Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis
Key facts
- Where
- Chiayi City, Kaohsiung City, Tainan, and Taipei, TaiwanSee the 4 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT07703280, who can take part
Where in Taiwan
- Chang-Gung Memorial Hospital - ChiayiChiayi City, TaiwanContact: Chia-Ying HsiehNo longer taking part
- Kaohsiung Chang Gung Memorial HospitalKaohsiung City, TaiwanContact: Chia-Ying HsiehNo longer taking part
- National Cheng Kung University HospitalTainan, TaiwanContact: Chia-Ying HsiehNo longer taking part
- National Taiwan University HospitalTaipei, TaiwanContact: Chia-Ying HsiehNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- DuoGenic StemCells Corporation (DGSC)
- Trial code
- NCT07703280
- Record updated
- 20 July 2026
- Original description
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:Read full original descriptionShow less
Peripheral-blood Cell Purification for PBMCs (PCP-PBMCs) Injection for Knee Osteoarthritis (PCP-PBMCs-KOA)
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.
Inclusion: Tibiofemoral osteophytes on x-ray (Kellgren-Lawrence grade of 2-4); Age ≥ 40 and ≤ 80 years; Moderate to severe knee pain; Reduced joint space width at the medial part of the knee compared to the lateral part under x-ray examination. If standing is not feasible, the same supine position must be used consistently for follow-up; A minimal pain score of 5 measured by both NRS and VAS when walking last week; Knee pain on most days (no less than 15 days) in the 4 weeks before screening; Patients have experienced that NSAID or opioid pain medication failed to control knee pain in the last year; Patients have experienced that a single intra-articular injection of medicines, such as steroids, hyaluronic acid, or platelet-rich plasma, failed to control the knee pain over 6 months; Non-invasive treatments did not control the knee pain. Conservative and non-invasive treatment regimens may include any or all of the following: initial rest, muscle relaxants, massage, and oral medications, e.g., anti-inflammatory drugs, analgesics, narcotics/opioids; The patients have taken supervised physical and rehabilitation therapy, such as daily walking routines, therapeutic exercises, sonication, heat/cold therapy, and electric stimulation for knee pain control within the last year.
Exclusion: Patients who have taken knee, distal femur, or proximal tibia surgery; Patients who cannot agree to the withdrawal of non-steroid anti-inflammatory drugs (NSAIDs) or opioids during the trial period; Patients who have had tumor, infection, or trauma at the time of recruitment; Subjects with a history of neurocognitive disorders, or those who have sought neurological consultation due to suspected dementia or memory decline; History of post-traumatic osteoarthritis; History of rheumatoid arthritis, gouty arthritis, spontaneous osteonecrosis of the knee (SONK), or hemophilia; Patients who took an intra-articular injection of medicine, such as steroids, hyaluronic acid, or platelet-rich plasma, in the last 3 months; Patients with abnormal blood routine test, such as severe anemia, leukemia, sepsis, platelet dysfunction, or other blood-related diseases; Reduced joint space width at the lateral part of the knee compared to the medial part under x-ray examination; Patients who have severe varus deformity and tibiofemoral alignments are larger than 20 degrees; Patients who cannot cooperate with the two-year follow-up; Patients who cannot cooperate with blood drawing; The body mass index (BMI) value of the patient is higher than 30; Female subjects who are pregnant, breastfeeding, planning to become pregnant, or unable to cooperate in contraception during the trial; Employees or family members of the PI and co-PI.