Friday, June 5, 2020

Tag: Drug Administration

StemCyte Receives Phase II Investigational New Drug (IND) Clearance from the U.S. Food and...

Published: January 3, 2019

BALDWIN PARK, Calif., Jan. 3, 2019 /PRNewswire/ — StemCyte is pleased to announce that the U.S. Food and Drug Administration (FDA), on December 14, 2018, approved its Phase II Investigational New Drug (IND) application for Allogeneic Human Leukocyte Antigen (HLA)-Matched Umbilical Cord Blood Mononuclear Stem Cells (UCBMNC) (MC001) for the treatment of spinal cord injury.

Q Therapeutics Approved to Start Trial of Cell Therapy Aiming to Restore Myelin

Published: July 26, 2017

A cell therapy intended to boost myelin regeneration — Q-Cells by Q Therapeutics — has received a green light from the U.S. Food and Drug Administration to proceed with a clinical trial in patients with transverse myelitis (TM), a disease that like multiple sclerosis is characterized by myelin damage.

FDA approval of the company’s Investigational New Drug (IND) application allows researchers to start a Phase 1/2 clinical trial in which nine patients will receive increasing doses of the treatment.

Asterias Biotherapeutics Receives FDA Clearance to Enroll C-4 Patients in SCiStar Study

Published: July 10, 2017 | Spinal Cord Injury:

Ability to enroll patients with second most common cervical spinal cord injury broadens eligible population for SCiStar study and future trials

FREMONT, Calif., July 10, 2017 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s amendment to the clinical research protocol for its ongoing AST-OPC1 SCiStar Phase 1/2a clinical trial in motor complete cervical spinal cord injury (SCI). The amendment expands the eligibility criteria to include patients with a C-4 spinal cord injury and extends the dosing window from 14 to 30 days to 21 to 42 days post-injury.

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.

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.

China halts unapproved stem cell treatments as industry grows in country with lighter rules

Published: January 10, 2012

BEIJING — The Health Ministry ordered unapproved stem cell treatments stopped Tuesday as China tries to bring under control its growing but loosely regulated industry.

The ministry stopped accepting applications for stem cell procedures until July and is implementing a yearlong campaign to halt unauthorized stem cell therapy trials.

Geron Is Shutting Down Its Stem Cell Clinical Trial

Published: November 14, 2011

The company conducting the world’s first clinical trial of a therapy using human embryonic stem cells said on Monday that it was halting that trial and leaving the stem cell business entirely.

The company, Geron, said that its move did not reflect a lack of promise for the controversial field. Rather, it said, with money scarce, it had decided to focus on its experimental cancer therapies, which are further along in development.

“I deeply believe in the promise of stem cells,” John A. Scarlett, the chief executive of Geron, said in an interview. “I don’t think that promise is in any way, shape or form changed by what we’re doing.”

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