Autologous point-of-care regenerative cell therapy shows favorable safety profile and promising histological outcome in clinical case study of guided bone regeneration
Houston, TX, USA, March 21, 2019 – InGeneron, Inc., a regenerative medicine and cell therapy company based in Houston and Munich, announced today the publication of results from an investigator-initiated case report using its autologous adipose-derived regenerative cell (ADRC) technology in guided bone regeneration. A 79-year old patient underwent jaw bone augmentation prior to the placement of dental implants and was treated with a bilateral external sinus lift procedure as well as a bilateral lateral alveolar ridge augmentation. One side of the patient’s jaw was administered with a combination of ADRCs, isolated and prepared using InGeneron’s point-of-care cell therapy platform, as well as fraction 2 of plasma rich in growth factors (PRGF-2), and an osteoinductive scaffold. The other side of the patient’s jaw was treated with PRGF-2 and a scaffold only. A comparison of histological data, gathered from tissue biopsies on each side of the patient’s jaw six and 34 weeks after the procedure, indicates that the ADRC treatment is safe and well-tolerated and, additionally, that it leads to better and faster bone regeneration compared to the site treated with PRGF-2 and a scaffold only.
The case report was conducted in collaboration with Principal Investigator Dr. med. dent. Önder Solakoglu, MCD, MSc, and was published in the World Journal of Stem Cells. The publication, titled “Improved guided bone regeneration by combined application of unmodified, fresh autologous adipose derived regenerative cells and plasma rich in growth factors: A first-in-human case report and literature review”, can be accessed through this link.
InGeneron’s therapeutic approach involves isolating regenerative cells from a patient’s own adipose tissue through a minimally-invasive liposuction procedure, processing them with the company’s proprietary technology, and locally injecting the isolated cells into the site of the patient’s injury. The autologous therapy is an outpatient procedure performed at the bedside, and takes about two hours, start to finish.
“Despite this being very early data, the report shows promising potential for applications of InGeneron’s therapeutic approach in guided bone regeneration”, said Glenn Winnier, PhD, Chief Scientific Officer of InGeneron. “The histological analysis of patient biopsies in this case study, indicating the stimulatory potential of ADRCs in bone tissue regeneration, is an encouraging signal for further research.”
InGeneron currently has three ongoing clinical programs in place. With a focus on musculoskeletal indications, the company’s clinical lead program in rotator cuff tendinopathy is set to progress with a double-blinded, multi-center pivotal study this year, aiming to enroll 246 patients. Top-line data of InGeneron’s rotator cuff feasibility study, which was reported in December 2018, can be found on the company’s website. Earlier this year, InGeneron announced the enrollment of the first patients in two additional studies for chronic back pain and wrist osteoarthritis.
Solakoglu Ö, Götz W, Kiessling MC, Alt C, Schmitz C, Alt EU. Improved guided bone regeneration by combined application of unmodified, fresh autologous adipose derived regenerative cells and plasma rich in growth factors: A first-in-human case report and literature review. World J Stem Cells 2019; 11(2): 124-146
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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