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NOT YET RECRUITING
NCT07703280
PHASE2/PHASE3

Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis

Sponsor: DuoGenic StemCells Corporation (DGSC)

View on ClinicalTrials.gov

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.

Official title: Peripheral-blood Cell Purification for PBMCs (PCP-PBMCs) Injection for Knee Osteoarthritis (PCP-PBMCs-KOA)

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-09-30

Completion Date

2029-12-31

Last Updated

2026-07-14

Healthy Volunteers

No

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

Locations (4)

Chang Gung Memorial Hospital, Chiayi

Chiayi City, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan