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InGeneron Announces Critical In-Depth Analysis of the Results from a Recently Published 480-Patient Phase III Knee Osteoarthritis Trial

The data presentation and discussion in the recently published MILES study yield more questions than answers regarding the optimal treatment for knee osteoarthritis

InGeneron, Inc., a clinical stage biotechnology company, announces a critical in-depth analysis of the results from a 480-patient Phase III knee osteoarthritis (OA) trial that was recently published in the Journal Nature Medicine on November 2nd, 2023. The original study, entitled “Cell based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial”, aimed to investigate the therapeutic effectiveness of InGeneron’s regenerative cell therapy in comparison to two other orthobiologic treatments and the conventional corticosteroid injection for knee OA.

Importantly, the study reported no serious treatment-related adverse events from any of the 109 patients treated with InGeneron’s Transpose® RT cell therapy system.

A critical in-depth analysis titled “Management of Knee Pain in Osteoarthritis with Orthobiologics and Corticosteroid Injection: More Questions than Answers” was published on November 16th by Drs. Christoph Schmitz, Christopher Alt and Eckhard U. Alt.

The authors came to the following conclusion (cited from the abstract):

“The [original] study concluded that, one-year post-treatment, all orthobiologic therapies examined were equivalent in effectiveness to each other and to corticosteroid injections.

“While we commend the scope and methodological rigor of the trial, the publication could be enhanced by a more comprehensive presentation of data to support the conclusions drawn. Particularly, the omission of baseline data for primary outcomes, the missing context to evaluate absolute values, and the lack of discussion regarding interindividual variability is of concern.

“Also of note, are the surprisingly positive results reported for patients treated with corticosteroid injections, which severely contradict established literature findings (e.g., Orchard, Osteoarthritis Cartilage 2023;31(2):142-143); and are as such less suitable to support the supposed main finding of the study that orthobiologics would not be more helpful than corticosteroid injections. The release of supplementary data could facilitate a comprehensive understanding and better utilization of this rich dataset.”

Specifically, the in-depth analysis raises the question whether a more differentiated analysis of patient sub-populations might have found a different result. The analysis suggests, “Additional sub-group analyses would have provided important information not only for the main conclusion of the Nature Medicine publication, but also for the design of follow-up studies.” Such a sub-group analysis seems necessary considering the rise of knee replacements in most countries as knee OA prevalence itself is driven by longer life expectancies worldwide (Orchard, 2023).

Publication Details

Citation: Schmitz, C., Alt, C. & Alt, E.U. Management of knee pain in osteoarthritis with orthobiologics and corticosteroid injection: more questions than answers. Preprints doi:10.20944/preprints202311.1081.v1

About the Transpose® RT System and Current Clinical Trials

InGeneron’s Transpose® RT cell therapy platform consists of a processing unit, a set of disposables, and Matrase™, a proprietary enzyme mixture. The platform allows the isolation of regenerative cells from the patients’ own adipose tissue at point-of-care for same-day treatment. The cells are re-administered into the patient’s damaged tissue by injection under ultrasound or fluoroscopic guidance.

The Transpose® RT System is being investigated in several FDA-approved clinical trials and is currently available in the U.S. for research use only. More information on InGeneron’s actively enrolling clinical trials can be found at www.clinicaltrials.gov under the identifiers NCT03752827, NCT03513731, and NCT03503305.

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