Advanced Cell Technology Starts Human Trials of Embryonic Stem Cells Under Strict FDA Supervision

7/20/11Follow @arleneweintraub

On July 14, Advanced Cell Technology (ACT)—a long-struggling developer of therapies derived from human embryonic stem cells—started its first human trials, by treating two patients suffering from blinding eye diseases. The company’s chief scientific officer, Robert Lanza, was still on a high when reached by phone in his Marlborough, MA, office a few days later. “It’s vindication,” he says. “In the early days, we were called murderers. We almost went under a few times. This was not easy.”

That may be an understatement. Ever since human embryonic stem cells were first isolated 13 years ago, ACT (OTCBB: ACTC) has been laboring to capitalize on the cells’ talent for transforming themselves into any tissue in the body. Over the years, Lanza and his colleagues have been blamed for everything from overconfidence to unethical science—the latter coming from conservative politicians who wanted to ban such research because the cells are derived from unborn embryos. But ACT charged ahead, raising money from hedge funds and other risk-hungry investors, and concentrating on using embryonic stem cells to regenerate retinal pigment epithelial (RPE) cells, which form a tissue that protects the eye’s photoreceptors.

ACT was cleared by the FDA to test its RPE cells in two separate trials: one in patients suffering from Stargardt’s macular dystrophy and the other in those with dry age-related macular degeneration (AMD). Stargardt’s affects young people, and AMD strikes the elderly, but they are both marked by the degeneration of the RPE cell layer. And both are leading causes of blindness. ACT was the second company cleared by the FDA to test an embryonic stem cell-derived therapy, the first being Geron (NASDAQ: GERN), the Menlo Park, CA-based company that’s testing its cells in patients with spinal cord injuries.

ACT’s first two patients were treated at the David Geffen School of Medicine at UCLA, and are now being watched for six weeks to ensure the cells don’t cause any dangerous side effects. Lanza explains that each trial will include 12 patients, and the doses will escalate over time. If no adverse events are observed in the first set of patients—who will receive the smallest dose of 50,000 RPE cells—the next set of patients will receive 100,000 cells. Then they’ll be observed, and so on, until the highest dose of 200,000 cells is reached.

Lanza says he was both intimidated and impressed by the FDA’s thorough review of ACT’s trial regimen. “They know as much as I do about embryonic stem cells,” he says. “They put us through … Next Page »

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  • William Connor

    I have dry ARMD and am losing my vision. I would be eager to participate in further trials.

  • Eugenia Ortiz

    I have wet macular degeneration in my right eye and would jump at the chance to be included in this trial.
    Please respond to me.

  • GUARINO GIUSEPPINA

    HO UNA RETINITE MIOPICA,E’ POSSIBILE ACCEDERE ALLA SPERIMENTAZIONE.GLI ESAMI CHE RICHIEDETE POSSO FARLI A PALERMO O LI DEVO FARE FARE IN OSPEDALE DA VOI?
    ATTENDO NOTIZIE,CORDIALI SALUTI
    GUARINO GIUSEPPINA

  • Kathleen Harnden

    I’ve had myopic degeneration since 35 years old.I am now 63. Right eye considered blind. Left eye now having problems. I am more than willing to particapate in trials. Live in Spring Hill, Florida but will travel.
    Please reply.

    Thanks