Grant Award Details
File an IND with the US FDA by 3/31/2018
Grant Application Details
- Allogenic human adipose-derived mesenchymal stem cells for the treatment of knee osteoarthritis
Therapeutic Candidate or Device
Intra-articularly injected allogeneic culture-expanded human adipose derived mesenchymal progenitor cells
Cartilage regeneration (as determined by cartilage volume increase), immunomodulatory effects
Unmet Medical Need
There is no approved disease modification therapy for osteoarthritis (OA), and OA is a leading cause of both hospitalization and joint replacement surgery. Our product provides symptom relief and structure modification benefits.
Major Proposed Activities
- Manufacture product to supply the proposed trial
- Complete non-clinical safety study requested by the FDA
- File IND
California spends more on osteoarthritis (OA) management than any other state in the union and financial and human cost of OA is expected to worsen with the upward trend in obesity and the ageing baby boomer generation. Our allogenic adipose-derived mesenchymal progenitor cells has the potential to reduce the need for total knee joint replacement, offer a viable regenerative treatment for OA, and significantly reduce healthcare costs in California. .