GID BIO completes enrollment for randomized double-blinded pivotal Phase III cell therapy study for treatment of knee osteoarthritis

LOUISVILLE, Colo., Feb. 12, 2024 /PRNewswire/ -- GID BIO, Inc. completed enrollment for the first of two pivotal Phase III studies to investigate the use of your own stromal vascular fraction (SVF) cells to treat osteoarthritis of the knee. The clinical study involves a cellular therapeutic approach delivered in an outpatient setting that takes less than three hours.

This Phase III study is one of the first multi-site, double-blinded, randomized, controlled trials for a cellular therapy for treatment of pain and loss of joint function due to osteoarthritis. A Phase III study is used to produce the highest level of clinical evidence which can be used to support regulatory approvals in the US.

The huge unmet need for osteoarthritis therapy is for a durable therapeutic approach that addresses the significant joint pain and loss of joint mobility resulting from the chronic degenerative disease. Current therapies for management of osteoarthritis pain include drugs and joint injections, both with limited impact on pain and only short-term durability. The only approved durable treatment for severe knee osteoarthritis is major surgery for joint replacement, which ranks among the top 10 most common surgical procedures and associated healthcare expenses.

“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.

The Phase III study was conducted at nine sites across the US. A second randomized controlled pivotal Phase III study for knee osteoarthritis is currently under design for initiation this year.

About GID BIO, Inc.
GID BIO is a regenerative medicine company that delivers evidence-based clinical outcomes using a patient’s own healing cells. GID BIO therapeutic applications currently in development include treatment for degenerative disease of the musculoskeletal system and chronic degenerative conditions of the pulmonary and neuro systems.

Contact: Kellee Johnson, 312-751-3959, kjohnson@ballastgroup.com

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SOURCE GID BIO