Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis (PBMC-KOA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Biological: High-dose PCP-PBMCs injection; Biological: Low-dose PCP-PBMCs injection; Drug: Solu-Medrol

Detailed Description

240 patients from both genders diagnosed with knee osteoarthritis, will be enrolled according to inclusion and exclusion criteria. These patients will be randomly injected with 100-200 million PBMCs, 20-60 million PBMCs or methylpredinisolone. They are then followed by clinical assessment, laboratory investigations as well as X-ray imaging of the injected knee.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Chia-Ying Hsieh; Phone Number: +88622766193; Email: cyhsieh@duogenicsc.com

Study Locations

• Taiwan
  • Chiayi City, Taiwan
    • Chang Gung Memorial Hospital, Chiayi
  • Kaohsiung City, Taiwan
    • Kaohsiung Chang Gung Memorial Hospital
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-dose PCP-PBMCs injection; Participants received PCP-PBMCs injection of 100-200 million PBMCs injection on day 1.	Biological: High-dose PCP-PBMCs injection; 4 mL 100-200 million PCP-PBMCs injection into synovial cavity
Experimental: Low-dose PCP-PBMCs injection; Participants received PCP-PBMCs injection of 20-60 million PBMCs injection on day 1.	Biological: Low-dose PCP-PBMCs injection; 4 mL 20-60 million PCP-PBMCs injection into synovial cavity
Active Comparator: Solu-Medrol; Participants received solu-medrol solution as matching-drug on day 1.	Drug: Solu-Medrol; 4 mL solu-medrol solution, injected into synovial cavity; Other Names: Methylpredinisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Reduction in Numeric Rating Scale (NRS) Score	Mean reduction 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Reduction in Numeric Rating Scale (NRS) Score	Mean reduction 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 104 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 104 weeks
Mean Reduction in the Visual Analog Scale (VAS)	Mean reduction in VAS for osteoarthritis (OA) knee pain from baseline to post-treatment. VAS is a 10-centimeter continuous scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants are instructed to mark a point along the line that best represents the intensity of their perceived knee pain. The distance in centimeters from the "no pain" anchor point is measured to quantify pain severity. Changes in VAS scores are used to assess treatment efficacy over time.	Up to 104 weeks
Changes in scores on the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire	The ICOAP is an 11-item measure that assesses pain in individuals with knee OA, taking into account both constant and intermittent pain experiences. The ICOAP is a 5-point Likert scale, ranging from 0 to 100, with higher scores indicating worse pain.	Up to 104 weeks
Changes in scores on the Assessment of Quality of Life 8 Dimension (AQoL-8D)	AQoL-8D consists of eight domains (independent living, happiness, mental health, coping, relationships, self-worth, pain, and senses) assessed by 35 items. AQoL-8D ranges from -0.04 to 1.00, with higher scores indicating better quality of life.	Up to 104 weeks
Change in Minimum Joint Space Width (JSW)	JSW is commonly used to assess knee OA progression and measured by X-ray imaging. Measurement of medial JSW was facilitated by the use of automated software that delineated the femoral and tibial margins of the joint. JSW(x) was measured at 4 fixed locations. These measures of medial JSW(x) were defined as the distance from the tibial margin to the femur margin at each fixed location on the x-coordinate system. Measurement of minimum JSW was made by the software at the location of the smallest distance between the femur and tibia margins in the medial compartment.	Up to 104 weeks

Collaborators and Investigators

• Sponsor: DuoGenic StemCells Corporation (DGSC)
• Collaborators: National Taiwan University Hospital; National Cheng-Kung University Hospital; Kaoshiung Chang Gung Memorial Hospital; Chang Gung Memorial Hospital, Chiayi
• Investigators: Principal Investigator: Jih-Yang Ko, Chang Gung Memorial Hospital; Study Director: 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 record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; Peripheral blood mononuclear cells
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Methylprednisolone; Prednisolone; Methylprednisolone Hemisuccinate
• Other Study ID Numbers: PBMC-KOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No