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DiscGenics gained acceptance from FDA for the clinical protocols and Chemistry, Manufacturing, and Controls clinical development plan for the Phase III clinical program of its allogeneic, injectable disc progenitor cell therapy (IDCT) for lumbar degenerative disc disease (DDD), allowing the study to proceed.
The Phase III clinical program agreed upon with the FDA will consist of two identical studies running in parallel: the pivotal study (DGX-A02 or PIVOT) and the confirmatory study (DGX-A03 or CONFIRM). Both studies are randomized, double-blinded, Sham-controlled, multicenter studies in subjects with single-level symptomatic lumbar intervertebral disc degeneration.
Each study will have a one-year primary endpoint with another one-year follow-up period (two-year total duration). The first subject in the pivotal study is estimated to be enrolled during Q4 2024.
“To get to this point has been a long, but very exciting journey. From the early founding of this cell technology by the late Dr. Valery Kukekov to the successful first-in-human clinical evaluation of IDCT, we have become more confident not only around the safety of the cell, but also its regenerative potential,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics. “Our team has been passionately persistent in achieving this important regulatory milestone, which allows us to continue fulfilling our responsibility as stewards of this technology.”
Through this study, IDCT is being evaluated under an investigational new drug (IND) allowance by FDA. If successful, this Phase III clinical program will support a biologics license application to be filed with FDA.
Source: DiscGenics
DiscGenics gained acceptance from FDA for the clinical protocols and Chemistry, Manufacturing, and Controls clinical development plan for the Phase III clinical program of its allogeneic, injectable disc progenitor cell therapy (IDCT) for lumbar degenerative disc disease (DDD), allowing the study to proceed.
The Phase III clinical program...
DiscGenics gained acceptance from FDA for the clinical protocols and Chemistry, Manufacturing, and Controls clinical development plan for the Phase III clinical program of its allogeneic, injectable disc progenitor cell therapy (IDCT) for lumbar degenerative disc disease (DDD), allowing the study to proceed.
The Phase III clinical program agreed upon with the FDA will consist of two identical studies running in parallel: the pivotal study (DGX-A02 or PIVOT) and the confirmatory study (DGX-A03 or CONFIRM). Both studies are randomized, double-blinded, Sham-controlled, multicenter studies in subjects with single-level symptomatic lumbar intervertebral disc degeneration.
Each study will have a one-year primary endpoint with another one-year follow-up period (two-year total duration). The first subject in the pivotal study is estimated to be enrolled during Q4 2024.
“To get to this point has been a long, but very exciting journey. From the early founding of this cell technology by the late Dr. Valery Kukekov to the successful first-in-human clinical evaluation of IDCT, we have become more confident not only around the safety of the cell, but also its regenerative potential,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics. “Our team has been passionately persistent in achieving this important regulatory milestone, which allows us to continue fulfilling our responsibility as stewards of this technology.”
Through this study, IDCT is being evaluated under an investigational new drug (IND) allowance by FDA. If successful, this Phase III clinical program will support a biologics license application to be filed with FDA.
Source: DiscGenics
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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.
