Advanced Cell Technology Betting Future on Embryonic Stem Cell Therapy for Eye Disease

12/16/09

Advanced Cell Technology is banking on an experimental cellular therapy for a rare eye disease to show the world that controversial embryonic stem cells have a place in treating diseases. Amid serious financial constraints at the Worcester, MA-based biotech firm (OTCBBACTC), a plan is in place to pioneer the use of cellular therapies made with human embryonic stem cells as treatments for people.

The biotech last month asked the FDA for permission to conduct a Phase I/II clinical trial of its stem cell therapy for Stargardt’s Macular Dystrophy, a genetic disease that is a leading cause of blindness in children. Bill Caldwell, the company’s chairman and CEO, told me this week that the experimental Stargardt’s treatment is the firm’s top priority and its best chance to prove that embryonic stem cells can make effective treatments for diseases.

The company and the field of human embryonic stem cells both need a big win. Advanced Cell Technology (ACT) has operated for 15 years without a commercial success, and the firm has been forced to nearly halve its operations since last year to stay afloat. Research on human embryonic stem cells has been mired in controversy and political attacks over fears about destroying human embryos to harvest stem cells—even though ACT and other firms have found ways to produce stem cells without harming embryos. And companies like ACT have been slow to move embryonic stem cell therapies into human clinical trials, despite the promise of such cells to provide the building blocks for regenerating tissues to repair organs damaged by serious conditions like heart disease, macular degeneration, and spinal cord injuries.

“This industry is in need of successes,” said Caldwell. “The technology of embryonic stem cells is very powerful and it needs validation.”

ACT has the burden of trying to become one of the first companies to test human embryonic stem cells as a therapy in humans, meaning the FDA, which must okay the clinical trials, has lots of questions about their potential health effects. Caldwell said that his firm has been in discussions with the FDA about the its proposed clinical trial with Stargardt’s patients, and the he hopes to have addressed all the agency’s concerns in time to begin the pioneering study in the third quarter of 2010.

The FDA has only authorized one company to test the use of embryonic stem cell therapies in humans: Menlo Park, CA-based biotech Geron, which was forced delay the its first human study for treating victims of spinal chord injuries in August due to the FDA’s concens about data it received on the treatment after it granted permission to conduct the trial. Geron (NASDAQ:GERN) said in October that it’s conducting animal tests to show the FDA that … Next Page »

Single Page Currently on Page: 1 2 3

By posting a comment, you agree to our terms and conditions.

  • CHUCK McMULLEN

    I’M A 58 YEAR OLD MALE WITH STARGARTS AND HAVE BEEN LEGALLY BLIND SINCE THE AGE OF 16, ALL THESE TALKS ABOUT STEM CELL THERAPY IS GREAT NEWS CAUSE IT IS TOUGH BEING BLIND, BUT YET CAN SEE PEOPLE JUST DON’T BELIEVE YOU WHEN YOU TELL THEM

  • Michael Swit

    A minor correction. Advanced Cell is not “based” in Worcester, but is headquartered in Santa Monica, CA according to the firm’s website (see michael.swit@weinberggroup.com). Using the term “based” implies that is the HQ. Rather, the Worcester facility, with all due respect ot what occurs there, is described as the firm’s “Massachusetts Laboratory Facility.”

  • Michael Swit

    Correction to my correction. ACT’s website statement about where its HQ is located appears at http://www.advancedcell.com/contact-us/.

  • Ryan

    Michael, thank you for the comment. You bring up a good point: the website says the company’s headquarters are in Santa Monica. I was told that most of the firm’s employees are now in Massachusetts and that the Californa headquarters was shut down. I’ll look into this; the Santa Monica address is a PO Box, so there may be no office there. -Ryan

  • Greg Macgregor

    I’m a shareholder and this is good news, but how did this release pass with so many grammatical errors? It read’s like it was written by an 8 year old.

  • Dirty

    There are some reports of possibly starting trials as early as March 2010. So…are trials starting Q3 2010 or March 2010?

  • Greg Macgregor

    Dirty, matters little. If you want to invest then read this (although you probably have already):
    http://www.pinksheets.com/edgar/GetFilingHtml?FilingID=6902717

    March or October, that is still not the 1000% we wait on. This one will take some time but still pay off swimmingly.

  • Psfranko

    My child has Stargardt’s Disease. We are so hopeful for this type of treatment….It does seem in regards to animal trials that it works. I hope the company can stay afloat!

  • Alicia

    I have been waiting for this for years. I knew they would come up with something. I am 30 and have had it since I was 9, and bee legally blind since I was 18. I hope and pray I can be a part of this stdy it would be the best thig just to know if it can help me how many other diseases out there it will help.

  • feeed

    Yes Dr. Lanza will be the first Being to heal the Blind since Jesus.

    The Blind will see again, the lame will walk and people will not rott from cancer. Mark my feeed word Healing instead of treating is going to happen in the next 20years.

    feeed loves lanza

  • Eugenia Ortiz

    I have macular degeneration and would love to be helped.
    Please respond to me.