A patient with a spinal cord injury was injected with human stem cells—marking the start of the first clinical trial of a human stem-cell therapy, one that could potentially help paralyzed people walk and control certain bodily functions.
US researchers have started the first official trial use of human embryonic stem cells in treating patients with spinal injury after FDA officials gave them the green light.
While stem cell researches are being conducted in different parts of the world, embryonic stem cell therapy has been a major source of controversy and political drama in the United States.
President George W. Bush banned federal funding for research in this field in his first term due to ethical concerns. The Obama administration, however, overturned the ban in late August.
The Food and Drug Administration (FDA) granted Geron, a biotech company based in “silicon valley” south of San Francisco, a license to use the potentially lifesaving cells to treat patients with spinal injuries.
The Shepherd Center in Atlanta, therefore, became the first place in the US to conduct such procedure. Northwestern Medicine in Chicago is reported to be the second center aiming to enroll human subjects for a similar trial.
The US-government-approved trial aims to use stem cells, which have the potential to become different types of cells, to develop nerve cells to be injected into the spinal cord within 14 days of the injury.
The current Phase I trial mainly aims to assess the safety of using embryonic stem cells in this context. Scientists, hence, hope they would widely use the technique to treat affected patients if the present study approves the effectiveness of the strategy.
“When we started working with human embryonic stem cells in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials,” said Geron president Dr Thomas Okarma.
“This is indeed a significant milestone in our journey towards the promise of stem cell-based medicines,” said Ben Sykes, executive director of the UK National Stem Cell Network.
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