Category Archives: Stem Cell Human Trials

NEWARK, Calif., Sept. 6, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that the California Institute for Regenerative Medicine (CIRM) has approved an award to the Company for up to $20 million under CIRM's Disease Team Therapy Development Award program (RFA 10-05). The award is to fund preclinical development of StemCells' proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) in Alzheimer's disease over a maximum four-year period, with the goal of filing an investigational new drug (IND) application for a clinical trial in that time. In July, CIRM approved a separate award to the Company under RFA 10-05 for up to $20 million to fund preclinical development of HuCNS-SC cells in cervical spinal cord injury. "With the recent spate of late-stage clinical failures in Alzheimer's disease, it is clear that the field could benefit from alternative approaches to lessen the huge burden on families, caregivers and our healthcare system," commented Martin McGlynn, President and CEO of StemCells, Inc. "Our recently reported preclinical data, which showed that our neural stem cells restored memory and enhanced synaptic function in two animal models relevant to Alzheimer's disease, shows our approach has promise. We greatly appreciate the support from CIRM, which should … Continue reading →

Company name: Fate Therapeutics. Industry: regenerative medicine. Location: San Diego, California. Money raised: $9.2 million in equity from 17 investors. How it will be used: Chief financial officer Scott Wolchko didnt return a call. According to a press release from December, the company saw positive results in a phase 1 trial of ProHema in patients who underwent double umbilical cord blood transplants following treatment for blood cancers. The company is also exploring the use of ProHema in other HSC transplant settings. According to clinicaltrial.gov, two additional studies are in the works. Investors: Previously, Fate has raised $50 million in series A and B rounds from Takeda Ventures, ARCH Venture Partners, OVP Venture Partners, Polaris Venture Partners, Venrock, Astellas Venture Management and Genzyme Ventures. Management team: CEO William Rastetter is a partner at Venrock. Formerly, he was CEO of Idec Pharmaceuticals and became executive chairman of Biogen Idec when the two companies merged in 2003. Before that, he was the director of corporate ventures at Genentech. Pratik Multani, senior vice president of clinical development, advanced the development of several compounds in clinical development leadership positions at Kalypsys Inc., Kanisa Pharmaceuticals, Salmedix and Biogen Idec. Market opportunity: More than 100,000 cases of … Continue reading →

GAITHERSBURG, MD--(Marketwire -09/05/12)- Cytomedix, Inc. (CMXI), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Company's AutoloGel System will be highlighted in an oral abstract and a poster presentation at the 4th Congress of the World Union of Wound Healing Societies (WUWHS 2012) being held from September 2-6, in Yokohama, Japan. The AutoloGel System is a device for the production of autologous platelet rich plasma ("PRP") gel, and is the only PRP device cleared by the U.S. Food and Drug Administration ("FDA") for use in wound management. "The Impact of Autologous Platelet Rich Plasma (PRP) Gel on Chronic Wounds" will be presented September 5th from 3:00 to 4:30 p.m. JST as part of the Tissue Engineering and Regenerative Medicines in Wound Healing session. The poster, OR 206, will be presented by Laura Parnell, MSc, CWS, Precision Consulting on behalf of Carelyn P. Fylling, RN, MSN, CWS, CLNC, Vice President of Professional Services of Cytomedix and lead author on the poster. Key Study Findings (all data reflects mean outcomes) The study concluded that AutoloGel PRP Gel "initiated rapid size reduction in long-standing non-healing wounds of … Continue reading →

CLEVELAND, Ohio -- One of the most promising and exciting treatment avenues for multiple sclerosis is the use of a patient's own stem cells to try to stop -- or even repair -- some of the disease's brain tissue damage. But injecting a patient with a dose of his or her own bone-marrow stem cells was actually a pretty crude method of treating the disease, because no one was quite sure how or why it worked. Last year, doctors at the Cleveland Clinic, University Hospitals Seidman Cancer Center and Case Western Reserve University began trying this for MS patients in a Phase 1 clinical trial after positive results were seen in mice. Multiple sclerosis is an autoimmune disease in which the immune system attacks the myelin sheaths that surround and protect nerve cells. When myelin is damaged, the nerve cells are exposed and unable to do their job, which is sending signals to the brain and back. This results in the loss of motor skills, coordination and cognitive abilities. Like many other researchers using stem cells, the local group didn't know exactly how their treatment worked, but they knew that when they gave these human mesenchymal stem cells, or MSCs, … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that its chief scientific officer, Robert Lanza, M.D., will be delivering the opening Keynote Speech at the 4th Annual Stem Cell Symposium 2012, being held in Singapore, September 6-7. Dr. Lanzas presentation is titled Pluripotent Stem Cells From Benchtop to Clinic. With the theme, Stem Cell Based Therapy, the symposium will have a particular focus on clinical trials and industrial application of stem cells. Sponsored by Stem Cell Society of Singapore (SCSS), the conference will include scientific presentations from key contributors from academic, clinical, and commercial organizations who are translating basic research on stem cells into therapeutics, with a focus on applying engineering technologies to provide medical solutions. In their opening statement, the organizers state, We are all keeping our fingers crossed for ACTs success, which will also bring a big boost to the stem cell community. Other topics of the conference include human induced pluripotent stem cells (hiPSCs), drug screening, adult and cancer stem cells, and stem cell therapies emerging from Asia, with presentations from Indian, Korean and Japanese regenerative medicine companies. There will also be a joint session … Continue reading →

NEWARK, Calif., Sept. 3, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that interim six-month data from the first patient cohort in the Company's Phase I/II clinical trial of its proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) for chronic spinal cord injury continues to demonstrate a favorable safety profile, and shows considerable gains in sensory function in two of the three patients compared to pre-transplant baselines. The third patient remains stable. The data was presented by Armin Curt, M.D., principal investigator for the clinical trial, at the 51st Annual Scientific Meeting of the International Spinal Cord Society in London, England. The trial represents the first time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury. "As with the three-month assessments, these three patients have tolerated the cell transplantation very well, and we have no safety concerns at this point," said Dr. Curt, Professor and Chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich. "We are very intrigued to see that two of the three patients have gained considerable sensory function. The gains in sensation have evolved in a progressive pattern below the level of injury … Continue reading →

NEWARK, Calif., Aug. 30, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that Armin Curt, MD, Professor and Chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich, and principal investigator for the Company's Phase I/II clinical trial in chronic spinal cord injury, will make an oral presentation on the progress of the trial on Monday, September 3 at the 51st Annual Scientific Meeting of the International Spinal Cord Society (ISCOS), which is being held in London, England, on September 3-5, 2012. In his presentation, Dr. Curt will present six-month interim data from the first patient cohort in the trial. The three patients in the first cohort all have thoracic (chest-level) spinal cord injury classified as AIS A, in which there is no neurological function below the injury level. The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function. In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor function and bowel/bladder function. The trial is being conducted at Balgrist University Hospital, … Continue reading →

After Stifel Nicolaus initiated a Buy rating on Geron Corporation (GERN) Thursday morning, shares are up 10% to $2.68. The $4 target price initially created 13% gains after the open, but shares have declined slightly as traders take profits off the top. The move marks a 2012 high for Geron since it cancelled its stem cell program in November in favor of a focus on oncology drugs. The company develops Imetelstat, a telomerase inhibitor in Phase 2 trials, and GRN1005 which is entering Phase 2 studies for brain metastases. Imetelstat, the company`s lead compound, is in trials evaluating the drug as a maintenance therapy for metastatic breast cancer, advanced non-small cell lung cancer, essential thrombocythemia and multiple myeloma. It completed enrollment for the NSCLC trial in May and hopes to have top-line data before the end of the year as well as top-line data from the metastatic breast cancer trial in 1Q of 2013. Investors are anxious to learn more about how the discontinuation of Geron`s stem cell program will affect the company`s balance sheet, and whether the cell therapies could still hold long-term value. The program was using embryonic cells to treat spinal cord injuries and had begun FDA-approved … Continue reading →

MADISON, Wis., Aug. 28, 2012 /PRNewswire/ --Novelos Therapeutics, Inc. (NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that it is developing CLR1502 (GLOW2), a preclinical cancer-targeted optical imaging agent for intraoperative tumor margin illumination and non-invasive tumor imaging. GLOW2 is expected to facilitate and enable diagnostic, staging, debulking and curative cancer surgeries intraoperatively in real time. Novelos expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for GLOW2 in the second half of 2013 and begin clinical trials shortly thereafter. "Current imaging modalities are extremely limited in their ability to define tumor margins, thus contributing to the unacceptably high rate of incomplete surgical removal of malignant tissue, which is associated with an increased risk of cancer recurrence," said Sharon Weber, M.D., Professor and Chief of Surgical Oncology, Vice Chair of Academic Affairs for General Surgery, University of Wisconsin Department of Surgery, and Director of Surgical Oncology, Carbone Cancer Center. "The potential for GLOW2 to provide surgeons with more accurate visualization of tumor margins during surgery could result in more complete and selective removal of tumors and significantly improve patient outcomes. I am excited to … Continue reading →

A cure for spinal cord injury? Diabetes? Macular degeneration? Hope or just hype? There are now some clinical trials using embryonic stem cells to treat serious diseases for which no other good therapy is currently available. But this is just the beginning of a major medical megatrend that will blossom forth in the coming years. Embryonic stem cells are present after a fertilized egg divides for two or three days. They have the seemingly miraculous ability to turn into any of the tissue types in the bodywhether brain neurons, beating heart cells, bone, or pancreatic islet cells. It is important to understand just where these cells come from. Those used in science are the byproduct of in vitro fertilization (IVF), cells taken from the often left over embryos that are otherwise discarded. In 1998, scientists under the leadership of Dr James Thomson at the University of Wisconsin, learned how to take some of the cells from these about to be discarded embryos and put them into a cell culture basically a fluid in which the cells can grow to produce more cells. These cells in turn can then be directed to grow into heart or lung or pancreas or other … Continue reading →