Category Archives: Cell Therapy

(SACRAMENTO, Calif.) - The state stem cell agency, California Institute for Regenerative Medicine (CIRM),awarded a pair of grants totaling more than $7 million to UC Davis School of Medicine researchers who are working to develop stem cell therapies for spina bifida and chronic diabetic wounds. The funding is part of what the agency considers "the most promising" research leading up to human clinical trials using stem cells to treat disease and injury. Diana Farmer, professor and chair of surgery at UC Davis Medical Center, is developing a placental stem cell therapy for spina bifida, the common and devastating birth defect that causes lifelong paralysis as well as bladder and bowel incontinence. She and her team are working on a unique treatment that can be applied in utero - before a baby is born -- in order to reverse spinal cord damage. Roslyn Rivkah Isseroff, a UC Davis professor of dermatology, and Jan Nolta, professor of internal medicine and director of the university's Stem Cell Program, are developing a wound dressing containing stem cells that could be applied to chronic wounds and be a catalyst for rapid healing. This is Isseroff's second CIRM grant, and it will help move her research closer to having a product approved by the U.S. Food and Drug Administration that specifically targets diabetic foot ulcers, a condition affecting more than 6 million people in the country. The CIRM board, which met in Berkeley today, has high hopes for these types of research that the agency funded in this latest round of stem cell grants. "This investment will let us further test the early promise shown by these projects," said Jonathan Thomas, chair of CIRM's governing board. "Preclinical work is vital in examining the feasibility, potential effectiveness and safety of a therapy before we try it on people. These projects all showed compelling evidence that they could be tremendously beneficial to patients. We want to help them build on that earlier research and move the projects to the next level." The CIRM grants are designed to enable the UC Davis research teams to transition from preclinical research to preclinical development over the next 30 months to be able to meet the FDA's rigorous safety and efficacy standards for Investigative New Drugs. As the former surgeon-in-chief at UCSF Benioff Children's Hospital, Farmer helped pioneer fetal surgery techniques for treating spina bifida before birth. The condition, also known as myelomeningocele, is one of the most common and devastating birth defects worldwide, causing lifelong paralysis as well as bowel and bladder incontinence in newborns. Farmer has been investigating different stem cell types and the best way to deliver stem cell-based treatments in the womb for the past six years. She and her research colleagues recently discovered a placental therapy using stem cells that cures spina bifida in animal models. That discovery requires additional testing and FDA approval before the therapy can be used in humans. With the CIRM funding, Farmer and her team plan to optimize their stem cell product, validate its effectiveness, determine the optimal dose and confirm its preliminary safety in preparation for human clinical trials. Isseroff, who also serves as chief of dermatology and director of wound healing services for the VA Northern California Health Care System, has long been frustrated by the challenges of treating the chronic, non-healing wounds of diabetics. In 2010, she and Nolta received a CIRM grant to begin developing a bioengineered product for treating chronic diabetic wounds. Foot ulcers, in particular, affect about 25 percent of all diabetic patients and are responsible for most lower-limb amputations. Isseroff and her research team created a treatment using stem cells derived from bone marrow (mesenchymal stem cells) along with a FDA-approved scaffold to help regenerate dermal tissue and restart the healing process. Their studies found the technique to be highly effective for healing wounds in animal models. With this latest CIRM grant, Isseroff's team will refine their therapeutic technique by determining the safest dosage for regenerating tissue and testing their product in skin-wound models that closely resemble those in diabetic humans. Nolta also plans to create a Master Cell Bank of pure and effective human mesenchymal stem cells, and establish standard operating procedures for use in diabetic wound repair. The results of their efforts will enable UC Davis to move closer to FDA approval for human clinical trials in the next two and a half years. "These amazing research efforts are giant steps forward in turning stem cells into cures," said Nolta, who also directs the UC Davis Institute for Regenerative Cures in Sacramento. "This preclinical research is the most crucial, and often the toughest, stage before we move scientific discoveries from the laboratory bench to the patient's bedside. We are now poised as never before to make a big difference in the lives of people with spina bifida and non-healing diabetic wounds." For more information, visit UC Davis School of Medicine at http://medschool.ucdavis.edu.

Originally posted here:
Stem Cell Grants for Spina Bifida and Diabetic Wound Treatments

VANCOUVER -- University of B.C. scientists appear to be one step closer to reversing diabetes using stem cell therapy.

The latest study, published last week in the journal Stem Cell Reports, found that Type 2 diabetes can be eliminated in mice using a combination of conventional diabetes drugs and specially cultured stem cells. Similar methods have already been used to reverse Type 1 diabetes, which usually begins in childhood.

The team simulated Type 2 diabetes in mice by feeding them a high-fat, high-calorie diet for several weeks. In humans, Type 2 usually begins in adulthood and can be a result of obesity, poor diet and lack of exercise.

Like diabetic humans, the diabetic mice treated only with drugs experienced spikes in their blood sugar levels after eating sugary meals.

But the mice that were surgically implanted with pancreatic-like cells grown from human stem cells didnt have those drastic swings and were able to regulate their blood sugar like healthy animals.

Being able to reduce spikes in blood sugar levels is important because evidence suggests its those spikes that do a lot of the damage increasing risks for blindness, heart attack, and kidney failure, said Timothy Kieffer, a professor in UBCs department of cellular and physiological sciences.

So far, the researchers have followed the mice for up to seven months, and theyve remained healthy.

When we removed the transplanted devices and analyzed the cells within, they still appear very healthy so we believe they will function much longer. Ultimately the duration of cell function will need to be assessed in humans, Kieffer said in an email.

Human trials are already underway for stem cell therapy on Type 1 diabetes; the first patient was implanted with cells in October.

The treatment also had a surprising side-effect: weight loss. The mice all returned to the same, healthy weight as the animals in the control group.

Continued here:
Stem cell therapy could reverse Type 2 diabetes, UBC study finds

Those hospitals and medical institutions advertising treatment of incurable diseases with stems cells are now under scanner of the Union Ministry of Health and Family Welfare.

The ministry has already processed complaints against at least 23 website advertisements.

The National Apex Committee for Stem Cell Research and Therapy (NACSCRT), under the Indian Council of Medical Research, has looped in Advertising Standards Council of India (ASCI) to monitor advertisements that claim to fully cure patients with stem cell based therapies.

Several clinics and organisations advertise stem cell therapies whose safety and efficacy are not proven, to attract vulnerable patients. As per the National Guidelines for Stem Cell Research 2013, stem cell therapy has not been proven effective other than in Hematopoietic Stem Cell Transplantation (HSCT) for haematological disorders (disorders which primarily affect the blood).

NAC-SCRT has observed that several clinicians, companies, hospitals advertise stem cell based therapies other than haematopoietic stem cell transplantation for haematological disorders on their websites. Officials clearly say that these therapies are currently investigational and must be conducted only within the scope of clinical trials.

Dr. Alok Srivastava, Chairman, NAC-SCRT said, "Advertisements claiming to offer stem cell-based therapies other than Haematopoietic Stem Cell Transplantations for blood diseases are in violation of the clause 10.3.1 of the National Guidelines for Stem Cell Research-2013."

"Use of stem cells for any other purpose outside the ambit of clinical trials will be against these guidelines and is hence not permissible. We have asked ASCI to review such advertisements and are happy that action has been initiated against 23 such websites. It is necessary that such misleading advertisements be removed and action be taken against the defaulters unless they are suitably modified to clarify the unproven nature of these therapies and are only offered within approved clinical trials. The NAC-SCRT will be reviewing the developments in the field and modifying its position with regard to proven therapies from time to time," he added.

As stem cell-based therapies are currently experimental, advertising these for results not approved by regulatory authorities is in violation of Chapter III of the ASCI code for Self-Regulation of Advertisements. "The code requires that advertisements should not propagate products or services, the use of which is banned under the law," said Narendra Ambwani, Chairman, ASCI.

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Stem cell clinics under govt scanner