Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis (PBMC-KOA)
16. juli 2026 oppdatert av: DuoGenic StemCells Corporation (DGSC)
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
240
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Chia-Ying Hsieh
- Telefonnummer: +88622766193
- E-post: cyhsieh@duogenicsc.com
Studiesteder
-
-
-
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
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: High-dose PCP-PBMCs injection
Participants received PCP-PBMCs injection of 100-200 million PBMCs injection on day 1.
|
4 mL 100-200 million PCP-PBMCs injection into synovial cavity
|
|
Eksperimentell: Low-dose PCP-PBMCs injection
Participants received PCP-PBMCs injection of 20-60 million PBMCs injection on day 1.
|
4 mL 20-60 million PCP-PBMCs injection into synovial cavity
|
|
Aktiv komparator: Solu-Medrol
Participants received solu-medrol solution as matching-drug on day 1.
|
4 mL solu-medrol solution, injected into synovial cavity
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in scores on the Knee injury and Osteoarthritis Outcome Score (KOOS)
Tidsramme: 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.
|
Up to 52 weeks
|
|
Mean Change in Numeric Rating Scale (NRS) Score
Tidsramme: 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.
|
Up to 52 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in scores on the Knee injury and Osteoarthritis Outcome Score (KOOS)
Tidsramme: Up to 104 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.
|
Up to 104 weeks
|
|
Changes in scores on the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire
Tidsramme: Up to 104 weeks
|
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)
Tidsramme: Up to 104 weeks
|
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)
Tidsramme: Up to 104 weeks
|
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
|
|
Mean Change in Numeric Rating Scale (NRS) Score
Tidsramme: Up to 104 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.
|
Up to 104 weeks
|
|
Mean Change in the Visual Analog Scale (VAS)
Tidsramme: Up to 104 weeks
|
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. |
Up to 104 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jih-Yang Ko, Chang Gung Memorial Hospital
- Studieleder: Po-Ting Wu, National Cheng-Kung University Hospital
- Studieleder: Chih-Hao Chang, National Taiwan University Hospital
- Studieleder: Kuo-Chin Huang, Chang Gung Memorial Hospital, Chiayi
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. september 2026
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
31. desember 2029
Datoer for studieregistrering
Først innsendt
8. juli 2026
Først innsendt som oppfylte QC-kriteriene
8. juli 2026
Først lagt ut (Faktiske)
14. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PBMC-KOA
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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