New Study Reports Broad Applicability of InGeneron’s Regenerative Cell Therapy System Across Patient Groups
HOUSTON--(BUSINESS WIRE)--Jan 6, 2023--
InGeneron, Inc., a clinical stage biotechnology company, announced the publication of a newly released study, titled “The composition of adipose-derived regenerative cells isolated from lipoaspirate using a novel point of care system does not depend on the subject’s individual age, sex, body mass index and ethnicity”, published in the Journal Cells on December 21, 2022. The study, which characterized the composition of regenerative cells isolated from adipose tissue of 232 subjects using InGeneron’s Transpose ® RT system, is the largest such study to date.
Utilizing high-fidelity technology to analyze the final cell product isolated from 232 subjects, the authors concluded the composition, concentration, and viability of regenerative cells were not significantly different across the subject groups that were studied. Additionally, the authors analyzed 37 of the regenerative cell samples using flow cytometry to characterize specific cell types and still found no significant differences between subject groups; sex was not addressed in this sub-analysis.
Dr. Christoph Schmitz, Head of the Department of Anatomy II at Ludwig-Maximilians University (Munich, Germany), Advisory Medical Director of InGeneron and lead author of the paper explains, “It was reasonable for critics of regenerative cell therapy to suspect that the quantity or quality of regenerative cells isolated from a 70-year-old patient might be inferior to those isolated from a 30-year-old patient, resulting in different clinical outcomes between the two patients. However, our study indicates this is not the case. The carefully characterized regenerative cell samples in this study support the conclusion that age, sex, BMI, and ethnicity yield on average similar regenerative cell products across all subject groups.”
“While clinical outcomes often vary based on patient characteristics such as age,” Dr. Schmitz adds, “these results should reduce the concern as to whether patients who undergo autologous regenerative cell therapy might experience different clinical outcomes due to differences in the composition of cells isolated from that patient, which is a breakthrough finding for the field.”
Regarding concentrations of various regenerative cell types within the final cell product, the study found InGeneron’s Transpose ® RT system to isolate the highest concentration of cells known to be important for tissue regeneration compared to similar experimental methods and commercially available systems described in the scientific literature. While the superior quantity of viable cells isolated using InGeneron’s system has been published previously, Dr. Christopher Alt, Director of Medical and Scientific Affairs at InGeneron, and co-author of the new study, states, “We believe this demonstrates the advantage our technology has in isolating the relevant types of regenerative cells, positioning InGeneron’s system as the leader among comparable devices.”
In addition to stem and progenitor cells, the authors highlight the presence of M2 macrophages, which promote healing by reducing inflammation. The concentration of M2 macrophages isolated using InGeneron’s technology are, on average, three times higher than with any other system.
Results of this study emphasize important advantages of InGeneron’s technology, which is currently being evaluated in three actively enrolling FDA-approved clinical trials for the treatment of partial-thickness rotator cuff tears, wrist osteoarthritis and facet joint syndrome.
Citation: Schmitz C, Alt C, Azares AR, Pearce DA, Facile TR, Furia JP, Maffulli N, Huang C, Alt EU. The composition of adipose-derived regenerative cells isolated from lipoaspirate using a point of care system does not depend on the subject’s individual age, sex, body mass index and ethnicity. Cells 2023; 12(1):30.
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.
InGeneron is a clinical-stage biotechnology company developing novel, safe, and evidence-based cell therapies. We are setting new therapeutic standards by enabling minimally invasive treatments that unlock the healing potential of each patient’s own regenerative cells processed at the point of care for same-day treatment. We currently focus on helping patients impacted by orthopedic conditions and are conducting several clinical trials to validate our technology as a disease-modifying treatment. Based on more than 20 years of research, InGeneron is dedicated to developing therapies supported by clinical evidence and approved by the FDA.
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CONTACT: InGeneron, Inc.
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SOURCE: InGeneron, Inc.
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PUB: 01/06/2023 08:23 PM/DISC: 01/06/2023 08:22 PM