Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis

Sponsor
DuoGenic StemCells Corporation (DGSC)
Study ID
NCT07703280
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • High-dose PCP-PBMCs injection — BIOLOGICAL
    4 mL 100-200 million PCP-PBMCs injection into synovial cavity
  • Solu-Medrol — DRUG
    4 mL solu-medrol solution, injected into synovial cavity
  • Low-dose PCP-PBMCs injection — BIOLOGICAL
    4 mL 20-60 million PCP-PBMCs injection into synovial cavity

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-dose PCP-PBMCs injection
    Participants received PCP-PBMCs injection of 100-200 million PBMCs injection on day 1.
  • Experimental: Low-dose PCP-PBMCs injection
    Participants received PCP-PBMCs injection of 20-60 million PBMCs injection on day 1.
  • Active Comparator: Solu-Medrol
    Participants received solu-medrol solution as matching-drug on day 1.

Primary Outcome Measure

Mean Change in Numeric Rating Scale (NRS) Score [ Time Frame: Up to 52 weeks ]

Central Contacts

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