Trial intelligence / Profile preview

PCP-PBMCs-KOA

NCT07703280Phase 3

Key facts

Status: Not yet recruiting
Start: Sep 2026
Primary completion: Dec 2028
Countries: 1
Sponsor: DuoGenic StemCells

Drugs: PCP-PBMCs
Conditions: knee osteoarthritis (OA)

Overview

Phase 3, randomised, double-blind trial of PCP-PBMCs in knee osteoarthritis (OA) (3 arms), sponsored by DuoGenic StemCells. Primary endpoints: Numeric Rating Scale at 104 weeks and Knee injury and Osteoarthritis Outcome Score at 104 weeks. Planned start Sep 2026; status: not yet recruiting.

Design

3 arms

Study design: RandomizedDouble-blind

High-dose PCP-PBMCs injection
100-200 million PCP-PBMCs injection into synovial cavity
Low-dose PCP-PBMCs injection
20-60 million PCP-PBMCs injection into synovial cavity
Solu-Medrol
Solu-medrol solution injected into synovial cavity

Who it enrols

Patients aged 40-80 with moderate to severe knee osteoarthritis (Kellgren-Lawrence grade 2-4) who have failed conservative treatments and prior intra-articular injections, excluding those with severe varus deformity, recent knee surgery, BMI > 30, or significant comorbidities.

Endpoints

Primary

Numeric Rating Scale104 weeks
Knee injury and Osteoarthritis Outcome Score104 weeks

Secondary

Visual Analog Scale104 weeks
Intermittent and Constant Osteoarthritis Pain104 weeks
Assessment of Quality of Life 8 Dimension104 weeks
Minimum Joint Space Width104 weeks

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