Knee OsteoarthritisPhase 2/3PBMC-KOANCT07703280
Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis
A Phase 2/3 study testing High-dose PCP-PBMCs injection, Solu-Medrol and Low-dose PCP-PBMCs injection in people with Knee Osteoarthritis, run by DuoGenic StemCells Corporation (DGSC) at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- High-dose PCP-PBMCs injection, Solu-Medrol and Low-dose PCP-PBMCs injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesTaiwan
- Study dates
- 30 Sep 2026to 31 Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan4 sites
Chang Gung Memorial Hospital, Chiayi
Chiayi City
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
About this study
Official title: 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:
- To determine the safety of the PCP-PBMCs injection
- To compare the long-term efficacy between PCP-PBMCs and methylprednisolone on pain relief and motor function restoration
- To analyze improving quality of life after the PCP-PBMCs treatment.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- High-dose PCP-PBMCs injection, Solu-Medrol, Low-dose PCP-PBMCs injection
- Keywords
- Knee, Osteoarthritis, Peripheral blood mononuclear cells
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose PCP-PBMCs injectionBiological
4 mL 100-200 million PCP-PBMCs injection into synovial cavity
Solu-MedrolDrug
Also called Methylpredinisolone
4 mL solu-medrol solution, injected into synovial cavity
Low-dose PCP-PBMCs injectionBiological
4 mL 20-60 million PCP-PBMCs injection into synovial cavity
| Study group | Role | What they receive |
|---|---|---|
| High-dose PCP-PBMCs injection | Experimental | Participants received PCP-PBMCs injection of 100-200 million PBMCs injection on day 1. Receives: 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. Receives: Biological: Low-dose PCP-PBMCs injection |
| Solu-Medrol | Active comparator | Participants received solu-medrol solution as matching-drug on day 1. Receives: Drug: Solu-Medrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 52 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: Up to 104 weeks
Mean Change in the Visual Analog Scale (VAS)
Mean change 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DuoGenic StemCells Corporation (DGSC)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, Kaoshiung Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Jih-Yang Ko, Principal investigator, Chang Gung Memorial HospitalPo-Ting Wu, Study director, National Cheng-Kung University HospitalChih-Hao Chang, Study director, National Taiwan University HospitalKuo-Chin Huang, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703280
- Sponsor's protocol ID
- PBMC-KOA
- Acronym
- PBMC-KOA
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral-blood Cell Purification for PBMCs (PCP-PBMCs) Injection for Knee Osteoarthritis (PCP-PBMCs-KOA)
- ClinicalTrials.gov ID
- NCT07703280
- Acronym / sponsor ID
- PBMC-KOA / PBMC-KOA
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Peripheral blood mononuclear cells
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- DuoGenic StemCells Corporation (DGSC)Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, Kaoshiung Chang Gung Memorial Hospital
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the safety of the PCP-PBMCs injection
- To compare the long-term efficacy between PCP-PBMCs and methylprednisolone on pain relief and motor function restoration
- To analyze improving quality of life after the PCP-PBMCs treatment.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose PCP-PBMCs injection | Experimental | Biological: High-dose PCP-PBMCs injectionParticipants received PCP-PBMCs injection of 100-200 million PBMCs injection on day 1. |
| Low-dose PCP-PBMCs injection | Experimental | Biological: Low-dose PCP-PBMCs injectionParticipants received PCP-PBMCs injection of 20-60 million PBMCs injection on day 1. |
| Solu-Medrol | Active comparator | Drug: Solu-MedrolParticipants received solu-medrol solution as matching-drug on day 1. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose PCP-PBMCs injection4 mL 100-200 million PCP-PBMCs injection into synovial cavity | Biological | High-dose PCP-PBMCs injection |
| Solu-MedrolAlso: Methylpredinisolone4 mL solu-medrol solution, injected into synovial cavity | Drug | Solu-Medrol |
| Low-dose PCP-PBMCs injection4 mL 20-60 million PCP-PBMCs injection into synovial cavity | Biological | Low-dose PCP-PBMCs injection |
Primary outcome
Mean Change in Numeric Rating Scale (NRS) Score
Time frame: Up to 52 weeks
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.
Changes in scores on the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Up to 52 weeks
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.
6 secondary outcomes
Mean Change in Numeric Rating Scale (NRS) Score
Time frame: Up to 104 weeks
Changes in scores on the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Up to 104 weeks
Mean Change in the Visual Analog Scale (VAS)
Time frame: Up to 104 weeks
Changes in scores on the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire
Time frame: Up to 104 weeks
Changes in scores on the Assessment of Quality of Life 8 Dimension (AQoL-8D)
Time frame: Up to 104 weeks
Change in Minimum Joint Space Width (JSW)
Time frame: Up to 104 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jih-Yang Ko principal investigator
Chang Gung Memorial Hospital
Po-Ting Wu study director
National Cheng-Kung University Hospital
Chih-Hao Chang study director
National Taiwan University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing High-dose PCP-PBMCs injection, Solu-Medrol and Low-dose PCP-PBMCs injection in people with Knee Osteoarthritis, run by DuoGenic StemCells Corporation (DGSC) at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia-Ying Hsieh (+88622766193, cyhsieh@duogenicsc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Numeric Rating Scale (NRS) Score (time frame: Up to 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.