Orgenesis Inc (NASDAQ:ORGS) (FRA:45O) announced that enrollment has commenced for a clinical trial using the company’s Tissue Genesis Icellator in rotator cuff repair surgeries at the Hospital for Special Surgery (HSS) in New York.
The Phase 2 trial, supported by the National Stem Cell Foundation and an Orthopedic Research and Education Foundation grant, will evaluate the safety and efficacy of autologous stromal and vascular fraction cells (SVF) that are injected after surgical rotator cuff repair. The Tissue Genesis Icellator will be utilized for the cell recovery process, the company said.
Orgenesis acquired the Icellator technology in October to supplement its offering of POCare technology systems. It functions as an automated, functionally closed system for the recovery of SVF from autologous adipose (read: fat) tissue. It is designed for use at the point of care, the company said.
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Nine of an eventual 56 total patients have been enrolled so far, the company said.
Rotator cuff disease is one of the most prevalent musculoskeletal conditions, and patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration, the company said. Surgery alone doesn’t reverse the atrophy, and many patients continue to experience weakness and pain.
Published non-clinical and clinical evidence demonstrates that 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 that activate healthy tissue regeneration pathways. SVF has also been shown to modulate inflammation and reduce scarring.
“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,” Orgenesis US POCare General Manager Matthew Lehman said in a statement.
“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.”
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