by Dan Browning A decade-long Mayo Clinic research project on using stem cells to repair damaged heart tissue has won federal approval for human testing, a step that could have implications for millions of Americans with heart disease. The U.S. Food and Drug Administration has approved a multistate clinical trial of 240 patients with chronic advanced symptomatic heart failure to see if the new procedure produces a significant improvement in heart function, Mayo officials announced Friday. Safety testing in humans, completed earlier in Europe, showed a preliminary 25 percent improvement in cardiac outflow, according to Dr. Andre Terzic, director of the Mayo Clinic's Center for Regenerative Medicine. The procedure could be a "paradigm shift" in the treatment of heart disease, Terzic said. Going forward, he said, treatments won't just focus on easing the symptoms of heart disease, but rather on curing it. The process, developed in collaboration with Cardio3 BioSciences of Belgium, involves harvesting stem cells from a patient's bone marrow in the hip, directing the cells to become "cardiopoietic" repair cells, then injecting them back into the heart to do their work. Mayo researcher Dr. Atta Behfar and other members of Terzic's team isolated hundreds of proteins involved in … Continue reading →

A research project undertaken by the Mayo Clinic for nearly a decade has finally won approval from the U.S. Food and Drug Administration (FDA) to go ahead with testing on humans. The research project involves using stem cells to fix damaged heart tissue, and this step forward is a hopeful sign for millions of people who live with heart disease. The clinical trial will be carried out across several states and will involve 240 patients with chronic advanced symptomatic heart failure. It will help researchers discern whether the stem cell technique will make a marked improvement in heart function, the Mayo Clinic announced last week. The trial will probably take until the end of the year. Previously, Mayo had completed some testing in humans in Europe, which showed promising results a 25 percent improvement in cardiac outflow, Dr. Andre Terzic, director of the Mayo Clinics Center for Regenerative Medicine, said. Terzic called the technique a potential paradigm shift. The technique involves the harvesting of stem cells from a persons bone marrow in the hip, altering the cells to become cardiopoietic repair cells, and then injecting them into the heart to do their fixing work. The procedure was developed with help … Continue reading →

Israel's Pluristem Therapeutics ($PSTI) is back in the spotlight with some positive results for its stem cell therapy in treating patients with a muscle injury, giving the biotech some good news in its up-and-down development path. In the Phase I/II trial, Pluristem injected its placenta-derived stem cell therapy into patients who suffered gluteus muscle injuries during hip replacement surgery. Using muscle contraction force as an efficacy endpoint, the study found that patients who got a 150-million-cell dose of Pluristem's drug posted a 500% improvement over placebo, while those on a 300-million-cell dose beat out the control arm by 300%. The study met its safety endpoint, as well, the company said. The treatment, dubbed PLX-PAD, also had a significant effect on muscle volume, Pluristem said, suggesting a bright future for the stem cell therapy in repairing other injuries, CEO Zami Aberman said. "This was a very important study not only for Pluristem but for the cell therapy industry in general," Aberman said in a statement. "... Based on these results, we intend to move forward with implementing our strategy toward using PLX cells in orthopedic indications and muscle trauma." The company's shares jumped about 5% to $4.60 on the news, their … Continue reading →

Orphan Drug Designation is granted to therapeutics intended to treat rare diseases that affect not more than 200,000 people in the United States. Orphan Drug Designation entitles the sponsor to a seven-year marketing exclusivity period, clinical protocol assistance with the FDA, as well as federal grants and tax credits. The Orphan Drug Designation was granted for use of BL-8040, in combination with granulocyte colony-stimulating factor (G-CSF), to mobilize human stem cells from the bone marrow to the peripheral blood for collection for autologous or allogeneic (donor-based) transplantation. "We are very pleased to have our second Orphan Drug Designation for BL-8040, in this case for stem cell mobilization treatment, after already having received the designation last year for the treatment of acute myeloid leukemia," stated Dr. Kinneret Savitsky, chief executive officer of BioLineRx. "This is in line with our 2014 development plan for BL-8040, which includes clinical studies for both AML and stem cell mobilization. BL-8040 was already shown to be highly effective in mobilizing stem cells in combination with G-CSF in a Phase 1/2 study in multiple myeloma patients, and initial results of BL-8040's Phase 2 study for AML patients indicate that BL-8040 on a stand-alone basis triggers substantial mobilization … Continue reading →

IRVINE, Calif.--(BUSINESS WIRE)--California Stem Cell, Inc. (CSC) announced today it has submitted a Phase II protocol to the U.S. Food and Drug Administration for a randomized, double-blind study to evaluate CSCs patient-specific cancer immunotherapy in women with Stage III or IV ovarian, fallopian tube or primary peritoneal cancer. Led by Chief Medical Officer Robert Dillman, M.D., the study design randomizes an estimated 99 adult female patients to two treatment arms. The treatment group will receive Ovapuldencel-T, which is a combination of autologous dendritic cells loaded with irradiated autologous tumor cells in GM-CSF. Ovapuldencel-T is created by first isolating cancer stem cells from the patient's resected tumor sample, then enriching, inactivating and combining these cells with dendritic cells or antigen-presenting immune cells which are harvested from the patients blood. The control group will receive the MC treatment, which involves harvesting the patients blood (autologous peripheral blood mononuclear cells) and combining it with GM-CSF, granulocyte-macrophage colony-stimulating factor, a white blood cell growth factor. The trial design calls for both groups to receive subcutaneous injections of their respective treatment weekly for three consecutive weeks, then monthly for the following five months. The trial, which will be conducted at Hoag Hospital Presbyterian in Newport … Continue reading →