Company enrolls first patients in feasibility studies for chronic back pain and wrist osteoarthritis, setting clinical development focus on orthopedic indications
Houston, TX, USA, January 23, 2019 – InGeneron, Inc., a regenerative medicine and cell therapy company, announced today the enrollment of the first patients in two new feasibility studies evaluating InGeneron’s regenerative cell therapy as a way to treat facet joint syndrome, a major cause of chronic back pain, and wrist osteoarthritis. The primary goal of the randomized controlled trials is to demonstrate the safety of the company’s autologous point-of-care cell therapy in treating these indications. The U.S. Food and Drug Administration (FDA) has granted approval of these studies, and patient enrollment has begun. The two new indications complement the company’s lead program in rotator cuff tendinopathy and build upon InGeneron’s focus of developing regenerative cell therapies in musculoskeletal indications.
Facet joint syndrome is an arthritis-like condition of a person’s spine caused by inflammation of the facet joints, leading to degeneration and loss of cartilage. Wrist osteoarthritis can cause bone spurs and cysts in the wrist that lead to cartilage degeneration, inflammation and pain, resulting in reduction of grip strength and a limited range of motion. InGeneron is investigating the use of autologous adipose (fat)-derived regenerative cells (ADRCs) as a therapeutic treatment to potentially provide patients with better options than currently available.
InGeneron’s therapeutic approach involves isolating these cells from patients’ own adipose tissue through a minimally invasive liposuction procedure, processing them with the company’s proprietary technology, and injecting the processed cells in the site of the patient’s injury. Each feasibility study will involve the enrollment of 40 patients and includes a group that receives the cell therapy treatment and a control group that receives a corticosteroid injection. The use of corticosteroids is a current standard of care in the treatment of these indications. Patients enrolled in the studies will be monitored through follow-up visits for 52 weeks following the intervention. More information about the studies is available on ClinicalTrials.gov.
“The start of these two feasibility studies represents the potential to address medical needs among people who suffer from osteoarthritic conditions and is an important milestone on InGeneron’s journey to pioneer regenerative cell therapy,” said Angelo Moesslang, PhD, Chief Executive Officer of InGeneron. “Adding osteoarthritis to our clinical programs represents another step into musculoskeletal indications with high numbers of patients and unmet medical needs, and as a result will add strategic value to the company.”
With the addition of the facet joint syndrome and wrist osteoarthritis studies, InGeneron currently has three ongoing orthopedic programs in place. While the new studies have entered the feasibility phase, 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.
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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