Clinical Trial: Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Multicenter, Randomized, Open-Label, Standard Treatment-Controlled Parallel Group Phase 2 Study to Evaluate Efficacy and Safety of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells

Brief Summary: This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).

Detailed Summary:
Sponsor: KLSMC Stem Cells, Inc.

Current Primary Outcome:

  • International Knee Documentation Committee (IKDC) score [ Time Frame: 24 months ]
    Subjective IKDC core as a measure of joint function
  • Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain [ Time Frame: 24 months ]
    KOOS pain subdomain score as a measure of joint pain


Original Primary Outcome:

  • IKDC score [ Time Frame: 24 months ]
    Subjective IKDC core as a measure of joint function
  • KOOS pain subdomain [ Time Frame: 24 months ]
    KOOS pain subdomain score as a measure of joint pain


Current Secondary Outcome: Numeric Rating Scale (NRS) for pain [ Time Frame: 24 months ]

Numeric Rating Scale (NRS) for pain


Original Secondary Outcome: NRS for pain [ Time Frame: 24 months ]

Numeric Rating Scale (NRS) for pain


Information By: KLSMC Stem Cells, Inc.

Dates:
Date Received: March 24, 2017
Date Started: December 2015
Date Completion: September 2021
Last Updated: April 3, 2017
Last Verified: April 2017