Category Archives: Clinical Trials

Q Therapeutics’ and Invitrogen’s Symbiotic Relationship

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 … Continue reading →

Posted in adult stem cell, Bioprocessing, Clinical Trials, Company Profiles, Manufacturing, MS, Neural Repair, Q Therapeutics, Regenerative Medicine, stem cells | Tagged , , , | 2 Comments

The Developing Embyronic Stem Cell Clinical Landscape

Posted on February 14, 2008 by jrowley

ES cell biopsy from blastocyst. Continue reading →

Posted in adult stem cell, Advanced Cell Technology, Athersys, Clinical Trials, Cytori, Embyonic Stem Cells, FDA, Geron, JNJ, Novocell, Osiris, Regenerative Medicine, spinal cord injury, stem cells | Tagged , , , , | Leave a comment

Cytori Announces Progress in Cardiac Regeneration Clinical Studies

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 … Continue reading →

Posted in adult stem cell, autologous, Bioprocessing, cardiac regeneration, cell delivery, Clinical Trials, Company Profiles, Cytori, Device-centric cell therapies, patient specific cell therapy, personalized medicine, Regenerative Medicine, stem cells | Leave a comment

Tengion Pioneers Autologous Tissue Engineered Regenerative Medicine Products

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). … Continue reading →

Posted in autologous, Biomaterials, Bioprocessing, Clinical Trials, combination products, Company Profiles, JNJ, patient specific cell therapy, personalized medicine, Regenerative Medicine, Tengion, tissue engineered product, vascular regeneration | Tagged , , | 3 Comments

Pervasis Advances Tissue Engineered Products for Vascular Health

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 … Continue reading →

Posted in Biomaterials, Bioprocessing, cell delivery, Clinical Trials, combination products, Company Profiles, Manufacturing, Pervasis, Regenerative Medicine, tissue engineered product, vascular regeneration | Tagged , , , , , | 1 Comment

Osiris Scores $225M DoD Contract for Acute Radiation Syndrome Treatment with Prochymal Adult Stem Cell Product

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 … Continue reading →

Posted in adult stem cell, business models, Clinical Trials, DoD, MSCs, Osiris, Regenerative Medicine, stem cells | Tagged , , , , , | 1 Comment

FDA Proactively Addresses Embryonic Stem Cell Safety Testing

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 … Continue reading →

Posted in Advanced Cell Technology, cell delivery, Clinical Trials, Embyonic Stem Cells, FDA, Geron, Novocell, Regenerative Medicine, regulatory, stem cells | 1 Comment

Athersys’ Adult Stem Cell Product IND Approved for Acute MI Phase I Trial

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 … Continue reading →

Posted in Angiotech, Athersys, Biomaterials, cardiac regeneration, cell delivery, Clinical Trials, Joint Ventures, Regenerative Medicine | Tagged , , , , | Leave a comment

Osiris Releases 1 Year Data from Chrondrogen Trial

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 … Continue reading →

Posted in adult stem cell, Biomaterials, cartilage, Clinical Trials, orthopedics, Osiris, Regenerative Medicine, stem cells | 1 Comment

CellCyte Issued Patent for Enhancing Cell Delivery to Cardiac Tissue

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 … Continue reading →

Posted in cardiac regeneration, cell delivery, Clinical Trials, Intellectual Property, Regenerative Medicine, stem cells | 1 Comment

Athersys’ adult allogeneic stem cell IND gets OK from FDA

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 … Continue reading →

Posted in adult stem cell, Athersys, Clinical Trials, FDA, MSCs, Osiris, Regenerative Medicine, stem cells | Tagged , , , | 1 Comment

Geron publishes data suggesting that Embyonic Stem Cells may not need long term immunosuppression

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 … Continue reading →

Posted in Advanced Cell Technology, Clinical Trials, Embyonic Stem Cells, Geron, Regenerative Medicine, regulatory, spinal cord injury, stem cells | Tagged , , , | Leave a comment