drugset / Trial / NCT04520945

Phase 2B Clinical Study of Chondrogen for Treatment of Knee Osteoarthritis

NCT04520945

Phase 2 Unknown 100 enrolled Meluha Life Sciences SDN BHD
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary osteoarthritis is a debilitating disease characterized by extensive damage to the joints and excruciating pain leading to loss of activity and depression. Despite advances in diagnosis, the quest for the development of a disease-modifying osteoarthritis drug has proven unsuccessful. Human cartilage only has limited regenerative potential. Transplantation is a promising strategy given the high proliferative capacity of MSCs and their potential to differentiate into cartilage-producing cells - chondrocytes. The acquisition of MSC does not require invasive surgical intervention or cartilage extraction from other sites as required by other cell-based strategies. The investigators inject allogeneic human mesenchymal stem cells to the cartilage lesions in patients via intra-articular injection method, and to investigate the efficacy and safety.

Timeline

Start
2020-10-31
Primary completion
2021-09-30
Completion
2022-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mesenchymal stem cell Cell therapy Other
Comparator Hyaluronic Acid Other / unclassified Other

Indications