Tag Archives: FDA

Excellagen used in Stem Cells human clinical study

Taxus Cardium Pharmaceuticals Group Inc announced that the Company’s Excellagen flowable dermal matrix in combination with Orbsen Therapeutics’ mesenchymal stromal stem cell therapy Cyndacel-M has been selected for clinical evaluation in a Phase 1b safety study for the potential treaent of chronic diabetic wounds to be funded by the European Union under EU Framework 7.

The project, known by the acronym “REDDSTAR” (Repair of Diabetic Damage by Stromal Cell Administration), is being coordinated by Professor Timothy O’Brien, Dean of Medicine and Director of Ireland’s Regenerative Medicine Institute at National University of Ireland Galway.

In the initial phase of the project, academic
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Adult Stem Cell Research Shows Promise

Scientists sporting white coats and safety gloves are working in a bright Food and Drug Administration (FDA) lab on an incredible project.

They are part of FDA’s MSC Consortium, a large team of FDA scientists studying adult mesenchymal stem cells (MSCs)—cells that could eventually be used to repair, replace, restore or regenerate cells in the body, including those needed for heart and bone repair.

The scientists’ investigational work is unprecedented: Seven labs at FDA’s Center for Biologics Evaluation and Research formed the consortium to fill in gaps in knowledge about how stem cells function (…)

Legal expert explores risks, rewards of using stem cell products

The brave new world of stem cell research dangles the exciting potential for a host of leading-edge treatments that may one day help cure debilitating diseases such as Alzheimer’s, Parkinson’s and other maladies that today cannot be treated with modern medicine.

However, not much thought has been given to how those products might be regulated and how issues of legal liability may be addressed in a way that encourages scientific innovation but also protects the patients for whom these treatments might provide great relief.

Now, an attorney and law professor from the UCLA School of Law and a member of the
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Stem Cells To Help Treat Brain Injury and Hearing Loss

Cord Blood Registry (CBR) is the exclusive partner for a growing number of clinical researchers focusing on the use of a child’s own cord blood stem cells to help treat pediatric brain injury and acquired hearing loss. To ensure consistency in cord blood stem cell processing, storage and release for infusion, three separate trials have included CBR in their FDA-authorized protocol—including two at the University of Texas Health Science Center at Houston (UTHealth) working in partnership with Children’s Memorial Hermann Hospital, and a third at Georgia Health Sciences University, home of the Medical College of Georgia (MCG). This makes
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US Patients Battle the FDA Over Use of Their Own Cells

American Doctors and Patients Challenge the FDA to Save Lives Rather Than Allow Patients to Needlessly Die
A couple of weeks ago, the American Stem Cell Therapy Association (ASCTA) was formed by a group of doctors, not to debate the pros and cons of embryonic stem cell research and adult stem cell research, but to […]