Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis

NCT07703280 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PBMC-KOA
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief 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. 1.To determine the safety of the PCP-PBMCs injection
2. 2.To compare the long-term efficacy between PCP-PBMCs and methylprednisolone on pain relief and motor function restoration
3. 3.To analyze improving quality of life after the PCP-PBMCs treatment.

Conditions

Knee Osteoarthritis

Keywords

Knee; Osteoarthritis; Peripheral blood mononuclear cells

Outcome Measures

Primary Outcomes (2)

• Mean Change in Numeric Rating Scale (NRS) Score

  Mean change in NRS for OA pain from baseline to post-treatment. NRS is a 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) with a minimal clinically important difference (MCID) of 2.0. Participants are required to indicate a score on the scale that corresponds to their perceived level of pain in their knees.

  Up to 52 weeks

• Changes in scores on the Knee injury and Osteoarthritis Outcome Score (KOOS)

  The KOOS evaluates symptoms and function in subjects with knee OA, holding five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The KOOS ranges from 0 to 100, with lower scores indicating worse pain.

  Up to 52 weeks

Secondary Outcomes (6)

• Mean Change in Numeric Rating Scale (NRS) Score

  Up to 104 weeks

• Changes in scores on the Knee injury and Osteoarthritis Outcome Score (KOOS)

  Up to 104 weeks

• Mean Change in the Visual Analog Scale (VAS)

  Up to 104 weeks

• Changes in scores on the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire

  Up to 104 weeks

• Changes in scores on the Assessment of Quality of Life 8 Dimension (AQoL-8D)

  Up to 104 weeks

Study Arms (3)

High-dose PCP-PBMCs injection

EXPERIMENTAL

Participants received PCP-PBMCs injection of 100-200 million PBMCs injection on day 1.

Biological: High-dose PCP-PBMCs injection

Low-dose PCP-PBMCs injection

EXPERIMENTAL

Participants received PCP-PBMCs injection of 20-60 million PBMCs injection on day 1.

Biological: Low-dose PCP-PBMCs injection

Solu-Medrol

ACTIVE COMPARATOR

Participants received solu-medrol solution as matching-drug on day 1.

Drug: Solu-Medrol

Interventions

High-dose PCP-PBMCs injection BIOLOGICAL

4 mL 100-200 million PCP-PBMCs injection into synovial cavity

High-dose PCP-PBMCs injection

Solu-Medrol DRUG

4 mL solu-medrol solution, injected into synovial cavity

Also known as: Methylpredinisolone

Solu-Medrol

Low-dose PCP-PBMCs injection BIOLOGICAL

4 mL 20-60 million PCP-PBMCs injection into synovial cavity

Low-dose PCP-PBMCs injection

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have taken knee, distal femur, or proximal tibia surgery.
• Patients who took an intra-articular injection of medicine, such as steroids, hyaluronic acid, or platelet-rich plasma, in the last 3 months.
• 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 have had tumor, infection, or trauma at the time of recruitment.
• Patients with abnormal blood routine test, such as severe anemia, leukemia, sepsis, platelet dysfunction, or other blood-related diseases.
• Patients who cannot agree to the withdrawal of non-steroid anti-inflammatory drugs (NSAIDs) or opioids during the trial period.
• 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.
• 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.
• Employees or family members of the PI and co-PI.

Sponsors & Collaborators

• DuoGenic StemCells Corporation (DGSC): lead
• Chang Gung Memorial Hospital, Chiayi: collaborator
• National Taiwan University Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• Kaoshiung Chang Gung Memorial Hospital: collaborator

Study Sites (4)

Chang Gung Memorial Hospital, Chiayi

Chiayi City, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jih-Yang Ko

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Po-Ting Wu

  National Cheng-Kung University Hospital

  STUDY DIRECTOR

• Chih-Hao Chang

  National Taiwan University Hospital

  STUDY DIRECTOR

• Kuo-Chin Huang

  Chang Gung Memorial Hospital, Chiayi

  STUDY DIRECTOR

Central Study Contacts

Chia-Ying Hsieh

CONTACT

+88622766193; cyhsieh@duogenicsc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)