Category Archives: FDA Stem Cell Trials

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 →

Umbilical cord stem cell banking can be expensive and controversial, but Jamie and Ben Page decided to bank their daughter, Harlow's stem cells just in case. "We had heard about cord blood banking and talked about it a lot and thought let's just go for it and have it just as a backup," Jamie Page said. They did need it. Harlow had cancer in her uterus. "On the ultrasound they immediately saw that there was a mass in her abdomen about the size of a grapefruit," Page said. After a year of chemo, the tumor was gone. Doctors wanted to keep it that way. "So, when the doctors found out we actually had her own stem cells, they were very excited," Page said. Oncologist Elaine Morgan says those stem cells helped Harlow. "I think that her umbilical cord cells were used as a boost to her own cells when we harvested her to have adequate cells for reconstitution," Dr. Morgan said. Dr. Morgan does not advocate private cord stem cell banking at birth to be saved for a healthy baby's later use, because it's not clinically useful and it's expensive. The Pages paid almost $2,000 for the initial banking fee, … Continue reading →

Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact pressreleases@worldnow.com. SOURCE Cord Blood Registry Signals Potential of Newborn Stem Cells in Regenerative Medicine for Common Disorders SAN BRUNO, Calif., Jan. 16, 2014 /PRNewswire-USNewswire/ --Cord Blood Registry (CBR), the world's largest and most experienced newborn stem cell company, announces the start of a U.S. Food and Drug (FDA)-regulated study being conducted at Florida Hospital for Children in Orlando to investigate the use of a child's stem cells from their own stored umbilical cord blood as a treatment for acquired sensorineural hearing loss. (Logo: http://photos.prnewswire.com/prnh/20131216/DC33657LOGO-a) In the United States, approximately 15 percent of children suffer from low or high-frequency hearing loss.[i] The most common type of hearing loss, especially at high frequencies, is sensorineural. Acquired sensorineural hearing loss results from damage to hair cells in the inner ear (cochlea) and can be caused by illness, medication, noise exposure, birth injury, or head trauma. A child's ability to hear affects the development of language skills, and hearing impairments can lead to poor academic and social … Continue reading →

The trial, supported by CBR, follows promising evidence from preclinical studies suggesting that the infusion of human umbilical cord stem cells may help repair damaged cells in the inner ear in ways that could lead to hearing improvement.[iii] "As more children survive premature birth, we are observing increasing numbers of very young children with significant acquired hearing loss, and currently there are no therapies available for reversing that damage," says Linda Baumgartner M.S., CCC-SLP, LSLS cert. AVT, the trial's Speech and Language Pathologist and hearing loss expert. James Baumgartner, MD, Surgical Director of Florida Hospital for Children's Comprehensive Pediatric Epilepsy Center and the study's principal investigator notes that "presently, the only treatment options for acquired sensorineural hearing loss are hearing aids or cochlear implants, neither of which actually repairs the damage. Using cord blood stem cells to help trigger the body's own repair mechanisms could provide a non-invasive therapeutic option that does not exist today." During the last 25 years, cord blood stem cells have been used in more than 30,000 transplants performed worldwide for the treatment of nearly 80 serious diseases and disorders in both adults and children. The evolution of stem cell therapies has paved the way for … Continue reading →

FDA Approves Stem Cell Clinical Trial For Multiple Sclerosis NEW YORK, Aug. 14, 2013 /PRNewswire/ -- The Tisch MS Research Center of New York announced today that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) to commence a Phase 1 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 United States 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 groundbreaking 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. … Continue reading →

Welcome to this week's Biotech Stock Mailbag. Before I kick off, a few housekeeping items to note: I launched a new blog on TheStreet this week. It's called Adam's Biotech Beat. I know, not the most original name but straightforward. I'll have more to say about the blog later, but please bookmark the page and check it often. You'll see me posting a lot of intraday news and analysis, plus it's a great way to keep track of all my tweets. The J.P. Morgan Healthcare Conference starts Monday in San Francisco. I'm flying out there Sunday and will be providing live coverage from the presentations and breakout rooms. Chelsea Therapeutics (CHTP) and its hypotension drug Northera will be the star of an FDA advisory panel on Tuesday. I have invited healthcare investor and TheStreet contributing writer Aafia Chaudhry to live-blog the Chelsea panel, so please tune into that. More: Biotech Stock Mailbag: NeoStem, MannKind, Inovio … Continue reading →

FSMA-Funded Stem Cell Research Click here for a summary article in Regenerative Medicine on the potential of Stem Cell Therapy for ALS & SMA. Current Project Status: -In 2010, California Stem Cell, Inc submitted an IND application to the FDA for MotorGraft to begin clinical trials in infants with SMA. Please click here for the announcement. -In 2011, the FDA placed the MotorGraft Program on clinical hold, in order to obtain additional data. Please click here for the announcement. The filing of an IND application is the first step in a long, complicated process aimed ultimately at approval of a new therapy. A clinical hold is an order issued by the FDA to a sponsor to delay a proposed trial to obtain more data. California Stem Cell is actively working on collecting the new data requested by the FDA. Please click here for more on the clinical trial process. Past Program Milestones: -The Kerr lab publishes studies showing motor neurons from mouse embryonic stem cells provided therapeutic benefit in a rodents. Please click here for the paper. -Production of motor neurons from human embryonic stem cells are published (See Figure 1). The product is called MotorGraft. Please click here for … Continue reading →

(PRWEB) December 20, 2013 Florida Hospital Pepin Heart Institute and Dr. Kiran C. Patel Research Institute announced the first patient, a 59 year old Clearwater man, has been treated as part of the ATHENA clinical trial. The trial, sponsored by San Diego-based Cytori Therapeutics, derives stem cells from the patients own fat tissue and injects extracted cells into damaged parts of the heart. The ATHENA trial is a treatment for chronic heart failure due to coronary heart disease. Dr. Charles Lambert, Medical Director of Florida Hospital Pepin Heart Institute, is leading the way for the first U.S. FDA approved clinical trial using adipose-derived regenerative cells, known as ADRCs, in chronic heart failure patients. I am pleased to report that all procedures went well. The patient is doing well, he was released and is recovering at home. We look forward to following his progress over the coming months, said Dr. Charles Lambert. Heart failure (HF) can occur when the muscles of the heart become weakened and cannot pump blood sufficiently throughout the body. The injury is most often caused by inadequate blood flow to the heart resulting from chronic or acute cardiovascular disease, including heart attacks. The ATHENA clinical trial procedure … Continue reading →

Bernadette Tansey12/18/13 In the seven years since companies including Genentech/Roche and Regeneron launched new drugs to slow vision loss from an eye disorder called wet age-related macular degeneration, the market for those drugs has risen to an estimated $4 billion. But that substantial market may some day be dwarfed by the revenues flowing to companies with new treatments that can thwart the earlier and much more common form of macular degeneration, dubbed the dry form, which also erodes vision as it progressively damages a key eye structure called the macula. Not surprisingly, a pack of pharmaceutical giants and smaller biomedical companies are pursuing possible treatments for dry age-related macular degeneration (AMD), which afflicts an estimated 20 million to 30 million people worldwide. Competitors are testing different drug types, including antibodies and small molecules, and are targeting various biological mechanisms suspected as factors in the eye disorder. Taking another tack, companies such as Newark, CA-based Stem Cells, Inc. (NASDAQ: STEM) are injecting preparations of live cells into the eyes of clinical trial participants with the dry version of the disorder. The hope is that these stem cells will incorporate themselves into the eye structure, and take on the work of a … Continue reading →

December 17, 2013 by Arezu Sarvestani Florida regenerative therapies company Bioheart prepares to begin enrollment in a clinical study to evaluate stem cell treatment for patients with dry macular degeneration. Regenerative therapies company Bioheart (OTC:BHRT)is about to embark on a clinical trial to evaluate its proprietary stem cell therapy in treatment of dry macular degeneration, a condition which results in loss of vision. Bioheart will enroll up to 100 patients for treatment with its AdipoCell therapy, based on adipose derived stem cells. The trial won approval the Institutional Review Board of the International Cellular Medicine Society, Bioheart announced today. "Macular degeneration is a debilitating medical condition which results in the loss of vision and there are very few options for patients," principal investigator and Hollywood Eye Institute physician Dr. Shareen Greenbaum said on behalf of the company. "We are excited to determine whether cellular therapy can offer new hope to this patient population." Bioheart is developing its stem cell therapies for a range of conditions, including congestive heart failure, lower limb ischemia, chronic heart ischemia and others. The company earlier this year asked the FDA to approve "compassionate use" access for its MyoCell and LipiCell cell therapy products in at-risk … Continue reading →