Safety results of intra-arterial stem cell clinical trial for stroke presented

ScienceDaily (Oct. 11, 2012) — Early results of a Phase II intra-arterial stem cell trial for ischemic stroke showed no adverse events associated with the first 10 patients, allowing investigators to expand the study to a targeted total of 100 patients.

The results were presented October 11 by Sean Savitz, M.D., professor of neurology and director of the Stroke Program at The University of Texas Health Science Center at Houston (UTHealth), at the 8th World Stroke Congress in Brasilia, Brazil.

The trial is the only randomized, double-blind, placebo-controlled intra-arterial clinical trial in the world for ischemic stroke. It is studying the safety and efficacy of a regenerative therapy developed by Aldagen Inc., a wholly-owned subsidiary of Cytomedix, Inc., that uses a patient's own bone marrow stem cells, which can be administered between 13 and 19 days post-stroke.

The therapy, called ALD-401, consists of stem cells that are identified using Aldagen's proprietary technology to isolate cells that express high levels of an enzyme that serves as a marker of stem cells. Pre-clinical studies found that these cells enhance recovery after stroke in mice. The cells are administered into the carotid artery. Patients are followed for 12 months to monitor safety and to assess mental and physical function.

"We have been approved by the Data Safety Monitoring Board (DSMB) to move the study into the next phase, which will allow us to expand the number of sites in order to complete enrollment," said Savitz, senior investigator for the multi-center study. As per the protocol for the trial, the Food and Drug Administration required a review by the DSMB prior to advancing to the next phase.

Preclinical research, including research at the UTHealth Medical School, has suggested that stem cells can promote the repair of the brain after an ischemic stroke, which is caused by a blood clot in the brain. Stroke is a leading cause of disability and the fourth-leading cause of death in the United States, according to 2008 statistics reported by the Centers for Disease Control and Prevention.

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The above story is reprinted from materials provided by University of Texas Health Science Center at Houston.

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Post-Op Radiation May Boost Results for Prostate Cancer Patients: Study

FRIDAY, Oct. 19 (HealthDay News) -- A new French study supports the use of radiation therapy after prostate cancer surgery to help prevent recurrence in high-risk patients.

Surgery to remove the prostate (radical prostatectomy) is one of the main treatments for prostate cancer. Experts, however, say the risk of recurrence can be 10 percent to 50 percent in patients whose cancer has already spread beyond the prostate, so post-surgery radiation therapy is commonly prescribed for these men.

The new study included more than 1,000 high-risk prostate cancer patients who had surgery and were followed for more than 10 years. Some of them had immediate radiation therapy (given within four months of surgery) while others were simply monitored for signs of cancer recurrence (watchful waiting).

After 10 years, 61 percent of men who received immediate radiation therapy remained cancer-free, compared with 38 percent of those in the watchful waiting group, according to the study, which was published online Oct. 18 in the journal The Lancet.

"These long-term results reassure us of the continued benefit and safety of radiation therapy after prostatectomy for a large proportion of men with locally advanced or high-risk prostate cancer," study leader Michel Bolla, a professor at the Centre Hospitalier Universitaire A Michallon, in France, said in a journal news release.

Bolla also noted that factors such as patient age or tumor status could play into decisions around whether to use radiotherapy. Younger patients, or those whose biopsy shows evidence of cancer's spread, may gain from post-surgical radiation treatments, whereas the therapy might cause more harm than benefit for patients aged 70 or older.

Two specialists in the field said the findings come as little surprise.

"This study confirms what radiation oncologists have known for many years -- namely that certain adverse risk factors seen on final [laboratory results] after a prostatectomy warrant immediate postoperative radiation," said Dr. Jonathan Haas, chief of radiation oncology at Winthrop University Hospital in Mineola, N.Y.

Dr. Louis Potters, chairman of radiation medicine at North Shore-LIJ Health System in New Hyde Park, N.Y., agreed.

"In certain men who have surgery for localized prostate cancer, post-operative radiation therapy is a powerful tool that can improve cancer outcomes," he said. Beyond offering certain patients "a second chance at a cure," post-op radiation treatment "also decreases the chances of needing future hormone therapy, which can have an array of unwanted side effects," Potters said.

But Haas stressed that teamwork is key to the proper care of any patient with prostate cancer.

"This study underscores the need for close interdisciplinary cooperation between the urologist, radiation oncologist and pathologist to come up with a tailored treatment plan to maximize outcome for a given patient," he said.

-- Robert Preidt Copyright © 2012 HealthDay. All rights reserved. SOURCES: Jonathan Haas, M.D., chief, radiation oncology, Winthrop University Hospital, Mineola, N.Y.; Louis Potters, M.D., chairman, radiation medicine, North Shore-LIJ Health System, New Hyde Park, N.Y.; The Lancet, news release, Oct. 18, 2012

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Multivitamin use among middle-aged, older men results in modest reduction in cancer, study finds

ScienceDaily (Oct. 17, 2012) — In a randomized trial that included nearly 15,000 male physicians, long-term daily multivitamin use resulted in a modest but statistically significant reduction in cancer after more than a decade of treatment and follow-up, according to a study appearing in JAMA.

The study is being published early online to coincide with its presentation at the Annual American Association for Cancer Research Frontiers in Cancer Prevention Research meeting.

"Multivitamins are the most common dietary supplement, regularly taken by at least one-third of U.S. adults. The traditional role of a daily multivitamin is to prevent nutritional deficiency. The combination of essential vitamins and minerals contained in multivitamins may mirror healthier dietary patterns such as fruit and vegetable intake, which have been modestly and inversely associated with cancer risk in some, but not all, epidemiologic studies. Observational studies of long-term multivitamin use and cancer end points have been inconsistent. To date, large-scale randomized trials testing single or small numbers of higher-dose individual vitamins and minerals for cancer have generally found a lack of effect," according to background information in the article. "Despite the lack of definitive trial data regarding the benefits of multivitamins in the prevention of chronic disease, including cancer, many men and women take them for precisely this reason."

J. Michael Gaziano, M.D., M.P.H., of Brigham and Women's Hospital and Harvard Medical School, Boston, (and also Contributing Editor, JAMA), and colleagues analyzed data from the Physicians' Health Study (PHS) II, the only large-scale, randomized, double-blind, placebo-controlled trial testing the long-term effects of a common multivitamin in the prevention of chronic disease. The trial includes 14,641 male U.S. physicians, initially age 50 years or older, including 1,312 men with a history of cancer at randomization, who were enrolled in a multivitamin study that began in 1997 with treatment and follow-up through June 1, 2011. Participants received a daily multivitamin or equivalent placebo. The primary measured outcome for the study was total cancer (excluding nonmelanoma skin cancer), with prostate, colorectal, and other site-specific cancers among the secondary end points.

PHS II participants were followed for an average of 11.2 years. During multivitamin treatment, there were 2,669 confirmed cases of cancer, including 1,373 cases of prostate cancer and 210 cases of colorectal cancer, with some men experiencing multiple events. A total of 2,757 (18.8 percent) men died during follow-up, including 859 (5.9 percent) due to cancer. Analysis of the data indicated that men taking a multivitamin had a modest 8 percent reduction in total cancer incidence. Men taking a multivitamin had a similar reduction in total epithelial cell cancer. Approximately half of all incident cancers were prostate cancer, many of which were early stage. The researchers found no effect of a multivitamin on prostate cancer, whereas a multivitamin significantly reduced the risk of total cancer excluding prostate cancer. There were no statistically significant reductions in individual site-specific cancers, including colorectal, lung, and bladder cancer, or in cancer mortality.

Daily multivitamin use was also associated with was a reduction in total cancer among the 1,312 men with a baseline history of cancer, but this result did not significantly differ from that observed among 13,329 men initially without cancer.

The researchers note that total cancer rates in their trial were likely influenced by the increased surveillance for prostate-specific antigen (PSA) and subsequent diagnoses of prostate cancer during PHS II follow-up starting in the late 1990s. "Approximately half of all confirmed cancers in PHS II were prostate cancer, of which the vast majority were earlier stage, lower grade prostate cancer with high survival rates. The significant reduction in total cancer minus prostate cancer suggests that daily multivitamin use may have a greater benefit on more clinically relevant cancer diagnoses."

The authors add that although numerous individual vitamins and minerals contained in the PHS II multivitamin study have postulated chemopreventive roles, it is difficult to definitively identify any single mechanism of effect through which individual or multiple components of their tested multivitamin may have reduced cancer risk. "The reduction in total cancer risk in PHS II argues that the broader combination of low-dose vitamins and minerals contained in the PHS II multivitamin, rather than an emphasis on previously tested high-dose vitamins and mineral trials, may be paramount for cancer prevention. … The role of a food-focused cancer prevention strategy such as targeted fruit and vegetable intake remains promising but unproven given the inconsistent epidemiologic evidence and lack of definitive trial data."

"Although the main reason to take multivitamins is to prevent nutritional deficiency, these data provide support for the potential use of multivitamin supplements in the prevention of cancer in middle-aged and older men," the researchers conclude.

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The above story is reprinted from materials provided by JAMA and Archives Journals.

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Journal Reference:

Gaziano J, Sesso HD, Christen WG, et al. Multivitamins in the Prevention of Cancer in Men: The Physicians' Health Study II Randomized Controlled Trial. JAMA, 2012; DOI: 10.1001/jama.2012.14641

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