GID BIO completed enrollment for the first of two pivotal Phase III studies to investigate the use of a patient’s own stromal vascular fraction cells to treat knee osteoarthritis (OA). The clinical study involves a cellular therapeutic approach delivered in an outpatient setting that takes less than three hours.
The Phase III study was conducted at nine sites across the U.S. A second randomized controlled pivotal Phase III study for knee osteoarthritis is currently under design for initiation this year.
This Phase III study is one of the first multi-site, double-blinded, randomized, controlled trials for a cellular therapy for the treatment of pain and loss of joint function due to OA.
In 2019, the company completed a pivotal Phase IIb clinical trial with an FDA-approved study design using autologous stromal cells in the treatment of knee OA, successfully meeting endpoints and two-year safety results.
“GID BIO has spent 12 years in technology development and clinical evaluation of stromal vascular fraction cells derived from your own adipose tissue. Our completed enrollment of a Phase III study marks a huge accomplishment,” noted William Cimino, Ph.D., CEO of GID BIO. “We will have the Phase III read-out at the end of this year, which we expect will exceed our successful Phase II clinical trial results,” concluded Cimino.
Source: GID BIO, Inc.
GID BIO completed enrollment for the first of two pivotal Phase III studies to investigate the use of a patient’s own stromal vascular fraction cells to treat knee osteoarthritis (OA). The clinical study involves a cellular therapeutic approach delivered in an outpatient setting that takes less than three hours.
The Phase III study was...
GID BIO completed enrollment for the first of two pivotal Phase III studies to investigate the use of a patient’s own stromal vascular fraction cells to treat knee osteoarthritis (OA). The clinical study involves a cellular therapeutic approach delivered in an outpatient setting that takes less than three hours.
The Phase III study was conducted at nine sites across the U.S. A second randomized controlled pivotal Phase III study for knee osteoarthritis is currently under design for initiation this year.
This Phase III study is one of the first multi-site, double-blinded, randomized, controlled trials for a cellular therapy for the treatment of pain and loss of joint function due to OA.
In 2019, the company completed a pivotal Phase IIb clinical trial with an FDA-approved study design using autologous stromal cells in the treatment of knee OA, successfully meeting endpoints and two-year safety results.
“GID BIO has spent 12 years in technology development and clinical evaluation of stromal vascular fraction cells derived from your own adipose tissue. Our completed enrollment of a Phase III study marks a huge accomplishment,” noted William Cimino, Ph.D., CEO of GID BIO. “We will have the Phase III read-out at the end of this year, which we expect will exceed our successful Phase II clinical trial results,” concluded Cimino.
Source: GID BIO, Inc.
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.