Thursday, April 2, 2020

Tag: FDA

UM’s Miami Project gets FDA approval for clinical paralysis trial

Published: July 31, 2012

The FDA’s go-ahead makes The Miami Project’s clinical trial to aid against spinal cord injury the only one in the United States.

The Miami Project to Cure Paralysis said Tuesday it has received federal approval to conduct “revolutionary” human trials to transplant a patient’s own Schwann cells, found mainly in the nervous system, to the site of recent spinal cord injuries in the hope that the trials may bring researchers closer to finding a cure for paralysis.

Lyrica Approved for Spinal Neuropathic Pain

Published: June 25, 2012

The Food and Drug Administration has approved the use of Lyrica for the management of neuropathic pain associated with chronic, debilitating spinal cord injuries. Lyrica, the brand name for pregabalin, is manufactured by Pfizer (NYSE: PFE) and is already widely used to treat fibromyalgia pain.

According to Pfizer, about 40 percent of the 270,000 Americans with spinal cord injuries suffer from chronic neuropathic pain that they describe as severe or excruciating. An estimated 12,000 new spinal cord injury patients are diagnosed in the U.S.each year.

InVivo Therapeutics Protects And Regenerates The Spinal Cord Resulting in Functional Improvement Below the...

Published: June 21, 2012 | Spinal Cord Injury:

Frank Reynolds, of InVivo Therapeutics (NVIV), says the company is on the verge of unprecedented technology for the treatment of the spinal cord. The Massachusetts-based medical device company is developing regenerative and neuroprotective technologies for the treatment of spinal cord injuries. It is the first company in history to successfully demonstrate functional improvement in a paralyzed non-human primate.

Below OneMedRadio interviews Reynolds where he speaks candidly about his own injury rendering him a paraplegic, and the passion behind his work. Reynolds will be presenting InVivo’s technology at OneMedForum New York on July 12, 2012.

Promising new therapy could ‘cure’ paralyzed patients

Published: March 14, 2012

Dr. W. Dalton Dietrich, scientific director of the Miami Project to Cure Paralysis, was in Washington this week seeking U.S. Food and Drug Administration approval to start a clinical safety trial of a remarkable new therapy for those suffering from brain and spinal cord injuries.

The Miami Project was co-founded 26 years ago by neurosurgeon Barth Green and Hall of Fame middle linebacker Nick Buoniconti, who led the 1972 Miami Dolphins’ legendary No Name Defense — the only NFL team to win the Super Bowl after a perfect season.

In 1985, Buoniconti’s son, then a 19-year-old sophomore at the Citadel, severed his spinal cord during a college football game. Now 44 and president of the Miami Project, Marc Buoniconti is a quadriplegic who uses a motorized, breath-operated wheelchair to get around.

Where Does Geron’s Exit from Embryonic Stem Cells Leave the Field?

Published: November 28, 2011

Given that the firm with the most money has just quit, questions about how to succeed are rampant.

Geron, a pioneer in stem cell research founded in 1990, announced on November 14 that it was halting its stem cell therapeutics programs to conserve funds. It plans on laying off 38% of its 175-person staff and is seeking partners to take on the programs’ assets.

Geron had been developing cell products from differentiated human embryonic stem cells (hESCs) for multiple indications. The company is viewed as the leader in stem cell therapies because of its patents on technology used to grow, manipulate, and inject stem cells into the human body. It helped finance researchers at the University of Wisconsin who first isolated human embryonic stem cells in 1998, allowing the cells to be grown in the laboratory.

Working2Walk 2011, Anthony Caggiano (Acorda)

Published: October 24, 2011

The Challenges of Chondroitinase Development for Spinal Cord Injury

Working2Walk 2011, W. Dalton Dietrich, PhD

Published: October 20, 2011

THE MIAMI PROJECT TO CURE PARALYSIS: CURRENT STUDIES TARGETING THERAPEUTIC HYPOTHERMIA AND SCHWANN CELL TRANSPLANTATION

Preliminary Human Experiments to Test Safety of Nerve Cell Transplants for Spinal Cord Paralysis

Published: October 19, 2011

The new approach, currently being studied by the FDA for phase I trials, avoids the problems of immunological rejection and the controversy around the use of embryonic stem cells

ROCKVILLE, Md.—A new experiment aimed at achieving actor Christopher Reeve​’s dream of finding an effective treatment for spinal paralysis was announced this week at an international meeting of scientists and people with spinal cord injury sponsored by the United 2 Fight Paralysis Foundation. The approach, which already is shown to be promising in animals and avoids the need for patients to take immunosuppressive drugs, has not yet been proved effective in humans. Nonetheless, patients are excited to see this advance as they have been frustrated waiting for the first human trials of the new approach.

A New Hope for Treating Spinal Cord Injury: 5 Points on InVivo Therapeutics’ Technology

Published: October 11, 2011

InVivo Therapeutics, based in Cambridge, Mass., was founded to focus on research and development of treatment for patients with spinal cord injuries (SCI). Currently, there are no effective treatments for these patients, and much of the research focuses on treating the symptoms of SCI instead of the underlying pathology.

However, InVivo has focused its efforts on both regenerative medicine and neuroprotection. Its scaffolds are designed to mitigate inflammation and prevent further cell death after SCI as well as support the repair and neuroplasticity recovery process.

FDA Approves Botox to Treat Specific Form of Urinary Incontinence

Published: August 24, 2011

SILVER SPRING, Md., Aug. 24, 2011 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.

Uninhibited urinary bladder contractions in people with some neurological conditions can lead to an inability to store urine. Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empty the bladder.

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