Phase 1Completed
Impact of Mesenchymal Stem Cells in Knee Osteoarthritis
A Phase I Single Center Open Study to Assess the Safety and Efficacy of Intra-articular Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis and Chondral Defects of the Knee
- Sponsor
- University Hospitals Cleveland Medical Center (Academic or other)
- Enrolment
- 16 enrolled
- Conditions
- Musculoskeletal Pain; Knee Osteoarthritis; Cartilage Injury; Cartilage Degeneration
- Interventions
- Autologous Mesenchymal Stem Cells
- Ages
- adults
- Registry
- NCT03477942
From the registry
Many patients with osteoarthritis of the knee fail non-operative measures and elect to have knee arthroplasty to improve their quality of life. If successful, intra-articular mesenchymal stem cell (MSC) injections into the knee may offer another viable non-operative treatment modality. Additionally, this modality may have reparative or regenerative potential, which could lead to the first treatment for osteoarthritis that treats the underlying disease as opposed to symptomatic control. Additionally, there are no acceptable non-surgical treatments for focal chondral defects of the knee. Surgical treatments that do exist have diminished outcomes if performed on patients older than age 30-40 years. If successful, intra-articular MSC injections into the knee would represent the first non-operative treatment for focal chondral defects and also represent a potential option for treatment in patients over the age of 30-40 years. This trial will be a prospective, single-center phase I pilot study to evaluate the safety and tolerability of a single intra-articular injection of autologous…
Primary outcomes
- Primary Endpoint: Incidence of treatment emergent major adverse events directly related to MSC injection