But its always been clear that they could be risky too, especially if theyre not used carefully. The LCSB team has published its results in the scientific journal PLOS Biology.

This study shows that for the first time, targeting the proliferating tumor mass and dormant cancer stem cells with combination therapy effectively inhibited tumor growth and prevented metastasis compared to monotherapy in mice, said Wang, who is a member of the UCLA Jonsson Comprehensive Cancer Center and of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA. However, as of April 2016, new rules on human cells and tissue require FDA oversight and approval for such procedures.

Although the women had moderate vision loss prior to the stem cell treatments, a year later their vision ranged from total blindness to 20/200, which is considered legally blind.

NPR contacted the FDA, and was told by a spokeswoman that the agency is now finalizing a series of new guidelines regulating how clinics could use stem cells for treatment purposes. So far, however, scientists only partially understand how the body controls the fate of these all-rounders, and what factors decide whether a stem cell will differentiate, for example, into a blood, liver or nerve cell. He wrote an editorial accompanying the two papers.

As reported Wednesday in the New England Journal of Medicine, one of the women, a 72-year-old, went completely blind after doctors injected stem cells into her eye in an attempt to cure the disease.

But within a week of starting the off-the-charts dangerous therapy at an American clinic, the patients suffered complications.

Two of the patients sought treatment at the universitys hospital for the complications they suffered. The agency also noted that it had previously issued a warning to patients. She said that they were treating patients with their own stem cells.

In addition to charging a fee for treatment, there were several other red flags in the Florida cases that consumers should watch for when considering participation in a clinical trial, Goldberg said. They sought treatment at a Florida clinic that had announced a study to treat the condition on clinicaltrials.gov, a federal database of research studies.

Within days of the stem cell injections she was almost blind and ultimately progressed to complete blindness. Their attorney, Andrew Yaffa of Coral Gables, said that the case was resolved to the mutual satisfaction of the parties but that neither he nor his clients could comment beyond that.

She acknowledged, however, that the clinic had been performing the stem cell procedures.

Shoddy preparation of the stem cells may have led to some of the complications, said the study authors. We feel very confident about the procedures that we do, and weve had great success in many different indications. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases ultimately, we contend, lessening patient burdens, as well as reducing the associated economic impact disease imposes upon modern society.

The body produces a variety of stem cells. It is also costly, at almost $900,000 to develop and test the iPS cells for the first trial, Takahashi adds.

Whatever happened, experts said there was no evidence to suggest the procedure would have helped restore vision, since so little study has been done on whether adipose-derived stem cells can mature into the kinds of retinal cells that are involved in macular degeneration.

This represents a landmark, says Daley. But it proved too slow and expensive, says Shinya Yamanaka of Kyoto University in Japan, who first discovered how to create iPS cells and is a co-author of the NEJM paper. The registry may be useful as a starting point, but patients should then discuss potential trials with qualified physicians, an academic medical center.

A second patient was supposed to be treated, but transplantation was called off after the cells were found to have potential genetic problems. The cells were extracted their from fat, mixed with blood plasma and injected into their eyes.

Even though the safety and effectiveness of this procedure is unknown, all three patients received injections in both eyes. Dr. Thomas Albini of the University of Miami examined the women after they were treated at a clinic in Florida.

Before the procedure, all three women still had at least some vision. Medical experts said the episode raises questions about whether the government and doctors are doing enough to protect patients from the dangers of unapproved therapies.

See the rest here:
Three women blinded after clinical trial went wrong - Normangee Star

Comments are closed.