Grant Award Details
- The objective this award is to file an IND application to test the product "Plurocart" (ESC-derived chondrocytes seeded on a matrix) in patients with cartilage damage in the knee.
- The activities to be carried out to achieve this objective are: 1) transfer of manufacturing process and release assays to a contract manufacturing organization; 2) manufacture of GMP-grade master and working cell banks of the parental ESC line; 3) perform engineering and qualification Plurocart manufacturing runs; 4) perform GLP safety/tox and tumorigenicity studies at a contract research organization; 5) perform two GMP manufacturing runs to supply the clinical trial; 6) file the IND application.
Grant Application Details
- Plurocart: a novel stem cell-based implant for articular cartilage restoration
Therapeutic Candidate or Device
Plurocart consists of pluripotent stem cell-derived chondrocytes, seeded onto a scaffold; it is intended to treat damaged cartilage in the knee joint.
Plurocart is intended to be surgically implanted in the knee and regenerate injured cartilage - relieving pain and improving function of the joint.
Plurocart is surgically implanted directly into area of cartilage damage in the knee. Once implanted, the cartilage regenerating cells delivered on the scaffold act by making hyaline cartilage while simultaneously prompting local cells surrounding the defect to participate in repair of the lesion through the secretion essential factors. Consequently, this therapy can replace injured cartilage and prevent further degeneration of the surrounding cartilage in the joint.
Unmet Medical Need
FDA approved treatments for articular cartilage injury are costly, involve complex logistics, and often do not restore functional hyaline cartilage. Plurocart aims to address this need by providing an inexpensive, off-the-shelf therapy with the capacity to regenerate functional hyaline cartilage.
Successful Plurocart IND submission to the FDA
Major Proposed Activities
- Manufacture pluripotent stem cell (PSC)-derived cartilage implants (Plurocart) compliant with the GLP release criteria for tumorigenicity studies
- Assess the potential toxicity, biodistribution and tumorigenicity of Plurocart in an immunocompromised nude rat
- Manufacture of two fully GMP grade compliant lots of Plurocart prior to IND filing and subsequent Phase 1 clinical trial
Plurocart was conceived and developed in the state of California at the University of Southern California. This home-grown cell therapy has the potential to treat cartilage defects and forestall arthritis in our state's citizens. Furthermore, the manufacture of these implants within the state of California has the potential to bring revenue and manufacturing jobs into the state in a highly lucrative biotechnology sector.