Monday, March 15, 2010
Sunday, March 07, 2010
Stargardt's Macular Dystrophy and Stem Cell Treatment
Advanced Cell Technology‘s RPE Cells Granted Orphan Drug Status from FDA for Treatment of Stargardt’s Macular Dystrophy
First-Ever Designation for Treatment Using Embryonic Stem Cells
WORCESTER—Advanced Cell Technology, Inc. (OTCBB: ACTC – News), a biotechnology company applying cellular technology in the field of regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company’s MA09-hRPE cells for use in the treatment of Stargardt’s Macular Dystrophy (SMD). As a result, the company is eligible to receive a number of benefits, including tax credits, access to grant funding for clinical trials, accelerated FDA approval and allowance for marketing exclusivity after drug approval for a period of as long as seven years.
“We are pleased that the FDA has, for the first time, granted orphan drug status for the use of an embryonic stem cell derived therapy in treating an unmet medical need,” said Edmund Mickunas, Vice President Regulatory. “We believe that our terminally differentiated RPE cells represent a promising treatment for patients with SMD and expect to be in a position to accelerate clinical development and hopefully make RPE cellular therapy available to the majority of patients sooner.”
US orphan drug designation is granted to companies with products aimed at treatment of a rare disease or condition that affects fewer than 200,000 Americans. The National Institutes of Health (NIH) recently proposed broadening the definition of a human embryonic stem cell to include ACT’s “single blastomere technology platform” which was used to derive ACT’s MA09-hRPE cells. The Company believes that the SMD program should be eligible for federal funding once the change is published in the Federal Register.
Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world, and as many as ten million people in the United States have photoreceptor degenerative disease. While most of these patients have Age-Related Macular Degeneration (AMD), a smaller number have Stargardt’s, an Orphan disease and to date an untreatable form of juvenile macular degeneration leading to blindness in a much younger group of patients than are affected by AMD. ACT’s treatment for eye disease uses stem cells to re-create a type of cell in the retina that supports the photoreceptors needed for vision. These cells, called retinal pigment epithelium (RPE), are often the first to die off in SMD and AMD, which in turn leads to loss of vision.
While there is currently no treatment for SMD, several years ago ACT and its collaborators discovered that human embryonic stem cells could be a source of RPE cells. Subsequent studies found that the cells could restore vision in animal models of macular degeneration. In a Royal College of Surgeons (RCS) rat model, implantation of RPE cells resulted in 100% improvement in visual performance over untreated controls, without any adverse effects. The cells survived for more than 220 days and sustained extensive photoreceptor rescue. Functional rescue was also achieved in the ‘Stargardt’s’ mouse with near-normal functional measurements recorded at more than 70 days.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.
Wednesday, February 10, 2010
Thursday, February 04, 2010
Photoreceptors generated from adult human skin cells
Crafting Light-Sensing Cells from Human Skin
http://www.technologyreview.com/biomedicine/24457/
Monday, January 11, 2010
Monday, January 04, 2010
Pet tarantulas pose risk to owners' eyes, say doctors
BBC News - Pet tarantulas pose risk to owners' eyes, say doctors
Sunday, November 15, 2009
Dr. Edward Kondrot, Homeopathic Ophthalmologist: Pittsburgh Seminar - December 6. Three Day Treatment Program - December 7 - 9
Dr. Kondrot will be returning to Pittsburgh from December 6 - 9, 2009 and will hold a 1 day informational seminar on Sunday, December 6, followed by a 3 day treatment program beginning Monday, December 7.
During the seminar, a wide range of ocular conditions will be discussed along with alternative and homeopathic treatment strategies. Learn how vision threatening conditions such as Macular Degeneration, Glaucoma, and Diabetic Retinopathy can often be successfully treated and managed incorporating Dr. Kondrot's unique non-invasive holistic therapies.
More about Dr. Kondrot:
- Has practiced ophthalmology for over 18 years and classical homeopathy for 10 years
- Received his MD in 1977 from Hahnemann Medical College in Philadelphia, Pennsylvania
- Completed his residency in Ophthalmology at the Scheie Eye Institute in Philadelphia, Pennsylvania and at St. Francis General Hospital in Pittsburgh, Pennsylvania, becoming a board certified Ophthalmologist in 1981
- Received his diploma from the Hahnemann Homeopathic College in Albany, California in 1995
- Became certified by the Council of Homeopathic Certification in 2000
- Became Doctor of Homeopathic therapeutics (DHt) in 2002
- Dr. Kondrot has an active medical license in Arizona and Pennsylvania
You may also contact me directly either by email or phone. I will promptly reply to all inquiries.
I will be joining Dr. Kondrot for his Sunday seminar and I look forward to seeing many of you there!
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