Category Archives: FDA Stem Cell Trials

By Estel Grace Masangkay CardioCell LLC announced that it has received FDA approval for its investigational new drug (IND) application for a U.S.-based Phase IIA clinical study evaluating its allogeneic stem-cell therapy for patients with chronic heart failure (CHF). Dr. Sergey Sikora, CardioCells president and CEO, said, With the FDAs IND approval, CardioCell is pleased to proceed with a Phase 2a CHF clinical trial based on the safety data reported in previous clinical trials using our unique, hypoxically grown stem cells. At the studys conclusion we will understand if our therapy produces signs of improvement in a population of patients with dilated CHF, a condition largely unaddressed by current therapies. Dilated CHF is characterized by a viable but non-functioning myocardium in which cardiomyocytes are alive but are not contracting as they should. We hope that unique properties of our itMSCs will transition patients cardiomyocytes from viable to functioning, eventually improving or restoring heart function. The company has developed an ischemic tolerant mesenchymal stem cells (itMSC) treatment for the type of dilated CHF that is not related to coronary artery disease. The treatment could potentially apply to about 35 percent of CHF patients. Only CardioCells CHF therapies feature itMSCs, exclusively licensed … Continue reading →

CardioCell LLC has just received the FDAs investigational new drug (IND) approval for a United States-based, Phase 2a clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than one million hospitalizations annually. Preparation is underway to initiate the study, A Phase 2a, Single-Blind, Placebo-Controlled, Crossover, Multi-Center, Randomized Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-Tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-Ischemic Etiology, at Emory University, Northwestern University and the University of Pennsylvania in May 2014. With the FDAs IND approval, CardioCell is pleased to proceed with a Phase 2a CHF clinical trial based on the safety data reported in previous clinical trials using our unique, hypoxically grown stem cells, said Dr. Sergey Sikora, CardioCells president and CEO. At the studys conclusion we will understand if our therapy produces signs of improvement in a population of patients with dilated CHF, a condition largely unaddressed by current therapies. Dilated CHF is characterized by a viable but non-functioning myocardium in which cardiomyocytes are alive but are not contracting as they should. We hope that unique properties of our itMSCs will … Continue reading →

By Estel Grace Masangkay CardioCell LLC announced that it has received FDA approval for its investigational new drug (IND) application for a U.S.-based Phase IIA clinical study evaluating its allogeneic stem-cell therapy for patients with chronic heart failure (CHF). Dr. Sergey Sikora, CardioCells president and CEO, said, With the FDAs IND approval, CardioCell is pleased to proceed with a Phase 2a CHF clinical trial based on the safety data reported in previous clinical trials using our unique, hypoxically grown stem cells. At the studys conclusion we will understand if our therapy produces signs of improvement in a population of patients with dilated CHF, a condition largely unaddressed by current therapies. Dilated CHF is characterized by a viable but non-functioning myocardium in which cardiomyocytes are alive but are not contracting as they should. We hope that unique properties of our itMSCs will transition patients cardiomyocytes from viable to functioning, eventually improving or restoring heart function. The company has developed an ischemic tolerant mesenchymal stem cells (itMSC) treatment for the type of dilated CHF that is not related to coronary artery disease. The treatment could potentially apply to about 35 percent of CHF patients. Only CardioCells CHF therapies feature itMSCs, exclusively licensed … Continue reading →

While donation-based crowdfunding has taken some industries, like consumer technology, by storm, its been dismissed by some as a source of early-stage life science funding because of the sky-high price tag that biotech and medical device R&D carries. Raising a few thousand dollars wont really do much to get a company off the ground. But a few recent campaigns are challenging that idea, pulling in more than $100,000 in donations through Indiegogo. The latest is Tisch MS Research Center, a nonprofit research center in New York thats so far collected more than $243,000 for a Phase 1 clinical trial of a stem cell treatment for multiple sclerosis. Tisch researchers have gotten the green light from the FDA to proceed with a safety and tolerability study of a treatment it says has the potential to reverse damage done by MS. The autoimmune disease attacks the protective coating of axons (the myelin sheath) in the brain and spinal cord, disrupting the ability of nerve signals to travel properly. That can cause numbness, pain, vision loss, difficulty walking and even paralysis. Stem cells are hypothesized to promote repair in MS by migrating to areas of demyelination, blocking damage-forming events and enabling repair, Tisch … Continue reading →

REPAIR, REGENERATE & RENEW: Cutting-Edge Stem Cell Research at Tisch MS Research Center of New York In 2013, Tisch MSRCNY made stem cell science history. Our adult stem cell treatment received FDA approval for a Phase I Clinical Trial that has the potential to repair the damage caused by MS. This exciting milestone took over ten years to reach and brings indescribable hope to MS patients and their loved ones all over the world. Our stem cell therapy is the star of the research program at the Tisch MS Research Center of New York (Tisch MSRCNY), a 501(c)(3), independent, non-profit research center dedicated to finding the cause of and cure for multiple sclerosis (MS). The Center focuses on patient-based research, bringing findings rapidly from the laboratory into clinical application to treat symptoms of MS and to halt or reverse damage caused by the disease. From our preclinical models, we know that stem cells injected into the spinal fluid can have significant benefit in terms of improved neurological symptoms. Continue reading here: Tisch MS Center's FDA-Approved Phase I Stem Cell Trial for ... … Continue reading →

Contact Information Available for logged-in reporters only Newswise MADISON, Wis. Desperate patients are easy prey for unscrupulous clinics offering untested and risky stem cell treatments, says law and bioethics Professor Alta Charo of the University of Wisconsin-Madison, who is studying stem cell tourism. Stem cells are cells that can form many types of cells in the body, and that makes them inherently promising and dangerous. Stem cell tourism refers to people traveling, both within the U.S. and abroad, in pursuit of advertised stem cell therapies to purportedly treat a variety of medical conditions. The evidence for therapeutic use of stem cells is very limited, except for bone marrow stem cells, but patients all over the world are convinced stem cells will cure their disease, says Charo. While there are some very promising results in the early clinical trials for stem cell therapies using embryonic and other kinds of stem cells, the treatments being advertised by these clinics are dubious, mostly ineffective, and sometimes positively harmful. Patients are being hoodwinked, but there are dilemmas about tackling (the treatments) at regulatory or political levels. The outrage over failures in stem cell tourism is limited, Charo says. Patients may pay tens of thousands … Continue reading →

A company that goes 24 years without ever selling a product may sound unusual. But in biotechnology, it's not that uncommon. Take Geron Corp. in Menlo Park, which has struggled to develop a therapy -- any therapy -- since its founding in 1990. The company first focused on spinal cord injuries but later moved to various cancers. This month, the Food and Drug Administration halted clinical trials for its only drug. The pharmaceutical industry has never been known for speed. All therapies must undergo years of clinical trials to meet the FDA's standards for safety and efficacy. Faced with 10- to 15-year timelines and uncertain regulatory outcomes, companies and investors might plow hundreds of millions of dollars into therapies that will never see the light of day. While the FDA says the process ensures drugs are effective and safe, some doctors, scientists, companies and advocates see it as a bureaucratic slog that keeps promising treatments from dying patients. A dozen California academic medical centers and hospital systems recently teamed up to tweak a key part of trials: the ethics review board. This committee of independent experts monitors human subjects' rights during trials. Under the new Partnership to Accelerate Clinical Trials, … Continue reading →

FDA weighs possibility of allowing research into three-parent babies By Dennis Sadowski Catholic News Service WASHINGTON (CNS) -- Fertilization techniques that would create babies from the DNA of three or four people to prevent the transmission of inheritable genetic diseases are being questioned by ethicists and others who say the procedures fail basic ethical and moral standards. Chief among the concerns is that the techniques, which involve replacing a mother's mitochondria with that of an egg donor, would pass on genetic alterations with unknown implications for future generations. The techniques are controversial because they involve altering an embryo's DNA, leading to questions about whether the government should approve the creation of, in effect, genetically modified humans. In addition, the techniques rely upon in vitro fertilization, which the Catholic Church has long opposed as immoral. In IVF, a woman's eggs are removed, united with sperm in a laboratory, and then implanted in the womb of the mother or a surrogate. The two forms of the technology to overcome mitochondrial disease -- maternal spindle transfer and pronuclear transfer -- were discussed during a hearing called by the Cellular, Tissue and Gene Therapies Advisory Committee of the Food and Drug Administration Feb. 25-26. … Continue reading →

IRVINE, Calif. (February 18, 2014) California Stem Cell, Inc. (CSC) announced today that the U.S. Food and Drug Administration (FDA) has approved the Companys application to begin a Phase II clinical trial exploring the potential of a patient-specific cancer immunotherapy in women with Stage III or IV ovarian, fallopian tube or primary peritoneal cancer. The randomized, double-blind study is the Companys second cancer therapy approved for clinical trials by FDA, bolstering its platform approach to treating late stage solid-tumor cancers. The Companys patient-specific approach to treating metastatic melanoma, recently approved to begin a Phase III trial, provided sufficient safety data to proceed directly to a Phase II study in ovarian 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 patients 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, harvested … Continue reading →

By RTT News, March 05, 2014, 12:08:00 AM EDT (RTTNews.com) - Argos Therapeutics Inc. ( ARGS ) touched a new high of $12.55 on Tuesday before closing at $12.30 following new positive findings from a completed phase IIa clinical trial of AGS-004 for the treatment of HIV infection. AGS-004 has been found to induce anti-HIV T memory stem cell-like immune responses in chronic HIV patients and these responses are associated with viral load control in the absence of ART (Antiretroviral Therapy) drugs, said the company. According to the company website, in an ongoing phase IIb clinical trial of AGS-004 enrollment is complete, and results are expected in the second quarter of 2014. Atossa Genetics Inc. ( ATOS ) dropped 11.32% to $1.88 following FDA's request for additional information related to 510(k) application for ForeCYTE Breast Aspirator. The company submitted a Premarket 510(k) Notification with the FDA seeking clearance of the ForeCYTE Breast Aspirator, including the ForeCYTE breast pump and patient collection kit, which are intended for use in the collection of nipple aspirate fluid for laboratory cytological testing last December. Now that the regulatory agency has asked for additional information, Atossa plans to request an extension to the 30 day … Continue reading →