The trial is supported by the National Stem Cell Foundation and an OREF clinical research grant in cellular therapy in honour of James Urbaniak, MD
Enrollment has commenced for a clinical trial using Orgenesis’ Tissue Genesis Icellator(R) at the Hospital for Special Surgery (HSS) in New York, NY.
The phase 2, randomised, placebo-controlled trial will evaluate safety and efficacy of autologous stromal and vascular fraction cells (SVF) injected after surgical rotator cuff repair. The Tissue Genesis Icellator will be used for the cell recovery process. The trial is planned for 56 patients in total, of which nine have already been enrolled. Scott Rodeo, MD, Professor of Orthopedic Surgery at Weill Cornell Medical College and co-Chief Emeritus of the Sports Medicine Institute at HSS, is the principal investigator. Further details of the trial are available at ClinicalTrials.gov, identifier NCT03332238.
Orgenesis acquired the Icellator technology in October 2020 to supplement its offering of POCare technology systems. The technology is an automated, functionally closed system for recovery of SVF from autologous adipose (fat) tissue. It is designed for use at the point of care.
Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration.
Published nonclinical and clinical evidence reportedly demonstrates SVF from the Icellator may enhance tissue regeneration directly by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate healthy tissue regeneration pathways. It has also been shown to modulate inflammation and reduce scarring.
Scott Rodeo, MD, principal investigator: “I am pleased to lead this trial investigating the efficacy of Icellator-generated SVF in patients after rotator cuff repair. There is a significant clinical need to improve outcomes for these patients and SVF injection has shown promise in early research.”
Matthew Lehman, Orgenesis US POCare General Manager: “We are excited to support this investigator-initiated trial and thank the HSS, the Orthopaedic Research and Education Foundation, and the National Stem Cell Foundation for their involvement. Designed to be used point-of-care, the Tissue Genesis Icellator is a practical and cost-effective solution for clinical applications of SVF. Data from this study may support expanded development of the Icellator in other orthopedic applications.”