Posted on February 25, 2008 by jrowley
Q Therapeutics, a cell therapy company focusing on neural applications, recently announced a $15M series B financing that included funding from multiple venture capital (VC) groups as well as biotech tools provider Invitrogen. Q’s lead product, Q-Cells™, is an allogeneic product intended to restore function to damaged neurons by providing trophic (e.g. cytokines, growth [...]
Filed under: Bioprocessing, Clinical Trials, Company Profiles, MS, Manufacturing, Neural Repair, Q Therapeutics, Regenerative Medicine, adult stem cell, stem cells | Tagged: symbiotic business relationships, cell therapy tools, cell therapy development, GMP-grade kits and reagents | 2 Comments »
Posted on February 14, 2008 by jrowley
ES cell biopsy from blastocyst.
Filed under: Advanced Cell Technology, Athersys, Clinical Trials, Cytori, Embyonic Stem Cells, FDA, Geron, JNJ, Novocell, Osiris, Regenerative Medicine, adult stem cell, spinal cord injury, stem cells | Tagged: Clinical Trials, embryonic vs adult stem cell, embyryonic stem cell 2008, evolving clinical landscape, safety issues | No Comments »
Posted on February 1, 2008 by jrowley
Cytori Therapeutics announced that they have enrolled their first two patients in an acute myocardial infarction clinical trial using adipose-derived cells prepared using their Celution™ device. The Celution™ device is an automated, tissue processing unit that isolates cells from adipose tissue derived via liposuction.
Filed under: Bioprocessing, Clinical Trials, Company Profiles, Cytori, Device-centric cell therapies, Regenerative Medicine, adult stem cell, autologous, cardiac regeneration, cell delivery, patient specific cell therapy, personalized medicine, stem cells | No Comments »
Posted on January 29, 2008 by jrowley
You have to hand it to Tengion, they are trying to tackle one of the largest challenges I can think of: producing tissue engineered organs and tissues from a patients own cells in unrelated indications (bladder, blood vessel, and kidney). While moving through clinical trials Tengion will surely be transforming patients lives with these [...]
Filed under: Biomaterials, Bioprocessing, Clinical Trials, Company Profiles, JNJ, Regenerative Medicine, Tengion, autologous, combination products, patient specific cell therapy, personalized medicine, tissue engineered product, vascular regeneration | Tagged: autologous therapies, company prifile, tissue engineering company | 3 Comments »
Posted on January 22, 2008 by jrowley
Pervasis Therapeutics announced that they have raised $9.75M to further develop their allogenic tissue engineered endothelial cell (EC) product for vascular health indications. Their Vascugel product is comprised of ECs grown in 3D collagen sponges that are implanted externally on blood vessels to prevent them from occluding. Pervasis has proven safety in a Phase I [...]
Filed under: Biomaterials, Bioprocessing, Clinical Trials, Company Profiles, Manufacturing, Pervasis, Regenerative Medicine, cell delivery, combination products, tissue engineered product, vascular regeneration | Tagged: end stage renal disease, endothelial cells, ESRD, gelfoam, tissue engineering, vascular health | No Comments »
Posted on January 12, 2008 by jrowley
Osiris Therapeutics announced that they won a DoD contract worth up to $224.7 million for developing their adult mesenchymal stem cell (MSC)-based therapeutic for treating acute radiation exposure. The contract allows for reimbursement of up to $24.7 million for continued development of their Prochymal product, and then, once the product is FDA approved for [...]
Filed under: Clinical Trials, DoD, MSCs, Osiris, Regenerative Medicine, adult stem cell, business models, stem cells | Tagged: Acute Radiation Therapy, DoD contract, Mesenchymal Stem Cell product, near term revenue, Prochymal, Type 1 diabetes | No Comments »
Posted on December 31, 2007 by jrowley
The FDA has scheduled an April 10, 2008 meeting to “discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells.” This meeting will be followed by another meeting on April 11 that will “discuss updates on 1) research management related to the September 29, 2005 review of research programs [...]
Filed under: Advanced Cell Technology, Clinical Trials, Embyonic Stem Cells, FDA, Geron, Novocell, Regenerative Medicine, cell delivery, regulatory, stem cells | 1 Comment »
Posted on December 23, 2007 by jrowley
Athersys and their cardiac parter, Angiotech, announced today that they got the ok from the FDA to begin a Phase I clinical study using Athersys’ Multistem adult stem cell product in acute myocardial infarction (MI). This is the second IND approval for Athersys in just over a month (and a welcome Christmas present for [...]
Filed under: Angiotech, Athersys, Biomaterials, Clinical Trials, Joint Ventures, Regenerative Medicine, cardiac regeneration, cell delivery | Tagged: Angiotech, Athersys, cardiac cell therapy, cell delivery, IND | No Comments »
Posted on December 1, 2007 by jrowley
Osiris Therapeutics last week announced positive data that came out of their Phase I/II double blinded Chondrogen trial. They demonstrated statistically significant improvements in joint pain in patients with osteoarthritis, however this seems to be an about face compared to when they announced their “disappointing” (the CEO’s words) interim 6 [...]
Filed under: Biomaterials, Clinical Trials, Osiris, Regenerative Medicine, adult stem cell, cartilage, orthopedics, stem cells | 1 Comment »
Posted on November 26, 2007 by jrowley
CellCyte Genetics Corporation recently announced that US Patent No 7,282,222 was issued, a patent which they have exclusive rights to. The press release states that the patent covers unique methods and compositions “to deliver and direct stem cells to target organs in the body”, including cardiac tissue.
The focus of the patent addresses cell retention at [...]
Filed under: Clinical Trials, Intellectual Property, Regenerative Medicine, cardiac regeneration, cell delivery, stem cells | 1 Comment »
Posted on November 20, 2007 by jrowley
On November 15, 2007, Athersys announced in a press release that they had received a letter from the FDA giving the green light to start a Phase I safety study of MultiStem, their adult, allogeneic stem cell product. Athersys will start an open label, dose escalation trial to test their cells after bone marrow transplantation.
This [...]
Filed under: Athersys, Clinical Trials, FDA, MSCs, Osiris, Regenerative Medicine, adult stem cell, stem cells | Tagged: adult stem cells, Athersys, business model, stem cells clinical trials | 1 Comment »
Posted on November 20, 2007 by jrowley
An interesting study was published this week in the Journal of Neuroimmunology spurring a press release from Geron that stated “GERON’S HUMAN EMBRYONIC STEM (ES) CELL-BASED THERAPEUTIC FOR SPINAL CORD INJURY EVADES DIRECT ATTACK BY THE HUMAN IMMUNE SYSTEM”. The title is a little misleading since the cells really only evade immune cells in an [...]
Filed under: Advanced Cell Technology, Clinical Trials, Embyonic Stem Cells, Geron, Regenerative Medicine, regulatory, spinal cord injury, stem cells | Tagged: Clinical Trials, embryonic stem cells, immune response, spinal cord injury | No Comments »
