Category Archives: Stem Cell Human Trials

In the mid 1990s, the Michigan CardioVascular Institute Research Department at Covenant HealthCare was formed. This department facilitates the last step of clinical trials before medical advances are available to the public. Recently, the department has been busy with the Stem Cell & Regenerative Medicine Program, enrolling the first patients in the nation and first patient in the state for two clinical trials. Kerwood Woody Crutchfield of Caro, is one of those patients. Suffering from eight heart attacks over the years, Kerwood was diagnosed with congestive heart failure, a disorder that occurs when the heart is unable to pump sufficient blood flow through the body. About 10 years ago we heard about these clinical trials, Crutchfield said. I have been looking into studies like this for several years. I had originally enrolled in another study, but it was a restrictive program and I tested out. After that, Crutchfield was contacted as a candidate for the STOP-HF Trial with the Saginaw-based research department. Considerable scientific evidence has emerged over the past decade demonstrating the high therapeutic potential of stem cell-based regenerative medicine for a host of diseases, officials stated. Stem cells are the building blocks for every organ, tissue and cell … Continue reading →

NEWARK, Calif., Sept. 12, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced dosing of the first high-dose patient in the Company's Phase I/II clinical trial in dry age-related macular degeneration (AMD). The patient, the fifth overall in the 16-patient trial, was transplanted yesterday with one million HuCNS-SC(R) cells (purified human neural stem cells). The first four patients each received a dose of 200,000 cells. An independent Data Safety Monitoring Committee conducted a review of the trial data to date, and found no safety issues to preclude the trial from proceeding to the high dose. "Advancing to the high dose, which is a five-fold increase from the low dose, is an important milestone in this trial," said Stephen Huhn, MD, FACS, FAAP, Vice President, CNS Clinical Research at StemCells. "Testing a cell dose of this magnitude in all the remaining patients planned for the trial will enhance our ability to assess the effect of the cells on visual acuity. "Also, we are pleased to announce that we have received permission from the FDA to open three more U.S. trial sites in addition to the Retina Foundation of the Southwest and the Byers Eye Institute at Stanford, the two currently active … Continue reading →

However, Dr Manuel Serrano, who led the research which is published in the journal Nature, said it would be at least five years before the first clinical trials to reprogram adult cells in human patients. He said: The main surprise of our work is that it is possible to generate pluripotent stem cells directly in the tissue in living organisms. We can imagine that transitory reprogramming could help in the natural regeneration of damaged tissue. In principal we hope that it could help to repair any kind of damage like in the heart, brain or liver, but we have still to find which will respond best. The research, which is published in the journal Nature, used genetically modified mice that carried a gene cassette that caused them to produce the reprogramming factors. They were given a drug in their drinking water that turned the genes on and caused the reprogramming factors to be released, leading to the development of induced pluripotent stem cells that were similar to the stem cells found in the early stages of a developing embryo. These have the capacity to develop into almost any other tissue found in the body, although the scientists have still to … Continue reading →

NEWARK, Calif., Sept. 9, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced the publication of a comprehensive overview describing the therapeutic potential and results from early clinical trials of the Company's proprietary HuCNS-SC(R) product candidate (purified human neural stem cells). The paper was published recently in Stem Cell Research & Therapy, an international peer-reviewed journal considered to be the major forum for translational research into stem cell therapies, and is part of a series about clinical applications of stem cells edited by Mahendra Rao, MD, PhD, Director, NIH Center for Regenerative Medicine. "This review lays out the rationale and clinical translation strategy underlying our HuCNS-SC programs in central nervous system disorders," said Ann Tsukamoto, PhD, Executive Vice President, Scientific and Strategic Alliances at StemCells and lead author on the paper. "As a company, we have gone the extra mile to identify, prospectively purify and extensively characterize the biological activity of our neural stem cells, which has produced robust and reproducible results in a number of disease models. Our human neural stem cells are being developed for disorders of the brain, the spinal cord and the eye, so our results have been published in a number of respected journals specific … Continue reading →

San Diego, CA (PRWEB) September 03, 2013 Histogen, Inc., a regenerative medicine company developing innovative therapies for conditions including hair loss and cancer, today announced that the United States Patent & Trademark Office has issued patent 8,524,494, entitled Low Oxygen Tension and bFGF Generates a Multipotent Stem Cell from a Fibroblast In Vitro to the Company. The issued patent covers Histogens method of triggering the de-differentiation of fibroblast cells into multipotent stem cells through low oxygen and special culture conditions. The resulting multipotent cells naturally secrete a variety of soluble and insoluble molecules that are the basis for Histogens products. Histogens process is uniquely capable of harnessing all of the benefits and excitement of stem cell therapies without any of the ethical, safety or sourcing concerns, said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. Issuance of this patent adds great strength to our technology, and value to our partners and products. Current stem cell-derived therapies utilize embryonic stem cells or genetically-manipulated induced pluripotent stem cells, both of which have an inherent ethical and scientific risk, and raise a number of regulatory issues. Still, enthusiasm continues to build around stem cells, both for their potential to address … Continue reading →

Newswise Four prominent researchers from UCLAs Eli & Edythe Broad Center of Regenerative Medicine and Stem Cell Research have received Early Translational research awards totaling approximately $13 million from the California Institute for Regenerative Medicine (CIRM) the state stem cell agency. The UCLA researchers received four of the 12 total awards; no other applicant institution received more than one award. Dr. Jerome Zack professor of medicine and microbiology, immunology and molecular genetics; Dr. Robert Reiter, Bing professor of urologic research; Dr. Donald Kohn professor of pediatrics and microbiology, immunology and molecular genetics in the life sciences; and Dr. Gerald Lipshutz, associate professor-in-residence of surgery, urology and medicine each received grants that were announced at the meeting of the Independent Citizens Oversight Committee, CIRMs governing body, in La Jolla, CA on August 28, 2013. The grants are part of CIRMs Early Translational Research Initiative, which aims to fund and advance promising, innovative discoveries using stem cells. In this early translation phase, scientists are expected to do research that will result in the development of drugs or cellular therapies to be used in FDA-approved clinical trials; translating discoveries from the laboratory to the clinic as quickly as possible. Our CIRM grants highlight … Continue reading →

LAST week, I did an introduction on the use of and how stem cells can be beneficial in the treatment of illnesses, and how, this breakthrough in medical science should be handled with caution as well. It is good to bear in mind that, one treatment modality may be good for one patient, and may not be so for another patient. It is not uncommon for patients to feel well after a given treatment: one?s mind set and positive outlook and optimism can do wonders in one?s response to a given treatment. It may also be that at that time when the patient claimed to have felt better, that the natural fluctuations of the disease itself may be in occurrence; thus, the caution on the use of testimonials as a means of promoting something as a tool to advertise. Stem cell therapy, just like other discoveries in medicine and science, takes years to become perfected, for it to become ready for actual use in human beings. Research and studies and clinical trials don?t produce results overnight. As a general rule, the process involved is long and tedious, and requires animal models before it is administered to humans. The sad fact … Continue reading →

Worcester, MA (PRWEB) August 28, 2013 The National Institutes of Health (NIH) has awarded a five-year, $1.94 million grant to a biomedical research team at Worcester Polytechnic Institute (WPI) working at the forefront of cell therapies for healing cardiac muscle damaged by heart attack or chronic disease. Funded through the NIH's premiere Research Project Grant (R01) program, the project will be led by Glenn Gaudette, PhD, associate professor of biomedical engineering at WPI, working in close collaboration with George Pins, PhD, associate professor of biomedical engineering at WPI, and Michael Laflamme, MD, PhD, associate professor of pathology at the University of Washington. "We are grateful for the support of the National Institutes of Health and we hope that this intensive program of research will advance cell therapies for people who suffer from heart disease," Gaudette said. The multifaceted research program funded by the NIH grant is based on the use of biopolymer microthreads to deliver adult stem cells into damaged hearts to promote muscle regeneration. The microthreads, each about the width of a human hair, can be braided into cable-like structures that mimic natural connective tissues. First developed in Pins's lab as a potential tool for repairing torn anterior cruciate … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX) today announced that it has received approval from The Spanish Agency of Medicines and Medical Devices (AEMPS) to begin human clinical trials of Renevia, a unique biomaterial used as a delivery matrix for autologous adipose derived cells to treat the loss of subcutaneous adipose tissue (lipoatrophies) arising from trauma, surgical resection, and congenital defects and disease. This AEMPS approval follows the earlier approval this year from the Balearic Island Ethics Committee Approval for the first of a multiphase clinical investigation of Renevia. The clinical studies will be conducted at The Stem Center in Palma de Mallorca, Spain, an innovative patient therapy center, laboratory, and professional research facility located within the Clinica USP Palma Planas hospital in Palma. The Medical Director of The Stem Center and Principal Investigator for the Renevia studies, Ramon Lull, MD, PhD, is a leading expert on advanced regenerative therapies based on adipose technology. The Stem Center is owned and operated by the GID Group, Inc., Louisville, CO, USA. BioTime expects that the first clinical investigation, a study in 10 volunteers to demonstrate the safety of Renevia in humans, will be completed before the end of the year. Subsequent … Continue reading →

Manila, Philippines -- The Food and Drug Administration (FDA) said the government will not regulate the prices and fees for stem cell therapies in the country as the discussion about the new and contentious form of treatment continues to heat up in the Philippine medical community. ''We don't regulate price and we will probably never do that,'' said Dr. Kenneth Hartigan-Go, FDA director, at a recent public hearing in Alabang, Muntinlupa, conducted by the FDA and Department of Health (DOH) on stem cell therapy regulation. Earlier this month, 22 medical professional organizations in the country including the Philippine College of Physicians, Philippine College of Surgeons and Philippine College of Chest Physicians issued a declaration that denounced false claims, misinformation and exorbitant fees imposed for unproven stem cell treatments in the country. At the public hearing, Go and Dr. Cynthia Rosuman of the DOH's Bureau of Health Facilities and Services (BHFS) discussed the DOH's Administrative Order 2013-0012, which set the rules and regulations governing accreditation of health facilities engaging in human stem cell, cell and cell-based therapies in the country. The FDA's regulations on stem cell products and facilities were also discussed at the forum attended mostly by medical professionals. Stem … Continue reading →