Stem Cell Clinic

Stem Cell Research and Your Dog

By Kim Ribbink, Studio One Networks

Stem cell research often conjures images of political firestorms and futuristic science, yet it's a field that's already offering hope for humans and dogs alike. While the ideal of fixing spinal injuries and curing disease may be a long way off, dogs treated with stem cells are enjoying a new lease on life.

Pepper, a 10-year-old standard poodle, is a case in point. Crippled with arthritis in both his hips, Pepper came to James Gaynor, DVM, M.S., medical director of Animal Anesthesia & Pain Management Center in Colorado Springs, Colo., with his owners, who fully expected to have to put their pet to sleep. Conventional treatments hadn't worked, or had made their dog even sicker. In fact, Pepper's owners were so certain nothing could be done that they bought another puppy. "At our 60 day recheck, the owner was hugging me and crying out of happiness because, in her words, we gave her back her dog," Dr. Gaynor says. "The only problem was she now had Pepper and a puppy."

Healthy Bones It wasn't long ago that dogs like Pepper with arthritis had few options beyond conventional anti-inflammatory treatments -- including a variety of non-steroid anti-inflammatory drugs (NSAIDs) such as Metacam, Previcox, Rimadyl and phenylbutazone; steroid medications such as Prednisone; and disease-modifying osteoarthritis drugs (DMOADs) such as Adequan Canine -- that sometimes don't work. Now stem cells are providing an alternative. One California-based company, Vet-Stem, uses stem cells from dogs' own fat to treat animals in pain.

According to Julie Ryan Johnson, DVM, vice president of sales and marketing, studies have shown that fat is very rich with stem cells, making it an ideal source, and one that is nearly free from controversy, given that most of us don't mind having a bit of fat removed. "The way we do this is a veterinarian will send us a sample of the dog's fat," Dr. Ryan Johnson says. "We isolate the stem cells from that and then send the stem cells back to the veterinarian who injects them back into the dog -- for example, into an arthritic hip or elbow."

Once in the dog, the stem cells communicate with other cells in their environment. While it's not known exactly how they work, they do decrease the dog's pain level. "It's provided the veterinarian with another solution for helping these animals that have pain or difficulty moving," Dr. Ryan Johnson says. "Most importantly, for the dog and the dog owner, it offers quality of life."

The Possibilities Richard Vulliet, Ph.D., DVM, professor and director of the Laboratory of Veterinary Cytotherapeutics at UC Davis, says stem cells haven't cured any diseases yet, but researchers are working hard to change that. "I think that stem cells in general will rewrite the medical textbooks in the next 10 to 20 years," Dr. Vulliet says. "They will have an impact on human, canine, feline and equine health and will allow us to treat diseases that we can only dream about at this time."

Tony Kremer, DVM, an Illinois-based veterinary surgeon, says that as research progresses into the origin of diseases, there is hope that stem cell therapy might one day be used to treat diabetes and muscular dystrophy in dogs. "It is hoped that this research can repair or replace diseased organs, severed spinal cords, or brain cells destroyed by Alzheimer's disease in humans and dogs," he says.

Dr. Vulliet works with adult bone marrow stem cells to investigate potential cures for diseases that cause misery for many dogs. Your dog may soon be able to get breakthrough treatment in the following areas:

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Stem Cell Research and Your Dog

UCI researchers' work could help paralyzed patients

Two UC Irvine associate professors have laid the foundation for a treatment that could help people who are paralyzed by spinal cord injuries.

Aileen Anderson and Brian Cummings developed a stem cell treatment in collaboration with Northern California-based StemCells Inc. that is being used in clinical trials in Switzerland.

The treatment has resulted in the world's first case of patients regaining some feeling, according to UCI.

"We think this really bodes well for the next stage of the trial," Anderson said.

The initial clinical trial at the Balgrist University Hospital in Zurich injected adult human neural stem cells into the spinal cords of three paralyzed patients.

Two have regained some feeling of touch and heat, according to StemCells Inc., which developed the cell.

The treatment has the potential to not only restore feeling, but also help restore control over bowel movements, said UCI spokesman Tom Vasich.

The trial shows strong evidence that the cell is doing what it was created to do, but the results are not yet concrete, Anderson said. The trial only used three patients, an initial group to determine if the approach is safe, and it didn't have a control group.

"Despite all of these caveats, it's much more than we hoped for," she said. "We're all ecstatic."

The clinical trials are the newest phase of a nearly 10-year research project.

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UCI researchers' work could help paralyzed patients

Stem-cell-protecting drug could prevent the harmful side effects of radiation therapy

Public release date: 6-Sep-2012 [ | E-mail | Share ]

Contact: Elisabeth Lyons elyons@cell.com 617-386-2121 Cell Press

Radiation therapy is one of the most widely used cancer treatments, but it often damages normal tissue and can lead to debilitating conditions. A class of drugs known as mammalian target of rapamycin (mTOR) inhibitors can prevent radiation-induced tissue damage in mice by protecting normal stem cells that are crucial for tissue repair, according to a preclinical study published by Cell Press in the September issue of the journal Cell Stem Cell.

"We can exploit the emerging findings for the development of new preventive strategies and more effective treatment options for patients suffering this devastating disease," says senior study author J. Silvio Gutkind of the National Institute of Dental and Craniofacial Research.

In response to radiation therapy, cancer patients often develop a painful condition called mucositistissue swelling in the mouth that can leave these patients unable to eat or drink and force them to rely on opioid-strength pain killers. Radiation therapy may cause this debilitating condition by depleting normal stem cells capable of repairing damaged tissue.

In the new study, Gutkind and his team found that the mTOR inhibitor rapamycin protects stem cells taken from the mouths of healthy individuals (but not cancer cells) from radiation-induced death and DNA damage, dramatically extending the lifespan of these normal stem cells and allowing them to grow. Rapamycin exerted these protective effects by preventing the accumulation of harmful molecules called reactive oxygen species. Moreover, mice that received rapamycin during radiation treatment did not develop mucositis.

Because rapamycin is approved by the Food and Drug Administration and is currently being tested in clinical trials for the prevention and treatment of various types of cancer, the new findings could have immediate and important implications for a large proportion of cancer patients. "Mucositis prevention would have a remarkable impact on the quality of life and recovery of cancer patients and at the same time would reduce the cost of treatment," Gutkind says. "Our study provides the basis for further testing in humans, and we hope that these findings can be translated rapidly into the clinic."

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Iglesias-Bartolome et al.: "mTOR inhibition prevents epithelial stem cell senescence and protects from radiation-induced mucositis."

Finkel et al.: "Relief with Rapamycin: mTOR Inhibition Protects against Radiation-Induced Mucositis"(In Translation Article)

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Stem-cell-protecting drug could prevent the harmful side effects of radiation therapy

Spinal Stem Cell Injections Help Reverse Paralysis [Medicine]

A new medical intervention has allowed doctors to inject neural stem cells into the spines of paralyzed patients, successfully helping them recover feeling in previously unresponsive parts of their bodies.

New Scientist reports that a small trial involving three partially paralyzed patients saw injections of 20 million neural stem cells administered directly into their spinal cords. The stem cells were harvested from donated fetal brain tissue, and the patients received immunosuppressive drugs to minimize the risks of rejection.

Before treatment, all of the patients could feel nothing below their nipples. Six months on, two of them can now feel touch and heat as far down as their belly button. While that may not sound impressive, it's a massive leap forward in the treatment of paralysis. Stephen Huhn, one of the researchers, told New Scientist:

"The fact we've seen responses to light touch, heat and electrical impulses so far down in two of the patients is very unexpected. They're really close to normal in those areas now in their sensitivity."

These three patients are the first of 12 to undergo the therapy, and the positive results will see Huhn and his colleagues push on with the tests. The results were presented yesterday in London at the annual meeting of the International Spinal Cord Society.

While it's not clear exactly how the stem cells improve sensitivity, the researchers suggest that they may be helping restore myelin insulation of damaged nerves, or perhaps causing existing nerves to function better.

It's too early to tell for sure whether the treatment could represent a standalone treatment for paralysis. It does, however, offer hope that in the futureperhaps when combined with drugs and physical therapythe treatment could help make paralysis a temporary, rather than permanent, condition. [New Scientist]

Image by Sebastian Kaulitzki/Shutterstock

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Spinal Stem Cell Injections Help Reverse Paralysis [Medicine]

2 of 3 spinal injury patients see gains in stem cell trial

Interim results from three patients in an early-stage trial of StemCells Inc's experimental cell treatment for chronic spinal cord injury show that two of them experienced gains in "sensory function," the company said.

StemCells is using neural stem cells, technically adult stem cells, taken from the partly developed brains of fetuses and tested for qualities showing they are destined to form particular types of nerve cells.

The company said that six months after being infused with the cells all three patients have tolerated the transplantation well and there are no safety concerns.

"We clearly need to collect more data to establish efficacy, but we are encouraged," Stephen Huhn, vice president at StemCells, said in a statement. He also said the company is pushing ahead with plans to dose patients with incomplete spinal cord injuries.

The initial phase of the trial involved patients with complete injuries and no neurological function below the level of the spinal injury.

Changes in sensitivity to touch, heat and electrical stimuli were observed in areas below the level of injury in two of the patients, while no changes were seen in the third patient, the company said.

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2 of 3 spinal injury patients see gains in stem cell trial

PropThink: Interim Data In Spinal Cord Injury Driving STEM Higher; PSTI Reacting in Sympathy

This morning, StemCells, Inc. (STEM) released six-month interim results for the first group of patients in its Phase I/II trial, testing the company`s HuCNS-SC (human neural stem cells) treatment candidate in patients with spinal cord injury - previous coverage available here. Shares are trading up nearly 20% in pre-market, and are likely to maintain momentum on the positive news. The interim data showed that thus far, HuCNS-SC treatment led to considerable gains in sensory function in two of three patients vs. their baseline levels of sensation prior to cell transplantation. The company also noted that the treatment continues to exhibit a favorable safety profile. The trial represents the first time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury, and the sensory gains observed have developed in a progressive pattern below the level of injury. Impressively, gains in sensation are not generally expected in spinal cord injury patients, particularly given the severity of injury seen in patients admitted to the Phase I/II study. According to STEM, sensory function of all patients observed thus far was stable before cell transplantation, therefore, the reappearance of sensation is a very positive sign that the treatment is having a beneficial effect. While the third patient did not experience an increase in sensation, that patient`s level of sensation remains stable. PropThink notes that another small-cap stem cell company, PluriStem Therapeutics (PSTI) is also moving in pre-market trading, likely in sympathy with the STEM news.

To see this article at PropThink.com, click here.

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PropThink: Interim Data In Spinal Cord Injury Driving STEM Higher; PSTI Reacting in Sympathy

AlloCure Begins Phase 2 Clinical Trial in Acute Kidney Injury

BURLINGTON, Mass.--(BUSINESS WIRE)--

AlloCure, Inc. today announced that it has initiated a phase 2 clinical trial of AC607, the companys mesenchymal stem cell therapy, as a potential treatment for acute kidney injury (AKI). The randomized, double-blind, placebo-controlled, multi-center trial, designated ACT-AKI (AC607 Trial in Acute Kidney Injury) (NCT01602328), will enroll 200 cardiac surgery subjects at leading tertiary care centers in the United States.

ACT-AKI follows the positive results from a phase 1 AC607 trial in cardiac surgery subjects, which showed an excellent safety profile and encouraging data on the incidence of AKI and hospital length of stay, said Robert M. Brenner, M.D., AlloCure President and Chief Executive Officer. We have worked closely with leaders in the field on the design of ACT-AKI, and trial initiation represents an important milestone for AlloCure and the patients we collectively serve.

AC607 is a promising therapeutic candidate for AKI, for which effective therapies are greatly needed, said Richard J. Glassock, M.D., Emeritus Professor of Medicine at the Geffen School of Medicine at the University of California, Los Angeles. The initiation of ACT-AKI represents a critical step in the development of an innovative therapy for this all-too-common, serious and costly medical condition, for which no approved treatments currently exist beyond supportive care.

About AC607

AC607 is a novel biologic therapy under development for the treatment of AKI. AC607 also possesses potential applications in other grievous illnesses. AC607 comprises allogeneic bone marrow-derived mesenchymal stem cells that are harvested from healthy adult donors and then expanded via a mature and state-of-the art manufacturing process. AC607 homes to the site of injury where it mediates powerful anti-inflammatory and organ repair processes via the secretion of beneficial paracrine factors, without differentiation and repopulation of the injured kidney. Importantly, AC607 avoids recognition by the hosts immune system, enabling administration in an off the shelf paradigm without the need for blood or tissue typing.

About AlloCure

AlloCure, Inc. is a privately held, clinical-stage biotechnology company focused on the treatment of kidney disease. The company is a leader in the AKI field and is pioneering the development of the first effective therapy for the treatment of AKI. The companys headquarters is located in Burlington, MA. For more information about AlloCure, please visit the companys web site at http://www.allocure.com.

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AlloCure Begins Phase 2 Clinical Trial in Acute Kidney Injury

Cellerant Awarded $36.4 Million Option under Existing U.S. Government Contract to Support Development of CLT-008 for …

SAN CARLOS, Calif.--(BUSINESS WIRE)--

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has been awarded $36.4 million under an option exercised by the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services, for the advanced development of CLT-008, a first-in-class, allogeneic, cell-based therapy for the treatment of Acute Radiation Syndrome (ARS). This third year of funding is in addition to the $80 million committed under the two-year base period and is part of a five-year award valued at up to $169.9 million.

This additional funding will continue to support Cellerants CLT-008 development strategy by providing funds for its ongoing clinical trials, process development and manufacturing activities and the nonclinical studies required for approval in ARS. If licensed by the U.S. Food and Drug Administration (FDA), the federal government could buy CLT-008 for the Strategic National Stockpile under Project Bioshield. Project Bioshield is designed to accelerate the research, development, purchase and availability of effective medical countermeasures for the Strategic National Stockpile.

We are pleased that the federal government continues to support our biodefense efforts to advance CLT-008, said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. Our collaboration with BARDA over the past two years has been productive and this option exercise demonstrates BARDAs continued endorsement and satisfaction with the development and progress of CLT-008 as a potential medical countermeasure.

As part of BARDAs commitment to supporting multi-use products that have both commercial and biodefense applications, this third year of funding also allows Cellerant to continue its ongoing clinical trials with CLT-008 for cancer applications. Cellerants first Phase 1 study is evaluating CLT-008 in patients undergoing cord blood transplants for the treatment of hematological malignancies. CLT-008 is intended to rapidly produce neutrophils and platelets in vivo and facilitate long-term engraftment in patients undergoing bone marrow or cord blood transplantation. Cellerants second Phase 1/2 study is evaluating CLT-008 in acute leukemia patients with chemotherapy-induced neutropenia. CLT-008 may shorten the time to neutrophil recovery and decrease the risks of febrile neutropenia and infection.

In ARS applications, CLT-008 is intended to provide hematopoietic cellular support after exposure to ionizing radiation such as from a nuclear or radiological weapon, or from a nuclear accident. Various preclinical studies conducted to date suggest that a single dose of CLT-008 could provide effective treatment for ARS in an emergency situation, and could be administered up to five days post-exposure to radiation. CLT-008 is being developed under the U.S. Food and Drug Administrations Animal Efficacy Rule for ARS. This approval pathway requires demonstration of efficacy in representative animal models and safety and metabolism testing in human clinical trials. There is currently no FDA approved medical countermeasure to treat ARS.

About CLT-008

CLT-008 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human myeloid progenitor cells derived from adult hematopoietic stem cells that have the ability to mature into functional granulocytes, platelets and red blood cells in vivo. In preclinical models, cryopreserved, allogeneic mouse myeloid progenitor cells have been shown to be highly effective in providing protection from lethal radiation, preventing infection, facilitating stem cell engraftment and improving overall survival with a high degree of efficacy. Cellerant is developing CLT-008 as a treatment for chemotherapy-induced neutropenia, protection following exposure to acute radiation, and facilitating engraftment of cord blood transplantation.

About Cellerant Therapeutics

Cellerant Therapeutics is a clinical stage biotechnology company focused on the regulation of the hematopoietic (blood-forming) system. The Company is developing human stem cell and antibody therapies for oncology applications and blood-related disorders. Cellerants lead product, CLT-008, is currently in two Phase 1 clinical trials in patients with hematological malignancies. The Company also has a cancer stem cell (CSC) antibody discovery program focused on therapies for acute myelogenous leukemia, multiple myeloma and myelodysplastic syndrome.

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Cellerant Awarded $36.4 Million Option under Existing U.S. Government Contract to Support Development of CLT-008 for ...