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

8 luglio 2026 aggiornato da: 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:

  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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

240

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • 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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: High-dose PCP-PBMCs injection
Participants received PCP-PBMCs injection of 100-200 million PBMCs injection on day 1.
Biologico: High-dose PCP-PBMCs injection
4 mL 100-200 million PCP-PBMCs injection into synovial cavity
Sperimentale: Low-dose PCP-PBMCs injection
Participants received PCP-PBMCs injection of 20-60 million PBMCs injection on day 1.
Biologico: Low-dose PCP-PBMCs injection
4 mL 20-60 million PCP-PBMCs injection into synovial cavity
Comparatore attivo: Solu-Medrol
Participants received solu-medrol solution as matching-drug on day 1.
Droga: Solu-Medrol
4 mL solu-medrol solution, injected into synovial cavity
Altri nomi:
  • Methylpredinisolone

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Reduction in Numeric Rating Scale (NRS) Score
Lasso di tempo: Up to 52 weeks
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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Reduction in Numeric Rating Scale (NRS) Score
Lasso di tempo: Up to 104 weeks
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)
Lasso di tempo: 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
Mean Reduction in the Visual Analog Scale (VAS)
Lasso di tempo: Up to 104 weeks

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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

DuoGenic StemCells Corporation (DGSC)

Collaboratori

National Taiwan University Hospital
National Cheng-Kung University Hospital
Kaoshiung Chang Gung Memorial Hospital
Chang Gung Memorial Hospital, Chiayi

Investigatori

  • Investigatore principale: Jih-Yang Ko, Chang Gung Memorial Hospital
  • Direttore dello studio: Po-Ting Wu, National Cheng-Kung University Hospital
  • Direttore dello studio: Chih-Hao Chang, National Taiwan University Hospital
  • Direttore dello studio: Kuo-Chin Huang, Chang Gung Memorial Hospital, Chiayi

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 settembre 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

8 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PBMC-KOA

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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