Category Archives: FDA Stem Cell Trials

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San Francisco, California (PRWEB) December 17, 2013 As people age, the cheek area loses volume, making the cheeks flatten out and the skin droop and sag. Juvaderm Voluma XC, just approved by the FDA, is the first and only filler approved to correct age-related volume loss in the cheek area. This product will change the way we address facial aging and contouring, says Dr. Maas. It instantly provides smooth, natural-looking results that last up to two years with optimal correction. With the FDA approval of Juvaderm Voluma XC, physicians and patients in the U.S. now have a new treatment option that can help create a natural-looking, more youthful appearance in the cheek area. A very real alternative to surgical fat grafting or fat transfer sometimes referred to as stem cell facelift. Dr. Maas welcomes the opportunity to discuss why and how the face loses volume as people age. I can also speak about how Juvaderm Voluma XC is an effective non-surgical treatment option for age-related volume loss in the cheek area. Side effects are moderate (uncomfortable) and generally last 2 to 4 weeks. The most common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, … Continue reading →

Celgene Cellular Therapeutics Receives FDA Clearance for First Placenta-Derived Stem Cell Clinical Study -- Trial is First Application of Company's Proprietary Cell Therapy Product-- WARREN, N.J.--(BUSINESS WIRE)--Celgene Cellular Therapeutics (CCT), a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced the U.S. Food and Drug Administration (FDA) has accepted the company's investigational new drug application to initiate a clinical trial using PDA001, an immunomodulatory therapy utilizing human placenta-derived stem cells obtained via CCT's proprietary processes. Clinical development will begin by the end of the year with the initiation of this Phase I, multi-center clinical trial in the U.S. for patients with moderate-to-severe Crohn's disease, who are refractory to oral corticosteroids, such as prednisone, and immune suppressants. PDA001 is a novel culture expanded stem cell population that has broad therapeutic potential in areas such as immunology, inflammation, hematology and oncology. Pre-clinical evaluation of PDA001 has demonstrated its safety and potent immune-suppressive properties. A placenta-derived stem cell therapy, PDA001 has several potential significant benefits in that the cells are derived from a safe and almost unlimited source and are scalable to a traditional pharmaceutical level. CCT owns an array of proprietary technologies directed to novel placental cell types and cell populations, … Continue reading →

By Mary Ann Chirba, J.D., D.Sc., M.P.H. and Alice A. Noble, J.D., M.P.H. Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This months announcement of a cloned human embryo from a single skin cell [1] came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanakas receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use. Less controversial are multipotent adult stem cells (ASCs) which do not involve embryos … Continue reading →

A groundbreaking attempt to heal eight Parkinson's patients with their own cells could move from research to the clinic next year. For eight Parkinson's patients seeking treatment with a new form of stem cell therapy, 2014 promises to be a milestone. If all goes well, next year the FDA will give approval to begin clinical trials. And if the patients can raise enough money, the scientists and doctors working with them will have the money to proceed. Jeanne Loring, a stem cell scientist at The Scripps Research Institute, discusses the status of a project to treat Parkinson's patients with their own cells, turned into the kind of brain cells destroyed in Parkinson's. The project is a collaboration with Scripps Health and the Parkinson's Association of San Diego. Scientists at The Scripps Research Institute led by Jeanne Loring have taken skin cells from all patients and grown them into artificial embryonic stem cells, called induced pluripotent stem cells. They then converted the cells into dopamine-making neurons, the kind destroyed in Parkinson's disease. Loring discussed the project's progress on Friday morning at the 2013 World Stem Cell Summit in San Diego. If animal studies now under way and other requirements are met, … Continue reading →

IRVINE, Calif. 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 III clinical trial exploring the potential of a cancer stem cell-based platform therapy to treat advanced metastatic melanoma. The protocol has received Special Protocol Assessment (SPA), indicating that FDA is in agreement that the design, clinical endpoints, and planned clinical analyses of the Phase III trial address regulatory objectives sufficient for market approval. The therapy has also been granted fast track status by FDA, a designation given to therapies which show promise in treating life-threatening medical conditions, which accelerates the approval of investigational new drugs undergoing clinical trials. The study, to be led by Robert Dillman, M.D., F.A.C.P., medical oncologist at the Hoag Family Cancer Institute of Hoag Memorial Hospital Presbyterian, calls for enrolling 250 patients with recurrent Stage III or Stage IV metastatic melanoma in a multi-centered, randomized, double-blind study that compares overall survival of patients who receive CSCs patient-specific cancer immunotherapy, known as DC-TC, against patients receiving a control treatment. CSC's "DC-TC" therapy begins with cancer stem cells that have been isolated from a patient's resected tumor sample, enriched and inactivated. This … Continue reading →

Oct 22, 2013 What can we expect from the first U.S. human clinical trials of stem cell therapy for spinal cord injury (SCI)? In an exciting development, StemCells, Inc., has announced that it has received FDA authorization to begin clinical trials of its Investigational New Drug (IND) application of purified stem cell therapy to treat chronic spinal cord injury. This means that the breakthrough therapy for stem cell injuries can now begin testing on human patients in the United States. The company, which focuses on the research and development of therapies and tools for use in stem-cell-based research, began trials about a year ago in Switzerland and Canada, and sees the potential breakthrough therapy currently being tested on a total of seven patients in those countries. The company calls the therapy HuCNS-SC, which stands for human neural stem cells. Research for the therapy has been ongoing since 2002, when pre-clinical studies conducted with researchers at the University of California, Irvine showed that human neural stem cells engraft long-term, migrate to the area of injury, and transform themselves into specialized cells that create the protein myelin, a vital substance in treating spinal cord injury. The research eventually showed that transplantation of … Continue reading →

The Tisch MS Research Center of New York has received IND approval from the FDA to commence a phase I trial using autologous neural stem cells in the treatment of multiple sclerosis (MS). MS is a chronic human autoimmune disease of the central nervous system that leads to myelin damage and neurodegeneration and affects approximately 2.1 million people worldwide. "To my knowledge, this is the first FDA-approved stem cell trial in the U.S. to investigate direct injection of stem cells into the cerebrospinal fluid of MS patients, and represents an exciting advance in MS research and treatment," said Dr. Saud A. Sadiq, senior research scientist at Tisch MS Research Center of New York and the study's Principal Investigator. The study will investigate a regenerative strategy using stem cells harvested from the patient's own bone marrow.These stem cells will be injected intrathecally (into the cerebrospinal fluid surrounding the spinal cord) in 20 participants who meet the inclusion criteria for the trial. This will be an open label safety and tolerability study.All study activities will be conducted at the Tisch MS Research Center and affiliated International Multiple Sclerosis Management Practice (IMSMP). The clinical application of autologous neural progenitors in MS is the … Continue reading →

Wednesday's Child This Kid With A Big Heart Hopes To Find Forever Family This Kid With A Big Heart Hopes To Find Forever Family Born in 2000, Timothy is a kid with many interests and a big heart. He's all about sports, especially baseball, and is a Dodgers fan. Born in 2000, Timothy is a kid with many interests and a big heart. He's all about sports, especially baseball, and is a Dodgers fan. Updated: Monday, December 2 2013 12:19 PM EST2013-12-02 17:19:50 GMT This week in Gina's People it's all about music. Our FOX 11 viewer, Jack Ramsey goes out of his way to help patients at Torrance Memorial Medical Center feel like they are at a concert hall. This week in Gina's People it's all about music. Our FOX 11 viewer, Jack Ramsey goes out of his way to help patients at Torrance Memorial Medical Center feel like they are at a concert hall. Updated: Friday, November 29 2013 12:30 AM EST2013-11-29 05:30:54 GMT GOING GREEN: The Chevy Spark EV is a much more entertaining driver than the standard gasoline model, largely due to the huge electric torque on tap. GOING GREEN: This years LA Auto Show is … Continue reading →

Article Highlights: Maryland biotherapeutics company Neuralstem today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a phase 2 clinical trial to test its NSI-566 neural stem cells in people with amyotrophic lateral sclerosis (ALS). Neural stem cells generate muscle-controlling nerve cells (motor neurons) and glia (a type of motor neuron support cell) in the brain. It's hoped the experimental therapy will improve respiratory function and prolong life in ALS. The trial, which is designed to assess safety and determine the maximum-tolerated dose, will expand to two centers: Investigators expect to enroll 15 participants, who will be divided into five different dosing groups. The first 12 participants will receive stem cell injections into the cervical (neck) region of the spinal cord. The last three participants will receive injections in both the cervical and lumbar (lower back) regions of the spinal cord. In addition to other eligibility criteria, participants must be ambulatory, and must live within close geographic proximity to the research center at which they will participate. "The aim of this phase 2 trial is to obtain the maximum-tolerated dose using the same route of administration as in phase 1, which was through … Continue reading →