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Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis

NCT07703280 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-07-20

No results posted yet for this study

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. 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.

Conditions

Interventions

BIOLOGICAL

High-dose PCP-PBMCs injection

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

DRUG

Solu-Medrol

4 mL solu-medrol solution, injected into synovial cavity

BIOLOGICAL

Low-dose PCP-PBMCs injection

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

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital, Chiayi

    collaborator UNKNOWN

  • Kaoshiung Chang Gung Memorial Hospital

    collaborator OTHER

  • DuoGenic StemCells Corporation (DGSC)

    lead INDUSTRY

Principal Investigators

  • Jih-Yang Ko · Chang Gung Memorial Hospital

  • Po-Ting Wu · National Cheng-Kung University Hospital

  • Chih-Hao Chang · National Taiwan University Hospital

  • Kuo-Chin Huang · Chang Gung Memorial Hospital, Chiayi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07703280 on ClinicalTrials.gov