The FDA approval process is important for patient safety and cell therapy research
In 2017, the Food and Drug Administration gave for-profit stem cell clinics three years to engage the regulatory approval process to establish the safety and efficacy of their investigational products. An analysis from leading bioethicist Leigh Turner, Ph.D., has found more of these businesses in the US today than in 2017. Many of these clinics claim their […]
Two new employees join GID BIO team
GID BIO welcomes two new employees to the team as the newest of eight trial sites begin gearing up to enroll patients to participate in its pivotal Phase III trial: “Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis.” More sites will be added to our existing sites. Committed to continuing to follow a […]
FDA announces consolidation of regulatory oversight responsibilities for fat transfer devices that process adipose tissue for return to the body
The proper surveillance of medical devices is necessary to ensure the health and safety of the public, and the Food and Drug Administration is committed to accuracy in oversight. The FDA has recently announced a consolidation of regulatory oversight responsibilities for fat transfer devices that process adipose tissue for return to the body within the […]
Professional athletes-turned physicians discuss the importance of cell therapy on The Ortho Show
Listen to former NFL players Jaime Garza, MD, DDS, FACS, one of GID BIO’s principal investigators, and Jim Kovach, MD, JD, as they reunite onThe Ortho Show, to discuss the treatment gap between pain management and major surgery and cell therapy’s potential to one day fill that gap. The treatment gap is real. Patients use pain medications to […]
<i>Orlando Medical News</i> features GID BIO and pivotal/Phase III trial
<i>San Antonio Business Journal</i> features GID BIO and pivotal/Phase III trial principal investigator, Dr. Jaime Garza: “On the forefront of new cell therapy research, an Alamo City surgeon has a key role in moving new medical technology to market”
GID BIO completed a pivotal Phase IIb clinical trial with an FDA-compliant study design using autologous stromal cells in the treatment of knee osteoarthritis (OA), successfully meeting endpoints and two-year safety results… Read more via ORTHOWORLD: https://www.orthoworld.com/index.php/publications/orthoflash/gid-bio-completes-trial-of-stromal-cells-to-treat-knee-oa
GID BIO begins pivotal/Phase III clinical trial patient enrollment process at Texas Center for Cell Therapy and Research in San Antonio
This summer, the FDA cleared our stromal-vascular-fraction cellular therapy for a pivotal/Phase III clinical trial to test its safety and efficacy in the treatment of knee osteoarthritis. Three initial sites were secured and announced in Denver Business Journal: Tulane University School of Medicine, Texas Center for Cell Therapy and Research in San Antonio, and New […]
<i>Denver Business Journal</i> features GID BIO: “Colorado biotech firm’s new cell therapy could eliminate the need for knee replacements”
As the total number of confirmed COVID-19 cases surpasses five million in the US, companies across the country are researching potential diagnostic tests, vaccines and treatment options. With recent clearance from the FDA, our team joins the force of a limited number of cell and gene therapies being studied in FDA clinical trials. This potential […]
GID BIO welcomes business titan, Roy J. Bostock as new board chair
Our team announced that Roy J. Bostock, a global business leader with decades of experience, has been elected as the new chair of our board. “I’m thrilled to join this visionary biotech company that could have an enormous impact on medicine,” said Bostock. “The future of medicine is cellular therapy and the GID BIO team […]
Physicians: advancing the future of evidence-based cellular therapy could increase quality of life for 14 million US adults suffering from knee osteoarthritis
Over the past three decades cardiothoracic procedures have significantly shifted to minimally invasive techniques with new technology, training of physicians and an ecosystem for workforce development. Orthopedics is on the forefront of a similar shift. Fourteen million U.S. adults suffer from knee osteoarthritis and professional athletes are driving a demand for alternative treatments to surgery, despite many being unsupported […]
