U.S. FDA Approves Embryonic Stem Cell Trials

Ian C. Langtree - Writer/Editor for Disabled World (DW)
Published: 2009/01/26 - Updated: 2024/07/04
Publication Type: Announcement
Category Topic: Regenerative Medicine - Academic Publications

Page Content: Synopsis - Introduction - Main

Synopsis: The Food and Drug Administration has approved the use of embryonic stem cells in human trials for the first time. President Barack Obama has said he will sign a bill Congress will likely send him that would force taxpayers to fund embryonic stem cell research, which involves the destruction of human life.

Introduction

The Food and Drug Administration has approved the use of embryonic stem cells in human trials for the first time. While the trials involve controversial embryonic cells that have problems with tumors and immune system rejection, the use of adult stem cells has already proven safe for spinal cord patients.

Main Content

Despite grave concerns that problems such as the causing of tumors and immune system rejection issues haven't been solved, the FDA approved the trials last week. It gave Geron Corp., based in California, permission to conduct the first-ever human trial for a treatment derived from the controversial cells. The trials will involve 10 spinal cord patients. However, the safety of adult stem cell transplants in spinal cord injury patients has already been proved in two clinical trials involving studies in Australia and Portugal.

The Australian research group reported its findings in the August 2008 edition of the medical journal Brain, saying that "transplantation of autologous olfactory en-sheathing cells into the injured spinal cord is feasible and is safe up to one year post-implantation."

In Portugal, a group headed by Carlos Lima also used autologous olfactory stem cell transplants and put them into the spinal lesions of paraplegic and tetraplegic patients.

In a July 2006 Journal of Spinal Cord Medicine article, they wrote that adult stem cells are beginning to offer the most hope for those paralyzed from spinal cord injuries.

Lima's team's adult stem cell research showed restored motor function and sensation in a few paralyzed patients using adult stem cells obtained from a patient's own nose.

Lima and his research team demonstrated that a patient's own adult stem cells and olfactory mucosa can treat paralysis caused by spinal cord injury.

"Every patient had improvement in ASIA motor scores," Lima wrote in his team's paper. "This study shows that olfactory mucosa autograft transplantation into the human injured spinal cord is feasible, relatively safe, and potentially beneficial."

Mark Pickup, a disability rights activist in Canada, commented on the Lima study. He said he wants to see funding of stem cell research go to adult stem cells instead of embryonic because they provide the most hope for paralyzed people like him.

President Barack Obama has said he will sign a bill Congress will likely send him that would force taxpayers to fund embryonic stem cell research, which involves the destruction of human life.

"Not one human therapy has come out of embryonic stem cell research while 72 therapies have come from non-embryonic research," he said. "As someone who can potentially benefit from stem cell therapy (I am triplegic with advanced multiple sclerosis) I want research dollars to go where the most promise lies not the least promise," Pickup added.

Related Information

• New Ethical Framework Introduced for Stem Cell-Based Embryo Research: A groundbreaking code of practice has been introduced for the use of stem cell-based embryo models in research.
• Adult Stem Cells Convert into Embryonic-like Stem Cells: Neural stem cells can take on the characteristics of embryonic stem cells with the addition of a single transcription factor.
• New Guidelines for Stem Cell Research: The stem cell controversy has ruffled the Congress State Legislatures President Bush and the whole of the United Nations.
• UCSF Closer to Creating Safe Embryonic like Stem Cells: Embryonic stem cells have the capacity to become any cell type in the body.
• China Leads the Way in Regenerative Stem Cell Therapy Despite Skepticism: China becoming world leader in stem cell therapy and regenerative medicine despite world skepticism of stem cell therapies.
• Action to Reverse Judicial Embryonic Stem Cell Research Ban: Congressman CSHL president urge quick action to reverse judicial embryonic stem cell research ban.
• Research!America Asks Congress to Support Embryonic Stem Cell Research: Call on Congress to take legislative action that will allow federal funding for human embryonic stem cell research to proceed.

Author Credentials: Ian is the founder and Editor-in-Chief of Disabled World, a leading resource for news and information on disability issues. With a global perspective shaped by years of travel and lived experience, Ian is a committed proponent of the Social Model of Disability-a transformative framework developed by disabled activists in the 1970s that emphasizes dismantling societal barriers rather than focusing solely on individual impairments. His work reflects a deep commitment to disability rights, accessibility, and social inclusion. To learn more about Ian's background, expertise, and accomplishments, visit his full biography.