Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03101163

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

Articular Cartilage Disorder of Knee Clinical Trial

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 and Hyaluronic Acid Adjuvant Therapy Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee With an Optional Open-Label Extension for the Standard Treatment-Controlled Group

Clinical Trial 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).

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

  • Articular Cartilage Disorder of Knee
  • Articular Cartilage; Degeneration
  • Cartilage Diseases
Clinical Trial Details
NCT number NCT03101163
Study type Interventional
Source KLSMC Stem Cells, Inc.
Contact
Status Completed
Phase Phase 2
Start date December 2015
Completion date July 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04840147 - A Comparison of JointRep® and Microfracture in Repair of Cartilage Lesions on the Femoral Condyle or Trochlea, N/A
Recruiting NCT03588975 - A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee Phase 3
Completed NCT01076673 - Effect of Autologous Peripheral Blood Stem Cell Treatment on Articular Cartilage Regeneration Phase 2
Terminated NCT03678948 - Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions N/A
Terminated NCT05082831 - Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage Phase 1
Withdrawn NCT05300490 - Prednisolone Urinary Excretion Kinetics
Recruiting NCT05924763 - The Clinical Outcome of BiCRI in the Treatment of Chondral and Osteochondral Lesions N/A
Completed NCT02118519 - Mesenchymal Stem Cells in Knee Cartilage Injuries Phase 2
Active, not recruiting NCT02524509 - the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee Phase 4
Completed NCT01576159 - Serum Cartilage Oligomeric Matrix Protein Levels After 12 Weeks of Different Exercises Phase 0