The chief medical officer of Celularity discussed MLASC and a new analysis of gene and protein signatures from patients treated in legacy clinical trials that he presented at ASGCT’s 2023 conference.
“...I have said repeatedly that I don't believe the mesenchymal stem cell [MSC] studies have failed, I believe the study designs have failed the MSCs. I think now with our understanding of the mode of action, we can design the end points a lot better [and] we can design the time points a lot better so what we may have are longer studies, but with the appropriate end points.”
Despite a large amount of research and a number of available treatment options, Crohn disease (CD) remains a difficult to manage disease for many patients and physicians. Fistula formation, a common complication associated with CD, remains a particularly difficult problem for these patients.
Seeking to address unmet needs in CD, Celularity previously carried out several phase 1 clinical trials evaluating a placental-derived mesenchymal-like adherent stromal cell therapy approach to treating CD. These legacy trials initially measured efficacy outcomes at early time points, such as 12 weeks or 3 months posttreatment.
In light of newer research elucidating the pathophysiology of fistula formation and the mechanism of action of MSC therapies, Celularity more recently analyzed gene and protein signatures in blood samples from participants in these trials taken at later time points. The results were presented in a talk entitled “Placental-derived mesenchymal-like adherent stromal cell (MLASC) therapy results in alterations in gene and protein signatures associated with inflammation and fistula formation in patients with Crohn’s disease” by Adrian Kilcoyne, MD, MPH, MBA, the chief medical officer of Celularity, at the American Society of Gene and Cell Therapy (ASGCT) 2023 Annual Meeting, held May 16 to 20, in Los Angeles, California.
In an interview with CGTLive™, Kilcoyne discussed the unmet needs in the CD field and the results of the new study. He highlighted that 50% of patients included in the new analysis achieved disease remission at the 2-year time point.