GID BIO welcomes director of clinical operations
We tapped Sandeep Samudre, PhD, MPH, to lead our trial operations including the pivotal Phase III trial for knee osteoarthritis and other efforts in our pipeline across all sites such as New Jersey Institute of Regenerative Medicine, Tulane University and Wake Forest Institute for Regenerative Medicine led by Dr. Jay Bowen, DO, Dr. Jaime Garza, […]
Dr. Manish Gupta joins the GIDOA-3 team
Dr. Manish Gupta, an orthopaedic surgeon with a sports medicine focus enters as GID BIO’s newest principal investigator in a pivotal Phase III trial of the GID SVF-2 technology platform’s point-of-care cellular therapy for knee osteoarthritis. Our Phase IIb study results for patients who received the cellular therapy (from autologous, adipose-derived stromal vascular fraction cells) […]
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 […]
Orlando Medical News features GID BIO and pivotal/Phase III trial
San Antonio Business Journal 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 […]
Denver Business Journal 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 […]
