trials, it is unclear what regulators like the Food and Drug Administration will require in order to approve them Some believe the regulatory hurdles for treatments derived from a patient’s own cells will be lower than those where the cells come from donors, since there is less risk of cell rejection. However, no clear pathway has yet been established. ‘We need a clear, consistent and rigorous regulatory framework,’ said Athersys’s Van Bokkelen. ‘The FDA is actually willing to provide lots of guidance and assistance to sponsors, if you just ask them.’

Filed Under: Adult Stem Cells, News, Stem Cell Research Tagged With: , , , , , ,
December 6, 2011 by

Healing juices’ of stem cells could help treat asthma

Research suggests future use of cells in kidney, heart disease
BY BRENT WITTMEIER, EDMONTON JOURNAL DECEMBER 2, 2011

University of Alberta pediatric asthma researcher says that the medical benefits of stem cells may lie in their by-product “healing juices”.

Dr. Bernard Thébaud believes the by-products of mesenchymal stem cells – found in umbilical cord tissue and with known anti-inflammatory characteristics – could possibly heal lungs inflamed by chronic and acute asthma.

The findings, published in the American Journal of Respiratory Cell and Molecular Biology, look at the effects of what Thébaud called “healing juices” on refractory asthma, a form of the disease that is particularly difficult to treat with inhalers.

Thébaud, a neonatal pediatrician and professor of pediatrics at the University of Alberta Faculty of Medicine and Dentistry, said the cells and their juices are easily isolated and cultivated in the lab.

“We cultured the cells in the petri dish, and instead of taking the cells, we just took what the cells produced, the juice they were basically swimming in,” Thébaud said. “We compared that to control cells cultured the same way, but didn’t have that same effect.”

Thébaud’s team created asthma in lab mice, then injected the juices through their noses. The by-products opened airways, restored breathing and reduced inflammation in their lungs.

Thébaud began researching pediatric lung disease in 2002, adding the “exciting” discipline of stem-cell research two years later. The new study builds on some of Thébaud’s previous research into how stem cells work.

“Initially we thought you have to give the cells (to the patient) because they replace dead cells,” he said. “That’s not actually the case.”

Thébaud initially used the mesenchymal stem cells in a study of newborn lung injury, discovering “tremendous benefits” for the health of the lungs. But when his research team tried to see where those stem cells were, they couldn’t find them.

“Maybe they don’t replace dead cells. Maybe they sit there and produce juices, then vanish,” he said.

Although the research is still at an early stage, Thébaud said his hope is for a “super-inhaler” five to 10 years from now that would heal inflammation, boost healthy cells and aid in breathing. He hopes to live the researcher’s dream and drive the discovery from his lab into the clinic.

His goal “would be to have a puffer with stem cell by-products that would prevent those symptoms of asthma,” he said.

Thébaud is convinced it could work. But exactly which compounds or factors are doing the “healing” is hardly academic, and will likely form the next stage in the research.

“It is the question,” said Thébaud. “First, we have to know should we not give the cells, or can we just deliver the juices. Do we have to know what’s in there?”

That question could also delay clinical research by an additional five years, the time he estimates it would take to synthesize the factor pharmaceutically. He will be discussing the study with Health Canada to determine barriers to clinical research using just undifferentiated by-products.

Thébaud also believes the approach demonstrates “many therapeutic avenues” beyond asthma, which affects an estimated 300 million people worldwide. The potential of stem-cell research isn’t yet known.

“It’s up to us now to harness the healing powers of these cells,” he said.

“We know it works in a variety of lung diseases. By extension, we know it will work in kidney, or heart or brain disease as well.”

Filed Under: Adult Stem Cells, Asthma, News, Stem Cell Research Tagged With: , , , , ,
May 27, 2011 by

Stem cell therapy gives dogs new pep in their step

Linda Goldston, lgoldston@mercurynews.com Mercury News
Cookie is a thirteen year-old Australian shepherd mix that has been having increasing trouble lying down and getting up. She could not walk down stairs and even during normal walks around the park her legs would give out. Cookie’s master, Ed Tani of Hayward was terrified that Cookie’s days were numbered. Ed then came across a revolutionary procedure for treating arthritic dogs called stem cell therapy. The treatment had been used with great success in horses for years, but more and more veterinarians are implementing the patented Vet-Stem Regenerative Cell therapy to their medical bag of tricks.
“This is an attempt to turn back time but without drugs,” said Brian Maxwell, a veterinarian whose specialty is orthopedic surgery at Adobe Animal Hospital in Los Altos, where Cookie’s joints were injected with her own stem cells this week.
The procedure of using stem cells to treat arthritis is based on the fact that stem cells have the ability to inhibit inflammation associated with arthritis, as well as to regenerate the injured cartilage. Vet-Stem uses stem cells derived from the fat tissue. Fat tissue contains stem cells that are called “mesenchymal” which are known to produce bone, cartilage, and other types of tissues. Additionally, mesenchymal stem cells also produce anti-inflammatory compounds such as interleukin-10.
Maxwell stated that “about 70 percent of the dogs treated show dramatic improvement; another 20 percent show moderate improvement”. Maxwell stated that of the 10 dogs that were treated so far, all but one of them improved. The dogs’ mobility was better and most of them were able to go off pain pills and anti-inflammatory medication, which can cause kidney and liver problems in many dogs.
“When she was 4 years old, she tore her ACL and had to have surgery,” said Wyle, a lecturer in Stanford University’s program in writing and rhetoric. “I thought, at that point, it was time to do it.”
The treatment of autologous fat stem cells have been performed by Vet-Stem since 2003. There have been numerous studies published by Vet-Stem regarding the treatment of dogs and horses using fat stem cells. For example in Black et al. Vet Ther. 2008 Fall;9(3):192-200, Dr. Harman’s group reported that “effectiveness of this therapy in dogs with chronic osteoarthritis of the humeroradial (elbow) joints and to determine the duration of effect. Fourteen dogs were recruited. Veterinarians assessed each dog for lameness, pain on manipulation, range of motion, and functional disability using a numeric rating scale at baseline and specified intervals up to 180 days after treatment. Statistically significant improvement in outcome measures was demonstrated.”

Filed Under: Adult Stem Cells, Arthritis, News, Stem Cell Research Tagged With: , , , ,
April 27, 2011 by

Forcing Stem Cells into Circulation Results in Protection from Liver Failure in Animals

Zhang et al. Toxicol Lett.
While previous studies showed that administration of bone marrow cells are capable of repairing livers in animal and human studies, relatively little work has been performed to augment existing means by which the body uses its own stem cells to heal the liver. Specifically, it has been demonstrated that in liver failure bone marrow stem cells exit the bone marrow and home to the damaged liver. While conventional approaches include performing a bone marrow aspiration and mechanically placing the bone marrow into the liver, usually vial the hepatic artery, an alternative would be administration of a chemical that “instructs” the bone marrow stem cells to exit the bone marrow and go into systemic circulation. The other approach would be to augment the chemical signals that the injured liver produces to attract stem cells. This approach is currently pursued in other indications by the company Juventas. Stromal Derived Factor (SDF)-1 is produced by injured tissues and induces migration of bone marrow stem cells. The genetic administration of SDF-1 into already injured tissues causes an increase in stem cell trafficking and has been demonstrated to augment existing regenerative mechanisms.
A recent study (Zhang et al. Granulocyte colony-stimulating factor treatment ameliorates liver injury and improves survival in rats with d-galactosamine-induced acute liver failure. Toxicol Lett. 2011 Apr 27) from the First Affiliated Hospital, School of Medicine, of the Xi’an Jiaotong University demonstrated that administration of the stem cell mobilizer G-CSF into rats with chemically induced liver failure results in prolonged survival and the appearance of liver regeneration.
The investigators administered a single dose of d-galactosamine (d-GalN, 1.4g/kg) to induce ALF. After 2h, the rats were randomized to receive G-CSF (50μg/kg/day), or saline vehicle injection for 5 days. In the liver failure model, 5-day survival after d-GalN injection was 33.3% (10/30), while G-CSF administration following d-GalN resulted in 53.3% (16/30) survival (p=0.027). G-CSF treated rats had lower ALT level and less hepatic injury compared with saline vehicle rats. The increases of CD34+ cells in bone marrow and liver tissue and Ki-67+ cells in liver tissue in G-CSF treated rats were higher than those in saline rats.
These data suggest the possibility that stem cell therapy using chemicals that mobilize endogenous stem cells may be useful in the treatment of liver failure. It remains to be seen whether other chemicals associated with mobilization may cause improved outcome. For example, in addition to G-CSF, agents such as M-CSF, GM-CSF, parathyroid hormone, and the CXCR4 antagonist Mozibile are all capable of inducing mobilization of different types of stem cells.

Filed Under: Adult Stem Cells, Liver, News, Stem Cell Research Tagged With: , , , ,
April 12, 2011 by

Immune Cells Killing Stem Cells and Stem Cells Killing Immune Cells

Knight et al. J Neurol Sci.
Several studies have demonstrated that stem cells are useful in the treatment of multiple sclerosis. The Cellmedicine clinic published previously in collaboration with the University of California San Diego that 3 patients treated with their own fat derived stem cells entered remission. Other studies are ongoing, including a study at the Cleveland Clinic in which bone marrow stem cells differentiated into mesenchymal stem cells are being administered into patients with multiple sclerosis. Unfortunately the mechanisms by which therapeutic effects occur are still largely unknown. One general school of thought believes that stem cells are capable of differentiating into damaged brain cells. The other school of thought believes that stem cells are capable of producing numerous growth factors, called trophic factors, that mediate therapeutic activity of the stem cells. Yet another school of thought propagates the notion that stem cells are merely immune modulatory cells. Before continuing, it is important to point out that stem cell therapy for multiple sclerosis involving autologous hematopoietic transplants is different than what we are discussing here. Autologous (your own) hematopoietic stem cell therapy is not based on regenerating new tissues, but to achieve the objective of extracting cells from a patients, purifying blood making (hematopoietic) stem cells, destroying the immune system of the recipient so as to wipe out the multiple sclerosis causing T cells, and subsequently readministering the patient’s own cells in order to regenerate the immune system. This approach, which was made popular by Dr. Richard Burt from Northwestern University.
In order to assess mechanisms of how stem cells work in multiple sclerosis it is necessary to induce the disease in animals. The most widely used animal model of multiple sclerosis is the experimental allergic encephalomyelitis model. This disease is induced in female mice that are genetically bred to have a predisposition to autoimmunity. These animals are immunized with myelin basic protein or myelin oligodendrocyte protein. Both of these proteins are components of the myelin sheath that protects the axons. In multiple sclerosis immune attack occurs against components of the myelin sheath. Therefore immunizing predisposed animals to components of the myelin sheath induces a disease similar to multiple sclerosis. The EAE model has been critical in development of some of the currently used treatments for multiple sclerosis such as copaxone and interferon.
Original studies have demonstrated that administration of bone marrow derived mesenchymal stem cells protects mice from development of EAE. This protection was associated with regeneration on oligodendrocytes as well as shifts in immune response. Unfortunately these studies did not decipher whether the protective effects of the stem cells were mediated by immune modulation, regeneration, or a combination of both. Other studies have shown that MSC derived from adipose tissue had a similar effect. One interesting point of these studies was that the stem cell source used was of human origin and the recipient mice were immune competent. One would imagine that administration of human cells into a mouse would result in rapid rejection. This did not appear to be the case since the human cells were found to persist and also to differentiated into human neural tissues in the mouse. One mechanism for this “immune privilege” of MSC is believed to be their low expression of immune stimulatory molecules such as HLA antigens, costimulatory molecules (CD80/86) and cytokines capable of stimulating inflammatory responses such as IL-12. Besides not being seen by the immune system, it appears that MSC are involved in actively suppressing the immune system. In one study MSC were demonstrated to naturally home into lymph nodes subsequent to intravenous administration and “reprogram” T cells so as to suppress delayed type hypersensitive reactions. In those experiments scientists found that the mechanism of MSC-mediated immune inhibition was via secretion of nitric oxide. Other molecules that MSC use to suppress the immune system include soluble HLA-G, Leukemia Inhibitor Factor (LIF), IL-10, interleukin-1 receptor antagonist, and TGF-beta. MSC also indirectly suppress the immune system by secreting VEGF which blocks dendritic cell maturation and thus prevents activation of mature T cells.
While a lot of work has been performed investigating how MSC suppress the immune system, relatively little is known regarding if other types of stem cells, or immature cells, inhibit the immune system. This is very relevant because there are companies such as Stem Cells Inc that are using fetally-derived progenitor cells therapeutically in a universal donor fashion. There was a paper from an Israeli group demonstrating that neural progenitors administered into the EAE model have a therapeutic effect that is mediated through immune modulation, however, relatively little work has been performed identifying the cell-to-cell interactions that are associated with such immune modulation.
Recently a paper by Knight et al. Cross-talk between CD4(+) T-cells and neural stem/progenitor cells. Knight et al. J Neurol Sci. 2011 Apr 12 attempted to investigate the interaction between immune cells and neural stem cells and vice versa. The investigators developed an in vitro system in which neural stem cells were incubated with CD 4 cells of the Th1 (stimulators of cell mediated immunity), Th2 (stimulators of antibody mediated immunity) and Th17 (stimulators of inflammatory responses) subsets. In order to elucidate the impact of the death receptor (Fas) and its ligand (FasL), the mouse strains lpr and gld, respectively, were used.
The investigators showed that Th1 type CD4 cells were capable of directly killing neural stem cells in vitro. Killing appeared to be independent of Fas activation on the stem cells since gld derived T cells or lpr derived neural stem cells still participated in killing. Interestingly, neural stem cells were capable of stimulating cell death in Th1 and Th17 cells but not in the Th2 cells. Killing was contact dependent and appeared to be mediated by FasL expressed on the neural stem cells. This is interesting because some other studies have demonstrated that FasL found on hematopoietic stem cells appears to kill activated T cells. In the context of hematopoietic stem cells this phenomena may be used to explain clinical findings that transplanting high numbers of CD34 cells results in a higher engraftment, mediated in part by killing of recipient origin T cells.
The finding that neural stem cells express FasL and selectively kill inflammatory cells (Th1 and Th17) while sparing anti-inflammatory cells (Th2) indicates that the stem cells themselves may be therapeutic by exerting an immune modulatory effect. One thing that the study did not do is to see if differentiated neural stem cells would mediate the same effect. In other words, it is essentially to know if the general state of cell immaturity is associated with inhibition of inflammatory responses, or whether this is an activity specific to neurons. As mentioned above, previous studies have demonstrated that mesenchymal stem cells (MSC) are capable of eliciting immune modulation through a similar means. Specifically, MSC have been demonstrated to stimulate selective generation of T regulatory cells. This cell type was not evaluated in the current study, however some activities of Th2 cells are shared with Treg cells in that both are capable of suppressing T cytotoxic cell activation. In the context of explaining biological activities of stem cell therapy studies such as this one stimulate the believe that stem cells do not necessarily mediate their effects by replacing damaged cells, but by acting on the immune system. Theoretically, one of the reasons why immature cells are immune modulatory in the anti-inflammatory sense may be because inflammation is associated with oxidative stress. Oxidative stress is associated with mutations. Conceptually, the body would want to preferentially protect the genome of immature cells given that the more immature the cells are, the more potential they have for stimulation of cancer. Mature cells have a limited self renewal ability, whereas immature cells, given they have a higher potential for replication are more likely to accumulate genomic damage and neoplastically transform.

Filed Under: Adult Stem Cells, Multiple Sclerosis, Multiple Sclerosis, News, Stem Cell Research, Stem Cell Therapy Tagged With: , , , , , , , , , , , ,
March 14, 2011 by

StemCells, Inc. Initiates World’s First Neural Stem Cell Trial In Spinal Cord Injury

StemCells Inc Press Release
StemCells Inc announced today they are initiating a clinical trial using their fetal derived neural progenitor cells for the treatment of spinal cord injuries. Previously the company had reported that their stem cells, called HuCNS-SC, are capable of differentiating into various neural lineage cells including neurons, oligodendrocytes, and astrocytes. The fact that HuCNS-SC are derived from fetal sources allows them to possess a lower ability to stimulate immune responses, therefore, the cells can be used as an “off the shelf” product.
According to the company “The Company’s preclinical research has shown that HuCNS-SC cells can be directly transplanted in the central nervous system (CNS) with no sign of tumor formation or adverse effects. Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, this suggests the possibility of a durable clinical effect following a single transplantation. StemCells believes that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the CNS, and to date has demonstrated human safety data from completed and ongoing studies of these cells in two fatal brain disorders in children.”
The proposed study will be conducted at the Balgrist University Hospital, in Zurich, which is a private, non-profit institution managed in accordance with economic principles. The clinic has three key areas of expertise: it is a highly specialised centre providing examination, treatment and rehabilitation opportunities to patients with serious musculoskeletal conditions; it is responsible for training future doctors studying at the University of Zurich in orthopaedics and paraplegiology and providing professional training for doctors and medical staff in the domains of orthopaedics, paraplegiology, rheumatology, anaesthesiology and radiology; it is a research centre dedicated to improving quality for healthcare in the future. The number of patients or inclusion/exclusion criteria for the trial was not mentioned in the press release. However a look at clinicaltrials.gov reveals the following:
The study is a 12 patient Phase I/II trial in which treated patients will also receive immune suppression so that the transplanted cells will not be rejected. The trial has the following inclusion/exclusion criteria:
Inclusion Criteria:
• T2-T11 thoracic spinal cord injury based on American Spinal Injury Association (ASIA) level determination by the principal investigator (PI)
• T2-T11 thoracic spinal cord injury as assessed by magnetic resonance imaging (MRI) and/or computerized tomography (CT)
• ASIA Impairment Scale (AIS) Grade A, B, or C
• Minimum of six weeks post injury for the initiation of screening
• Must have evidence of preserved conus function
• Must be at stable stage of medical recovery after injury
Exclusion Criteria:
• History of traumatic brain injury without recovery
• Penetrating spinal cord injury
• Evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma
• Previous organ, tissue or bone marrow transplantation
• Previous participation in any gene transfer or cell transplant trial
• Current or prior malignancy
Success in treatment of spinal cord injury has been reported in the peer reviewed literature by Cellmedicine in which a patient was treated with a combination of cord blood hematopoietic and placental matrix mesenchymal stem cells http://www.intarchmed.com/content/pdf/1755-7682-3-30.pdf.
The advantage of the approach proposed by StemCells Inc is that only one injection of stem cells may be necessary . The disadvantage is that while the stem cells may generate neurons, it is difficult to imagine how one source of stem cells alone can recapitulate and accelerate the multicellular process involved in healing of the spinal cord.
Treatment of spinal cord injuries using stem cells is also underway by the company Geron who uses embryonic stem cell derived oligodendrocytes in patients with spinal cord injury.
Two previous trials have been reported in the area of spinal cord injury that used mesenchymal stem cells exclusively. In 2006 the group of Movilgia et al from Argentina treated two patients with spinal cord injury using an interesting protocol of T cell plus MSC. Forty-eight hours prior to NSC implant, patients received an i.v. infusion of 5 x 10(8) to 1 x 10(9) AT cells. NSC were infused via a feeding artery of the lesion site. Safety evaluations were performed everyday, from the day of the first infusion until 96 h after the second infusion. Patient 1 was a 19-year-old man who presented paraplegia at the eight thoracic vertebra (T8) with his sensitive level corresponding to his sixth thoracic metamere (T6). He received two AT-NSC treatments and neurorehabilitation for 6 months. At present his motor level corresponds to his first sacral metamere (S1) and his sensitive level to the fourth sacral metamere (S4). Patient 2 was a 21-year-old woman who had a lesion that extended from her third to her fifth cervical vertebrae (C3-C5). Prior to her first therapeutic cycle she had severe quadriplegia and her sensitive level corresponded to her second cervical metamere (C2). After 3 months of treatment her motor and sensitive levels reached her first and second thoracic metameres (T1-T2). No adverse events were detected in either patient (Moviglia, G.A., et al., Combined protocol of cell therapy for chronic spinal cord injury. Report on the electrical and functional recovery of two patients. Cytotherapy, 2006. 8(3): p. 202-9).
Pal et al from Stemeutics in India reported 30 patients with clinically complete SCI at cervical or thoracic levels were recruited and divided into two groups based on the duration of injury. Patients with <6 months of post-SCI were recruited into group 1 and patients with >6 months of post-SCI were included into group 2. Autologous BM was harvested from the iliac crest of SCI patients under local anesthesia and BM MSC were isolated and expanded ex vivo. BM MSC were tested for quality control, characterized for cell surface markers and transplanted back to the patient via lumbar puncture at a dose of 1 x 10(6) cells/kg body weight. Three patients had completed 3 years of follow-up post-BM MSC administration, 10 patients 2 years follow-up and 10 patients 1 year follow-up. Five patients have been lost to follow-up. None of the patients have reported any adverse events associated with BM MSC transplantation (Pal, R., et al., Ex vivo-expanded autologous bone marrow-derived mesenchymal stromal cells in human spinal cord injury/paraplegia: a pilot clinical study. Cytotherapy, 2009. 11(7): p. 897-911)
A search of clinicaltrials.gov for ongoing trials using stem cells in patients with spinal cord injury reveals the following:
1. Cairo University is performing a Phase I/II trial in 80 patients with spinal cord injury who are receiving autologous bone marrow derived stem cells. The trial includes patients that are treated with stem cells and receive physical therapy versus patients receiving physical therapy alone. The trial has completed enrollment and recruited patients who had injury 8 months to 3 years before entering the trial.

2. RNL Bio from Korea is performing a Phase I study on 8 spinal cord injury patients who had their injuries more than two months before entering the study. The cells administered are 40 million autologous adipose derived cells, given intravenously. The trial enrollment is completed and the Principle Investigator is Dr. SangHan Kim, MD from the Anyang Sam Hospital.

3. International Stemcell Services Limited from India is doing a 12 patient Phase I/II trial administering autologous bone marrow into patients after spinal cord injury. The trial enrollment is completed and the Principle Investigator is Dr.Arvind Bhateja, from the Sita Bhateja Speciality Hospital.

4. TCA Biosciences from Louisiana is performing a 10 patient Phase I trial using autologous bone marrow mesenchymal stem cells. The trial enrollment is completed.

5. The Memorial Hermann Healthcare System is doing a study using autologous bone marrow cells in children aged 1-15 using autologous bone marrow cells. The study plans to enroll 10 patients.

6. The Hospital Sao Rafael from Brazil is doing a 10 patient study using autologous bone marrow in spinal cord injury patients.
This exploration of clinicaltrials.gov tells us that relatively little is being performed in terms of stem cell therapy for spinal cord injury. Given the success of Cellmedicine at treating this condition, it will be interesting to see the outcomes of the other ongoing trials.

Filed Under: Adult Stem Cells, Clinical Trials, Spinal Cord Injury, Stem Cell Research Tagged With: , , , ,
February 23, 2011 by

Stem Cell Technique Could Help Those With Fast-aging Disease

Washington Examiner

February 23, 2011

Hutchinson-Gilfod progeria syndrome is a fast-aging disease that is rare, has no cure, and is fatal. Children with this disease undergo rapid aging and generally do not live to their teens. It is caused by a single mutation of the LMNA gene, which results in a defect in the production of lamin A, a protein which is required to build the membranous shell around genetic material. The majority of children with Hutchinson-Gilford progeria die from complications pertaining to hardening of their blood vessels. Fortunately, this disease is very rare, as only 64 children in the world are known to have it, however due to the small number of patients suffering from this disease, there are very few opportunities to study it and thus form any type of treatment.

New technology has introduced a new possibility in the treatment of this progeria. In the past five years, scientists have begun using targeted retroviruses that selectively alter DNA in order to cause a regression of cells from the muscle or skin into their stem cell form, pluripotent stem cells. Pluripotent stem cells have the potential to form various different types of cells in the body, depending on where they are transplanted to.

The cells that were taken from the patients were regressed back to their pluripotent stem cell stage by a research team led by Juan Carlos Izpisua Belmonte and Guanghui Liu at the Salk Institute in La Jolla, California. The researchers found that after this regression, the cells from the patients no longer contained the information that corresponded to diseased cells. However, despite the absence of the mutation in the stem cell state, these cells would not necessarily be rid of the defect which sets the fate for the disease. The resetting of the cells does allow for the scientists to study the progression of the disease its beginning.

Liu’s lab is working on a technique that will fix the genetic mutation responsible for the progeria in hopes of developing a treatment or even a cure for the disease. “Hopefully our efforts will be useful to generate … [non-symptomatic] progeria cells and help those progeria patients in the near future,” he said.

Filed Under: Adult Stem Cells, News, Stem Cell Research Tagged With: , , , ,
February 22, 2011 by

PRECISE: Adipose-derived stem cells show utility as therapy

Cardiology Today

PRECISE is The Randomized Clinical Trial of Adipose-Derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium, a double blind, placebo-controlled trial involving 27 patients with chronic ischemic heart disease with HF, angina or both, who were not eligible for percutaneous or surgical revascularization. The patients in the study underwent a liposuction to remove adipose tissue from their abdomen, the stem cells were separated and then reinjected directly into the heart. Placebo patients received the same treatment however were injected with placebo in place of stem cells. “These patients were not even able to be transplanted. So these were very high-risk, no-option patients,” said Francisco Fernández-Avilés, MD, with the department of cardiology, Hospital General Universitario Gregorio Marañón, Madrid, and PRECISE investigator.

The patients who were treated with stem cells had improved infarct size at 6 months and peak oxygen consumption compared to the placebo patients. “In my opinion, the results of the PRECISE trial are good enough to reconsider the possibility to start a larger scale randomized trial comparing cells to placebo in terms of left ventricular function, mainly clinical outcomes [like] mortality, HF and ischemia,” Fernández-Avilés said. For the years ahead, Fernández-Avilés said in patients with chronic HF and viability, the answer for stem cell therapy is adipose tissue, “and for patients with no viability, in my opinion, we need more basic investigation to find more effective cells.”

Filed Under: Adult Stem Cells, Heart Disease, News, Stem Cell Research, Stem Cell Therapy Tagged With: , , , , , ,
February 20, 2011 by

Stem Cells Help Women Regrow Breasts After A Mastectomy

By Lucy Johnston

Express News

Scientists in the UK and Australia have been implementing a new technique to benefit women who have had a mastectomy to remove cancerous cells. The technique involves placing a special plastic mould under the skin and then injecting the area with the patient’s own stem cells. The cells are cultured from adipose tissue that is removed from the patient by liposuction. The stem cells are removed from the fat tissue and grown to a larger number, then recombined with the fat and injected back into the body. Results generally take from six months to a year, over which the fat and stem cells grow slowly until new breast tissue is formed. Since the tissue is grown by the patients’ own body, the breasts look and feel natural and are much more comfortable than silicone implants.

The treatment was discovered by observing the way the body reacts to wounds. “Nature doesn’t like a vacuum,” said Professor Wayne Morrison of Melbourne University, who has performed the procedure himself, “so the chamber itself, because it is empty, tends to be filled in by the fat. We observed this and decided it could be used to help treat women who’d lost their breasts to ­cancer. Fat cells can grow to fill a void in the same way that the body repairs tissue damage. Our research shows fat ­continued to grow until it had filled the area where there had once been a ­natural breast. We attach the area to a blood supply from the chest or under the arm which helps the fat grow. The mould used by surgeons helps create a breast shape in which the fat forms.”

The current treatment for mastectomy patients involves taking tissue from the buttock to form a new breast. The results of this treatment are variable, however, and the implementation of the use of stem cells will hopefully improve the outlooks for women. The treatment could also have potential for cosmetic surgeries as well, possibly replacing saline or silicone implants, which have been associated with various side effects.
Professor Morrison said: “We hope the technology will have a significant impact around the world. There are a lot of women who don’t have ­reconstructive surgery for whatever reason or have silicone breast implants but this will give them their own tissue back.”

The patients that have been treated so far have had very impressive results, according to Professor Kefah Mokbel, consultant breast surgeon at St. George’s Hospital, London. The plastic scaffolding used as a mould must be removed surgically, however the procedure is minimally invasive. Researchers hope to develop a biodegradable scaffold which will dissolve once the implant has grown. The treatment is also not used on women who have been cancer free for less than a year, in order to prevent the stem cells from causing further tumor growth.

Filed Under: Adult Stem Cells, News, Stem Cell Research Tagged With: , , , , , ,
February 8, 2011 by

Skin-cell spray gun drastically cuts healing time for burns

In the past, the most common way to treat first to second degree burns is with skin grafts, a process that includes taking pieces of skin from uninjured parts of the patient’s body or grafting artificial skin and grafting them over the burned area. This treatment was somewhat effective, however resulted in a recovery period of several weeks to several months. A new treatment has been developed that drastically decreases the amount of time required for a burn to heal.

A “gun” that has been developed to spray a layer of the patient’s own skin stem cells onto the wounded area has proved to be very successful. This type of treatment has been used since 2002 in Australia, Dr. Fiona Wood uses an aerosol system to spray on cultured skin cells.

The process necessary to initiate this treatment is very minimal, a biopsy is taken from the patient’s undamaged skin, healthy stem cells are isolated and an aqueous solution containing the cells is inserted into the gun and then sprayed on. The “gun” uses an electronically controlled pneumatic device that functions similar to a paint ball gun. After the cells are applied, a specially developed dressing is applied along with two sets of tubes, one functioning as an artery, supplying electrolytes, antibiotics, amino acids and glucose to the wounded area, and one set acting as a vein.

Currently, the treatment is only effective on second-degree burns, healing these within days rather than weeks or months required with previous treatments.

Filed Under: Adult Stem Cells, News, Stem Cell Research Tagged With: , , , , ,
« Previous Page
Next Page »