Category Archives: FDA Stem Cell Trials

By Matt Smith, CNN updated 7:06 PM EST, Thu February 27, 2014 STORY HIGHLIGHTS (CNN) -- A promising way to stop a deadly disease, or an uncomfortable step toward what one leading ethicist called eugenics? U.S. health officials are weighing whether to approve trials of a pioneering in vitro fertilization technique using DNA from three people in an attempt to prevent illnesses like muscular dystrophy and respiratory problems. The proposed treatment would allow a woman to have a baby without passing on diseases of the mitochondria, the "powerhouses" that drive cells. The procedure is "not without its risks, but it's treating a disease," medical ethicist Art Caplan told CNN's "New Day" on Wednesday. Preventing a disease that can be passed down for generations would be ethical "as long as it proves to be safe," he said. "These little embryos, these are people born with a disease, they can't make power. You're giving them a new battery. That's a therapy. I think that's a humane ethical thing to do," said Caplan, the director of medical ethics at New York University's Langone Medical Center. "Where we get into the sticky part is, what if you get past transplanting batteries and start to … Continue reading →

A promising way to stop a deadly disease, or an uncomfortable step toward what one leading ethicist called eugenics? U.S. health officials are weighing whether to approve trials of a pioneering in vitro fertilization technique using DNA from three people in an attempt to prevent illnesses like muscular dystrophy and respiratory problems. The proposed treatment would allow a woman to have a baby without passing on diseases of the mitochondria, the "powerhouses" that drive cells. The procedure is "not without its risks, but it's treating a disease," medical ethicist Art Caplan told CNN's "New Day" on Wednesday. Preventing a disease that can be passed down for generations would be ethical "as long as it proves to be safe," he said. "These little embryos, these are people born with a disease, they can't make power. You're giving them a new battery. That's a therapy. I think that's a humane ethical thing to do," said Caplan, the director of medical ethics at New York University's Langone Medical Center. "Where we get into the sticky part is, what if you get past transplanting batteries and start to say, 'While we're at it, why don't we make you taller, stronger, faster or smarter?' " … Continue reading →

Workers in a fertility clinic prepare to freeze an embryo. (CNN) A promising way to stop a deadly disease, or an uncomfortable step toward what one leading ethicist called eugenics? U.S. health officials are weighing whether to approve trials of a pioneering in vitro fertilization technique using DNA from three people in an attempt to prevent illnesses like muscular dystrophy and respiratory problems. The proposed treatment would allow a woman to have a baby without passing on diseases of the mitochondria, the powerhouses that drive cells. The procedure is not without its risks, but its treating a disease, medical ethicist Art Caplan told CNNs New Day on Wednesday. Preventing a disease that can be passed down for generations would be ethical as long as it proves to be safe, he said. These little embryos, these are people born with a disease, they cant make power. Youre giving them a new battery. Thats a therapy. I think thats a humane ethical thing to do, said Caplan, the director of medical ethics at New York Universitys Langone Medical Center. Where we get into the sticky part is, what if you get past transplanting batteries and start to say, While were at it, … Continue reading →

Posted on: 11:08 am, February 27, 2014, by CNN Wire, updated on: 12:00pm, February 27, 2014 A promising way to stop a deadly disease, or an uncomfortable step toward what one leading ethicist called eugenics? U.S. health officials are weighing whether to approve trials of a pioneering in vitro fertilization technique using DNA from three people in an attempt to prevent illnesses like muscular dystrophy and respiratory problems. The proposed treatment would allow a woman to have a baby without passing on diseases of the mitochondria, the powerhouses that drive cells. The procedure is not without its risks, but its treating a disease, medical ethicist Art Caplan told CNNs New Day on Wednesday. Preventing a disease that can be passed down for generations would be ethical as long as it proves to be safe, he said. These little embryos, these are people born with a disease, they cant make power. Youre giving them a new battery. Thats a therapy. I think thats a humane ethical thing to do, said Caplan, the director of medical ethics at New York Universitys Langone Medical Center. Where we get into the sticky part is, what if you get past transplanting batteries and start to … Continue reading →

By Matt Smith, CNN updated 7:06 PM EST, Thu February 27, 2014 STORY HIGHLIGHTS (CNN) -- A promising way to stop a deadly disease, or an uncomfortable step toward what one leading ethicist called eugenics? U.S. health officials are weighing whether to approve trials of a pioneering in vitro fertilization technique using DNA from three people in an attempt to prevent illnesses like muscular dystrophy and respiratory problems. The proposed treatment would allow a woman to have a baby without passing on diseases of the mitochondria, the "powerhouses" that drive cells. The procedure is "not without its risks, but it's treating a disease," medical ethicist Art Caplan told CNN's "New Day" on Wednesday. Preventing a disease that can be passed down for generations would be ethical "as long as it proves to be safe," he said. "These little embryos, these are people born with a disease, they can't make power. You're giving them a new battery. That's a therapy. I think that's a humane ethical thing to do," said Caplan, the director of medical ethics at New York University's Langone Medical Center. "Where we get into the sticky part is, what if you get past transplanting batteries and start to … Continue reading →

By Matt Smith, CNN updated 7:06 PM EST, Thu February 27, 2014 STORY HIGHLIGHTS (CNN) -- A promising way to stop a deadly disease, or an uncomfortable step toward what one leading ethicist called eugenics? U.S. health officials are weighing whether to approve trials of a pioneering in vitro fertilization technique using DNA from three people in an attempt to prevent illnesses like muscular dystrophy and respiratory problems. The proposed treatment would allow a woman to have a baby without passing on diseases of the mitochondria, the "powerhouses" that drive cells. The procedure is "not without its risks, but it's treating a disease," medical ethicist Art Caplan told CNN's "New Day" on Wednesday. Preventing a disease that can be passed down for generations would be ethical "as long as it proves to be safe," he said. "These little embryos, these are people born with a disease, they can't make power. You're giving them a new battery. That's a therapy. I think that's a humane ethical thing to do," said Caplan, the director of medical ethics at New York University's Langone Medical Center. "Where we get into the sticky part is, what if you get past transplanting batteries and start to … Continue reading →

Posted on: 8:44 pm, February 26, 2014, by CNN Wire, updated on: 08:45pm, February 26, 2014 (CNN) A promising way to stop a deadly disease, or an uncomfortable step toward what one leading ethicist called eugenics? U.S. health officials are weighing whether to approve trials of a pioneering in vitro fertilization technique using DNA from three people in an attempt to prevent illnesses like muscular dystrophy and respiratory problems. The proposed treatment would allow a woman to have a baby without passing on diseases of the mitochondria, the powerhouses that drive cells. The procedure is not without its risks, but its treating a disease, medical ethicist Art Caplan told CNNs New Day on Wednesday. Preventing a disease that can be passed down for generations would be ethical as long as it proves to be safe, he said. These little embryos, these are people born with a disease, they cant make power. Youre giving them a new battery. Thats a therapy. I think thats a humane ethical thing to do, said Caplan, the director of medical ethics at New York Universitys Langone Medical Center. Where we get into the sticky part is, what if you get past transplanting batteries and start … Continue reading →

U.S. medical advisers are considering whether there is scientific justification for allowing human studies of a controversial procedure known as "three-parent in vitro fertilization (IVF)," a technique supporters say could prevent horrific genetic defects but that critics believe could lead to designer babies. During two days of public hearings starting on Tuesday, scientists were scheduled to present their research to outside advisers to the U.S. Food and Drug Administration. The agency will decide whether safety concerns raised by three-parent IVF are minimal enough to allow clinical trials to begin. The committee is focusing only on the science, and at the end of Tuesday's hearing some committee members expressed concern that animal research cannot yet show that human studies would be safe for women and any children born via the three-parent technique. Several panelists felt "there was probably not enough data in animals . . . to move on to human trials without answering a few additional questions" about safety, said committee chairman Dr. Evan Snyder of the Sanford/Burnham Medical Research Institute in La Jolla, California, in summarizing their views at the end of Tuesday's session. Although the panel has not been asked to consider legal or ethical issues, members of … Continue reading →

NEW YORK - U.S. medical advisors are weighing whether there is scientific justification for allowing human studies of a controversial procedure known as "three-parent in vitro fertilization (IVF)," a technique supporters say could prevent horrific genetic defects, but critics believe could lead to designer babies. Over two days of public hearings starting on Tuesday, scientists were scheduled to present their research to outside advisors to the U.S. Food and Drug Administration. The agency will decide whether safety concerns raised by three-parent IVF are minimal enough to allow clinical trials to begin. The committee is focusing only on the science, not the legal or ethical issues, Celia Witten of the FDA's Office of Cellular, Tissue and Gene Therapies said in comments introducing the hearing. That did not stop members of the public from focusing on ethical issues. Speakers warned the panel that use of three-parent IVF "could alter the human species," represented "an unprecedented level of experimentation on non-consenting human subjects" (meaning any children born via the technique), and "could open the door to genetically-modified children" who would be "manufactured products." In the three-parent procedure, one man would donate sperm and all its DNA for in vitro fertilization. The would-be biological … Continue reading →

IRVINE, Calif.--(BUSINESS WIRE)--California Stem Cell, Inc. (CSC) announced today that the U.S. Food and Drug Administration (FDA) has approved the Companys application to begin a Phase II clinical trial exploring the potential of a patient-specific cancer immunotherapy in women with Stage III or IV ovarian, fallopian tube or primary peritoneal cancer. The randomized, double-blind study is the Companys second cancer therapy approved for clinical trials by the FDA, bolstering its platform approach to treating late stage solid-tumor cancers. The Companys patient-specific approach to treating metastatic melanoma, recently approved to begin a Phase III trial, provided sufficient safety data to proceed directly to a Phase II study in ovarian cancer. Led by Chief Medical Officer Robert Dillman, M.D., the study design randomizes an estimated 99 adult female patients to two treatment arms. The treatment group will receive Ovapuldencel-T, which is a combination of autologous dendritic cells loaded with irradiated autologous tumor cells in GM-CSF. Ovapuldencel-T is created by first isolating cancer stem cells from the patient's resected tumor sample, then enriching, inactivating and combining these cells with dendritic cells or antigen-presenting immune cells which are harvested from the patients blood. The control group will receive the MC treatment, harvested from the … Continue reading →