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Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis
Sponsor: DuoGenic StemCells Corporation (DGSC)
Summary
The goal of this Phase II/III, double-blinded, multicenter clinical trial is to assess the clinical efficacy of autologous peripheral blood mononuclear cells (PBMCs) in the management of knee osteoarthritis (KOA). The main questions it aims to answer are: 1. To determine the safety of the PCP-PBMCs injection 2. To compare the long-term efficacy between PCP-PBMCs and methylprednisolone on pain relief and motor function restoration 3. To analyze improving quality of life after the PCP-PBMCs treatment.
Official title: Peripheral-blood Cell Purification for PBMCs (PCP-PBMCs) Injection for Knee Osteoarthritis (PCP-PBMCs-KOA)
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-09-30
Completion Date
2029-12-31
Last Updated
2026-07-14
Healthy Volunteers
No
Conditions
Interventions
High-dose PCP-PBMCs injection
4 mL 100-200 million PCP-PBMCs injection into synovial cavity
Solu-Medrol
4 mL solu-medrol solution, injected into synovial cavity
Low-dose PCP-PBMCs injection
4 mL 20-60 million PCP-PBMCs injection into synovial cavity
Locations (4)
Chang Gung Memorial Hospital, Chiayi
Chiayi City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan