Houston, TX, USA and Munich, Germany, November 21, 2016 – InGeneron, Inc., a regenerative medicine and biotechnology company, today announced the presentation of initial data from an investigator initiated case series using its proprietary adipose-derived regenerative cell (ADRC) technology for the treatment of facet joint syndrome, one of the major causes of chronic back pain. The results discussed in an oral presentation at the meeting of the International Federation for Adipose Therapeutics and Science (IFATS) in San Diego, California, provide a first indication of clinical benefit as well as a favorable safety profile for autologous regenerative cells in the treatment of facet joint syndrome. Facet joint syndrome, often referred to as osteoarthritis, is one of the main causes of chronic back pain and describes the degeneration of the motion segment in the spine, which leads to chronic inflammation and pain.
“Regenerative cells have great potential to improve treatment outcomes in many orthopedic indications and the data presented at IFATS are a first step towards building the clinical validation for this promising therapeutic approach,” said Michael Coleman, PhD, Chief Executive Officer of InGeneron. “We are very committed to further solidifying clinical evidence of how these cells impact inflammation and pain as well as support healing with an initial focus on key orthopedic procedures and wound healing.”
The case series comprised 19 male patients ranging in age from 31 to 71 years presenting with facet joint syndrome and treated with autologous ADRCs prepared at point of care through InGeneron’s proprietary technology. Patients reported a significant average pain decrease from 7.2 to 1.8 on a Visual Analogue Scale (VAS) and an Oswestry Disability Index (ODI) reduction from 74.3% to 19.1%. Over the average follow-up period of 13.2 months post treatment, patients reported continued pain reduction, and no adverse events occured, demonstrating good overall safety and tolerability.
“It is encouraging to see what is a drastic reduction in pain for the majority of patients in the study, especially since, as the condition grows worse, people suffering from this syndrome have fewer treatment options,” commented Ralf Rothörl, MD, PhD, Director of the Department of Neurosurgery at ISAR Klinikum Munich, Germany, who led the study. “The results of the case series show how autologous ADRCs can be used for the regulation of inflammatory responses in this indication, providing a basis for further research into other similar orthopedic indications as well.”
In a second oral presentation at the conference, InGeneron and its collaborators investigated the bone formation potential of regenerative cells in a preclinical study conducted in a rat spinal fusion model. The study showed that both alone and in combination with FDA-approved rhBMP2 therapy, regenerative cells from InGeneron’s proprietary technology prepared at point of care could induce formation of new bone, resulting in spinal fusion.
The regenerative cell therapeutics described in both studies are prepared from adipose tissue through a liposuction from abdominal fat which is more accessible and a less severe intervention than extracting regenerative cells from bone marrow. The sample is then processed through the InGeneron Transpose® RT System and proprietary Matrase™ enzymatic reagent for immediate therapeutic application within 60 minutes, positioning the system for easy integration with many standard operating room procedures.
The abstracts of both presentations can be found in the IFATS 2016 program. The presentations are available as PDF for the case series on chronic back pain preclinical study in a rat spinal fusion model.
About the Transpose® RT System and FDA approved 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 in less than 90 minutes 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.
Eckhard Alt, MD, PhD
Executive Chairman of InGeneron
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